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Nov 19, 2020
COVID-19 Clinical Trials: News Digest
The race is on to find a COVID-19 vaccine or treatment. As a result, there are many clinical trials taking place around the world. At the same time, COVID-19 is also impacting ongoing clinical trials for other serious illnesses. This news digest includes the latest on clinical trials, both advancements to speed up COVID-19 trials and impacts of the pandemic on ongoing clinical trials. EMA publishes safety monitoring plan and guidance on risk management for COVID-19 vaccines. The plan is to ensure that all new information collected post-marketing will be promptly reviewed and any emerging new information will be shared with the public in a timely manner. Read more. Pfizer and BioNTech conclude Phase III study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Read more. Moderna COVID-19 vaccine candidate meets primary efficacy endpoint. The Phase III study of mRNA-1273 met the statistical criteria pre-specified in the study protocol, with a vaccine efficacy of 94.5%. Read more. FDA authorizes monoclonal antibody for treatment of COVID-19. The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. The EUA was issued to Eli Lilly. Read the details. Novavax COVID-19 vaccine granted fast track designation by FDA. Novavax announced that the FDA has granted Fast Track Designation for NVX-CoV2373, the company’s COVID-19 vaccine candidate. The company expects to begin its pivotal Phase III clinical trial in the United States and Mexico by the end of November. Read more. October 2020 EMA implements extra transparency measures for COVID-19 vaccines and therapeutics. The European Medicines Agency (EMA) has published clinical data in support of the authorization of Veklury (remdesivir) and information on COVID-19 treatments and vaccines that have received scientific advice or informal guidance from its pandemic task force. Read the article. FDA approves first treatment for COVID-19. The US FDA approved antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years and older and weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Read the article. Eli Lilly pauses trial of antibody drug over safety concern. The ACTIV-3 clinical trial is paused because of a safety concern. Read the article. J&J pauses coronavirus vaccine trials due to unexplained illness. Johnson & Johnson said the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians. Read the article. EMA starts second rolling review, this time for Pfizer COVID-19 vaccine. The European Medicines Agency's human medicines committee (CHMP) has started a "rolling review" of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. Read the details. FDA publishes vaccine rules. The FDA released new safety standard for COVID-19 vaccines, with guidance that vaccine makers should follow clinical trial participants for at least two months to rule out safety issues before seeking emergency use authorization for a vaccine. Read the article. FDA reshuffles priorities to meet COVID-19 trial demand. The sudden influx of COVID-19 trials work at the FDA has required pulling resources from various departments at the agency to support the efforts. Read the article. Eli Lilly rushes to FDA with its COVID-19 antibody for emergency green light, reveals new cocktail therapy data. Lilly submitted an initial request for emergency use authorization for its antibody treatment, specifically for higher-risk patients who have been recently diagnosed with mild to moderate COVID-19. Read the article. GSK and Vir to expand COVID-19 antibody treatment study. GSK and Vir Biotechnology are set to globally expand the study of experimental antibody VIR-7831 for the early treatment of COVID-19 patients with a high risk of hospitalization to Phase III. Read the article. How research nurses and midwives are supporting COVID-19 clinical trials in the UK. Clinical research nurses and midwives have been central to the rapid implementation of COVID-19 clinical trials. Read the article. EMA begins real-time review of AstraZeneca’s COVID-19 vaccine. The European Medicines Agency initiated the first "rolling review" of a COVID-19 vaccine developed by AstraZeneca and the University of Oxford. Read the article. September 2020 Pfizer follows Moderna in releasing COVID-19 vaccine study protocol. Protocols are typically kept under wraps until studies are complete, but Pfizer and Moderna have made their SARS-CoV-2 trial protocols public in a transparency push. Read the article. First patient in OSCAR trial receives GSK’s otilimab in UK. The Manchester University NHS Foundation Trust in the UK has said that the first patient in the OSCAR clinical trial received GSK’s investigational drug otilimab to treat severe lung disease related to COVID-19. Read the article. Johnson & Johnson’s single-dose COVID-19 vaccine generates strong immune response, early data shows. The company released positive interim results of its Phase I/IIa study. It has moved into a Phase III trial that will enroll up to 60,000 volunteers across three continents. Read the article. Older people likely to be underrepresented in COVID-19 trials. A study published in JAMA Internal Medicine concludes that despite the fact that people over 65 are disproportionately impacted by COVID-19, they are underrepresented in the clinical trials. Read the article. Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance. Investigators should review and report AEs and SAEs, according to updated FDA guidance. Read the full article. Pfizer and BioNTech propose expansion of pivotal COVID-19 vaccine trial. The companies have submitted an amended protocol to expand the enrollment of their Phase III pivotal COVID-19 vaccine trial to up to 44,000 participants. Read more. UK’s MHRA allows restart of Oxford/AstraZeneca COVID-19 vaccine trials. The Medicines Health Regulatory Authority (MHRA) in the UK has said that the clinical trials of the Oxford/AstraZeneca COVID-19 vaccine candidate are safe to resume. The late-stage trials were paused after a participant in the UK study experienced an unexplained illness. Read the full article. Biopharma leaders unite to stand with science. Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. Read the pledge. Sanofi and GSK move COVID-19 vaccine into human trials. Sanofi and GSK are launching a large Phase I/II clinical trial at 11 sites across the US, initially enrolling 400 people. This candidate is the first outside of China to use a vaccine approach for which there is already a licensed vaccine. Read the full article. Sanofi says Kevzara drug fails as possible COVID-19 treatment. The international Phase III clinical trials of Kevzara didn't meet primary or secondary endpoints and as a result trials will be stopped. Read the full article. August 2020 Phase III clinical testing of AstraZeneca COVID-19 vaccine candidate begins. A multi-site, Phase III clinical trial for AZD1222 has begun. The trial will enroll 30,000 adult volunteers at 80 sites in the US. Read more. Translate Bio, Sanofi COVID-19 vaccine proves promising in animal studies. Experimental COVID-19 vaccine induced immune responses in animal studies. The companies plan to start human trials in November. Read the full article. COVID-19 and readjusting clinical trials. The disruptions from the pandemic are numerous, but there are some reasons to be optimistic about changes with clinical trials, according to the Lancet. Read the full article. COVID-19 clinical trials must append more diversity, researchers assert. Researchers raise concerns about the lack of diversity in COVID-19 clinical trials. Read the full article. Disruptions to global oncology trials have fallen to a three-month low. Cancer trials disrupted by COVID-19 are resuming faster than other therapeutic areas. Read the full analysis. July 2020 FDA Coronavirus Treatment Acceleration Program (CTAP) dashboard. This dashboard provides updates specifically on therapeutics (not vaccines or devices). View dashboard. Many early COVID-19 studies have low-quality design, risk low-value evidence, research finds. The researchers estimated that only about 29% of studies would produce data strong enough to potentially inform changes in clinical care. Read the full article. US biotech uses AI to pick antiviral for COVID-19 trial. US biotech AI Therapeutics begins a Phase II trial of its LAM-002A, an antiviral drug. The company develops drugs identified with a proprietary artificial intelligence (AI) algorithm. Read the full article. "Promising" data on Oxford/AZ coronavirus vaccines. Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus. Read the full article. Moderna COVID-19 vaccine candidate has positive results in all participants in Phase I trial. Moderna published interim analysis of the open-label Phase 1 study of mRNA-1273 in the New England Journal of Medicine. A Phase III trial is expected to start later in July. Read the report. NIH launches trials network for COVID-19 vaccines and therapies. The COVID-19 Prevention Trials Network (COVPN) is expected to operate more than 100 trial sites across the US and internationally. The first Phase III trial conducted is expected to be Moderna’s mRNA-1273 vaccine. Read the full article. UK universities launch new COVID-19 drug testing platform. The University of Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit launched a COVID-19 drug testing platform called AGILE. It will test multiple potential therapeutics. Read the full article. UK trial begins testing second-wave COVID-19 drug from US biotech Ridgeback. Ridgeback Biotherapeutics is starting enrollment for a Phase II trial for its oral antiviral drug EIDD-2801, which will be conducted using the AGILE testing platform. Read the full article. June 2020 Running clinical trials for other drugs in the age of COVID-19. There is some evidence of recovery for clinical trials beyond COVID-19. Read the full article. Some COVID-19 trial sponsors never posted other study results in an EU database. Will they hide data again? Two-thirds of 118 COVID-19 clinical trials analyzed by the non-profit research advocacy group TranspariMED had no record of uploaded results to the European Union Drug Regulating Authorities Clinical Trials Database, though it is required under EU rules. Read the full article. MHRA instructs all UK hydroxychloroquine COVID-19 clinical trials to suspend recruitment. UK clinical trials using hydroxychloroquine to treat or prevent COVID-19 should stop recruiting further participants, Medicines and Healthcare products Regulatory Agency (MHRA). Read the full article. COVID-19 vaccine development pipeline gears up. There are 10 COVID-19 vaccines in clinical trials. They are working at a rate that could defy usual timetables, which on average is 10 years to develop a new vaccine. Read the full article. FDA’s MyStudies app provides platform for electronic informed consent. The U.S. Food and Drug Administration is making its FDA MyStudies app available to investigators for free to obtain informed consent from patients when face-to-face contact is not possible or practical due to COVID-19. Read the full article. May 2020 How COVID-19 could improve clinical trial conduct. Sheuli Porkess Director, Research, Medical and Innovation from the Association of the British Pharmaceutical Industry talks about three areas for change with clinical trials. Read the full article. The COVID-19 pandemic and clinical trial disruptions. Nearly 70% of global clinical trials have been disrupted by enrollment suspensions, according to research. Read the full article. FDA updates COVID-19 clinical trials guidance to address serious adverse events. The FDA updated guidance for clinical trial conduct, including how and when serious adverse events should be reported. Read the full article. Institute for Advanced Clinical Trials for Children launches program to speed up COVID-19 pediatric trials. The Institute for Advanced Clinical Trials for Children (I-ACT for Children) launched the COVID-19 Emergency Access Program to speed up the development of pediatric COVID-19 trials. Read the full article. Clinical trials press on for conditions other than COVID-19. Will the pandemic’s effects sneak into their data? Researchers will need to adjust their studies during the pandemic. Disruptions to movement and visit schedules and/or sickness or death caused by COVID-19 could impact the data of ongoing clinical trials. Read the full article.
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Nov 18, 2020
Introducing Teckro Connect: Clinical Trial Communication in the Hands of Research Staff
There is a gap in clinical trial communication. In fact, it is a chasm separating those conducting research and those with study expertise.   Considering how hard it is to execute clinical trials today, logic would say that sponsors and CROs should do everything in their power to make it as easy as possible for research staff to ask questions or clarify their interpretation of protocol instruction. But until now it’s been hard work for investigators and site staff to get in touch with study experts. Depending on the urgency, they may call, email or use some other non-compliant communication app to reach their main point of contact, often a study monitor. This then kicks off either a game of telephone or an email loop, neither of which are designed for expedited answers. The Game of Telephone If you’ve ever played the “game of telephone” as a team building exercise, it is interesting how the fidelity of the message degrades as it passes from person to person. What it shows is the farther away from the source, the less accurately information is conveyed. Generally, it isn’t something malicious – it’s just the nature of how communication flows. For example, if you have limited knowledge on the subject, you may not be equipped to completely and accurately relay the information. Or you might be distracted during the conversation so that you may not capture the entire story.  In turn, what you convey downstream is not quite complete. Caught in the Email Loop Email is better served as a channel to inform than it is to resolve time sensitive queries.  Depending on the number of forwards and how long it takes for the information to make its way along a chain of people, it could be too late or even outdated by the time it reaches the intended recipient. Additionally, email can be open to misinterpretation. For example, we may be unintentionally biased in reading what we think the email says, instead of what it actually says. This could lead to a mismatch of the answer sent back that is not actually to the original question. And If further clarification is needed, the whole email thread kicks off again. Introducing Teckro Connect When we look at clinical trials, particularly when physicians and research staff need time sensitive answers, the way communication is handled today is akin to the game of telephone or the email loop. Simply put: neither are fit for purpose.    That is why we are introducing Teckro Connect. Teckro Connect puts the power directly in the hands of research site staff to ask questions of study experts. It sits within our digital engagement suite, so the user can switch from a keyword search to requesting medical advice – all within Teckro. And it is compliant with industry regulations, including 21 CFR Part 11. Let’s take the example of a doctor who is with a participant and needs an immediate answer related to dose modification. I’ll contrast the “old way” and the new way with Teckro Connect.
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Nov 10, 2020
Why Clinical Trial Data Transparency is Critical in the Age of COVID-19
At the heart of it, clinical trials are about data. By testing treatments and drugs, researchers seek to measure how well they work and quantify possible side effects. Regulators need data to make informed decisions about which treatments and drugs they will approve – and for what specific indications. As we are all acutely aware, researchers around the world are working on COVID-19 treatments to lessen the severity if you get the virus and vaccines to put an end to the pandemic. In this extraordinary time, everyone is trying to move quickly. But even if time is of the essence, we need to balance safety with speed. There’s just too much at stake to rush decisions that aren’t supported by data. And the data should be transparent so healthcare professionals and the public in general have access.   At the risk of stating the obvious: clinical trial data needs to be made available sooner rather than later. In a positive step for data transparency, the European Medicine Agency (EMA) decided to publish clinical data for COVID-19 medicines. The first results published were the data that supported the authorization of Veklury (remdesivir). EMA will also publish information on the COVID-19 treatments and vaccines that have received scientific advice or official guidance from its pandemic task force.   Data sharing means that the whole research community can be involved. This can be especially useful when pandemics occur. For example, during the Ebola epidemic six years ago, data sharing meant that the virus was rapidly able to be controlled. Additionally, research duplication can be reduced when resources are pooled through data sharing. Expectations for Publishing Clinical Trial Results As it stands, FDA rules require clinical trial sponsors to post results to Clinicaltrials.gov one year after a study has finished. Yet, research earlier this year from Science shows that sponsor organizations continue to miss the reporting deadline. Some have downplayed concerns about missing deadlines for ClinicalTrials.gov, saying that instead researchers, doctors, and patients can learn about trial outcomes from peer-reviewed publications. But the reality is that thousands of trials are never published, particularly when treatments are found not to be effective. Over the last few years, we have seen efforts to tackle the missing data. For example in 2013, The BMJ announced that it would “no longer publish any trial of drugs or devices where the authors did not commit to making the relevant anonymized patient level data available, on reasonable request.” And in February 2020, hundreds of universities, drug companies and medical device manufacturers were ordered by a federal judge in New York to post missing trial data for trials conducted on drugs and devices over the last 10 years. Building Transparency into Clinical Trial Process Maybe it sounds ambitious to expect reported results for all clinical trials. But as we are seeing backlashes now from people who either don’t want to participant in COVID-19 clinical trials or are already gearing up to reject a vaccine – it is critically important that clinical trial findings are transparent. But if we look at the way trials are run today, there are so many parts where data transparency just isn’t there. We need to look at building data visibility into the entire process of clinical trials – not just the reporting of completed trials. This is why we founded Teckro: on the belief that clinical research must be simpler, more accessible and transparent. In the current climate, data openness is no longer a “nice-to-have” but a “must-have.” During the clinical trial process, our technology ensures that there’s full transparency for all stakeholders – from sponsors, to monitors, to physicians and research staff. In the end, everyone benefits if they have greater insight and visibility into study activity. What I’m talking about is bigger than simply the “traditional” clinical trial data that is documented with each patient and each visit. I’m talking about the data – the visibility – into the trial itself. This ranges from what sites are engaged with the protocol to what kind of questions research staff have about specifics in the protocol. You may not think of questions as data. But the reality is that each site question contributes to a pool of questions. And what if the sponsor could identify a pattern that multiple sites are looking for information because of an adverse event, say a skin reaction. Taken together, these individual questions form a pattern that can be an early indicator of a potential safety risk.  This transparency just isn’t possible when the protocol is a static paper document.   Not only does this greatly improve the relationship between physicians and sponsors – ensuring more confidence and honesty – it also can make trials safer and more efficient. Fewer protocol deviations mean better trial quality. And greater data transparency speeds up the drug-to-market timeline. Everyone benefits. Building Good Faith with Patients and Doctors Over the next few years clinical trial transparency needs to be an urgent focus for both governments and the wider industry. The pandemic demonstrates that it is of the utmost importance that public health institutions can act at speed during times of crisis.  As well as this, the public needs to feel they can have faith in the clinical trial process. With data transparency, patients and doctors are more confident because they can see the results for themselves. For those patients participating in research, it is important that they know that the data they helped contribute to is made widely available. The pandemic is pushing the industry to change on several levels. Greater transparency and a more modern approach to clinical trials are good for everyone. Once we are past COVID-19, these changes will hopefully be entrenched and there’s no going back.
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Oct 14, 2020
Rallying the Global Community to Tackle Inadequacies for Women with Ovarian Cancer
Teckro is partnering with the World Ovarian Cancer Coalition to support its global initiatives to improve quality and access of care for women with ovarian cancer. Guest blogger Clara MacKay, CEO of the World Ovarian Cancer Coalition, explains why a sense of urgency is needed for ovarian cancer – a deadly cancer that is often caught when it’s too late. 
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Oct 08, 2020
Part 2: Clinical Quick Reference Guides – The Ultimate, On-Demand Quick Reference Tool
In Part 1 of this blog series Clinical Quick Reference Guides - When “Quick” Isn’t Fast Enough, I talked about how clinical trial study teams have tried to help research staff manage with quick reference guides, aka "cheat sheets.” I never want to discourage efforts that support research staff as they need help on the frontlines to keep clinical research going. But the data shows that these cheats sheets really don’t result in dramatic time savings or reduce effort for site staff. So the question is: Why keep doing something that doesn’t work? In this blog, I want to challenge study teams to think differently about how they can really help research site staff. We’ll look at a new approach to quick reference guides that are more akin to how investigators, study coordinators and CRAs operate in their daily lives. (Spoiler alert: it starts with a smartphone.) Aren’t we in the 21st Century? I recently saw a post online by an individual in the clinical research industry asking for tips or methods for learning and retaining protocol content in order to increase efficiency.  Tips she got back from the community ranged from:    Printing the protocol and highlighting and/or adding tabs to sections Taking notes in OneNote or handwriting them Creating cheat sheets Using FAQ logs Creating an Excel sheet with the schedule of assessments Doing a PDF CTRL+F search of the protocol And then I thought to myself, Are we not in the 21st century?! Admittedly, some of the people who did comment called themselves “dinosaurs” and that their methods were “old school.” However, this young woman asking for guidance is starting off on the wrong foot. We rely on our smartphones to manage just about everything in our lives. And both information and interactions with our friends, families and colleagues are just a swipe on our phone away. And the great thing is no one has to be particularly tech savvy to benefit from a smartphone. Research staff getting answers to study specific questions should be as easy as taking out a mobile device from a pocket and asking a question – just like they do to find out the weather forecast or to send a quick message to a friend. Teckro – 21st Century protocol in your pocket The idea of cheat sheets, quick reference guides and FAQs is to give research staff fast answers to common questions. The limitations are that they are generally on paper, inconveniently stored, and outdated when there are study updates or protocol amendments. So what if we take this idea of fast answers and make them always available whenever an investigator, study coordinator or CRA has a question. What if the search for answers analyzed only current versions of the protocol and other study documents. And what if it was just in your pocket on your smartphone, where you instinctively go for any other answer. This is Teckro. It is the study protocol in your pocket. But unlike paper documents, it is also a lot more. It gives a wealth of insight that is particularly useful for study teams and monitors. On-demand answers that aren’t high maintenance. Teckro is always the right, approved version of the protocol. Amendments are handled seamlessly in the background so sponsors don’t need to worry if sites are referencing the most current version. CRAs don’t have to spend time to distribute amendments. And site staff (or study teams) don’t have to spend time creating cheat sheets. Saving just a few hours per week or per month is very valuable.  If you multiply that across all the studies happening at any given time, it could add up to days of improved productivity and more time to spend with patients. Schedule of assessment that is actually simple. As I mentioned above, one of the old tricks to make the schedule of assessments understandable is to create an Excel sheet with procedures in columns and visits in rows. Now this brings a host of problems, starting with the time it takes to actually create this file. And then, how is it maintained if there are changes? And where is the file available – on a desktop computer tucked far away from where treatment occurs? With Teckro, simply type in “visit schedule” and the instructions are returned from the correct version of the protocol.  Or more precisely, someone could type in “visit 14” and the procedures for this visit are returned in seconds. Study teams can also proactively send reminders or other timely guidance to research staff to help coach them for a given visit. This can help to reduce deviations and also improve the quality of care in accordance with the protocol.
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Sep 22, 2020
Getting Oncology Clinical Trials Back on Track after COVID-19
The COVID-19 pandemic has caused enormous disruptions to clinical trials across the world. It is estimated that around 80% of non-COVID trials have been stopped or interrupted due to concerns about patient safety. Vulnerable populations who participate in trials are most affected by the virus, so it makes sense that many of these trials have not gotten back to normal – even as restrictions ease. At the same time, the devastating effect that this closure has had on medical research cannot be ignored. In the UK more than 1,500 clinical trials of new drugs and treatments for cancers, heart disease and other serious illnesses have been permanently closed. As well as this, 9,000 have been suspended and most will need large cash injections to be reactivated. That this is a problem cannot be stated enough – especially when it comes to oncology trials. According to the World Health Organization, cancer deaths are the second leading cause of death globally and the disease was responsible for an estimated 9.6 million deaths in 2018. As well as this, oncology trials typically have a low success rate and longer recruitment times due to stringent patient inclusion criteria and cannot afford to be further delayed. While there is some good news - globally more than a third of oncology trials have now started up again. As a society, we must not get off-track after we have come so far in the fight against cancer. It is understandable that talk of “back to normal” may seem premature to some - but the last few months have seen a tremendous uptake of new technologies by sponsors and site staff to keep clinical trials functioning where possible. For the clinical trials industry, this is not “normal.” It is revolutionary and all of us in the industry should do our best to ensure that this change in trial management process paves the way for as many trials as possible to get (safely and quickly) up and running again. Technology is the way forward Trials that were stopped, in many cases were stopped from enrolling new patients. But where they could, sponsors moved at hyper speed in their adoption of solutions such as decentralized trials, wearables and real-time communication technologies. The usually conservative pharmaceutical industry has demonstrated that it can move fast when necessary. The genie is out of the bottle about the amazing opportunity the industry has to completely rethink the future management of trials. Picture a world where trials were run at maximum efficiency and drugs got to market much faster. Where the diversity problem could finally be addressed, as neglected and underrepresented groups could have more flexibility, addressing the gender and ethnic minority gap. And we would know that during times of global crisis and chaos (such as another pandemic) clinical trials could keep going. The new habits that the industry would have to adopt is a small price to pay for this peace of mind. Patient enrollment and oncology trials Patient enrollment is one key area where technology could have a huge impact on speed and efficiency. As mentioned above, inclusion criteria are especially strict for oncology trials. Many studies have exclusions based on whether patients have had chemotherapy, have an advanced stage of the disease or have not recently been diagnosed. In fact, according to figures from the National Center for Biotechnology Information, 16% of protocol amendments are due to changes in inclusion/exclusion criteria. Oncology trials also have lower completion rates across all phases. Analysis of clinical trial data from 2000 to 2015 by Oxford Academic, showed that just 73.9% of the trials reached completion, with the median duration for oncology rates 13.1 years in comparison to 5.9 to 7.2 years for non-oncology trials. Typically, oncology trials have a lower approval rate as well, which, according to Oxford Academic, could be as low as 3.4%. And FDA approval in the United States currently has a 97% failure rate, generally due to issues with drug efficacy or toxicity. Treatments can be also very targeted, based on specific genetic markers, making it much harder to find suitable patients in comparison to non-oncology trials. This is where biomarkers can help. Biomarkers predict responses to oncology drugs, so if patients can be screened for the biomarker before enrolment, then there is a much higher chance that the patient will respond to the treatment. Additionally, by expanding the pool of research sites and investigators, this too can help with patient enrollment. As we’ve written in many of our blogs, by working with more novel research sites, the standard of care with clinical trials can be available to those who otherwise may be left behind because of socioeconomic factors, geography, or general lack of access to clinical trials. Technology to make the conduct of clinical trials simpler will go a long way in expanding the number and the diversity of investigators and research sites. Ticking time bomb of cancer delays The complexity of oncology clinical trials means that technology can be especially useful when it comes to speeding up patient enrollment. Rather than having to constantly seek out the protocol to confirm eligibility, typically tucked away in a paper format or on a portal on a desktop computer somewhere, real-time access like what we can provide with Teckro allows physicians and research staff get immediate answers from their digital device right then and there. This is saving precious time and also improving the decision-making process of which participants to enroll into a given study. As oncology trials take longer and have a low success rate, any further delays in clinical trials will be devastating for millions of people worldwide over the next few years. There is already a huge cancer care backlog with millions of patients around the world facing delays in diagnosis and treatment. It is imperative that we learn valuable lessons from the pandemic so we can keep trials – especially oncology trials – running during future emergencies. We cannot forsake clinical trials every time there is a global pandemic - there is too much at stake.
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Sep 09, 2020
Diversity in Clinical Trials: How Sponsors Can Help Close the Gap
Recently I wrote about how important it is to put a “face” to the people who should seek out clinical trials but don’t. Accessibility to clinical trials for underrepresented groups remains a problem – and one we are seeing more in mainstream media with COVID-19 clinical trials. The solution requires a concerted effort on the part of both sites and sponsors to build trust and reach those who will benefit from the treatment. Simultaneously, drug development itself will benefit from a more comprehensive dataset to evaluate safety and efficacy among the population who would actually need the treatment. In our webinar "No One Left Behind: Addressing Clinical Trial Access and Issues Blocking Physician Participation” we had representation from both the site and sponsor perspective. In this blog, I’ll focus on the recommendations for sponsors, which was delivered quite eloquently by Cassandra Smith, Director of Diversity & Inclusion in Clinical Trials at The Janssen Pharmaceutical Companies of Johnson & Johnson. Sponsors play an important role when it comes to plugging the diversity gap in clinical trials. We discussed during the webinar just how vital it is to understand the link between sponsors and sites. After all, sites shape how trials are conducted and can help make them more accessible to historically underrepresented populations. Sponsors need to partner up with the right sites to achieve this. Racial Representation Mismatch with Disease Prevalence Cassandra shared statistics from the Tufts Center for the Study of Drug Development that showed that ethnic populations in the US made up of Blacks, Asians and Latinos represented just 24% of trial participants over the span of a decade. But what is perhaps more eye opening is adjusting for the prevalence for the diseases across 18 therapeutic areas, you can see just how underrepresented certain groups really are. This means that the groups who are more likely to need the treatments being researched are not actually represented in the trials. Let us start by considering why the diversity gap exists. There are a few key factors that influence the lack of marginalized groups taking part in clinical trials, such as: Access to care, including site selection Competing demands, such as working hours that could conflict which clinic hours Language and literary barriers, particularly given the complex topics associated with clinical trials Mistrust and misinformation about clinical research, healthcare and the pharma industry in general   Sponsors: Making Inclusion and Diversity a Priority One of the key messages that Cassandra had is that intentional site selection is important for addressing the diversity gap. In her presentation, she outlined a few ways for sponsors to approach this: Meet patients where they are Sponsors can apply a data-driven approach to identify sites located in certain areas to reach underserved and unrepresented populations. This is adding diversity as another criteria when evaluating data in site selection, which may then lead to different decisions in which sites are best suited for a given clinical trial. Connection with community Health Care Professionals (HCPs) Sponsors can partner with trial sites that have relationships with relevant HCPs as well as knowledge of the eco-systems through which the patients navigate. Powerful connections with communities can be built by leveraging these networks. Patients will be more comfortable if they are recommended for trials by familiar sources. Expansion and growth of the site pool They can seek out sites that are not “known” in industry-sponsored research but may have government research experience. The site pool could also be expanded by providing support to HCPs who are new to clinical research experience and increasing knowledge about underrepresented patient populations. The Time Is Now Let’s face it: clinical trials are not without risk as they involve testing on humans. Rightly so, industry regulations and guidelines are oriented towards risk mitigation to protect participant safety and preserve data integrity. Given that the industry is working hard to avoid risk, we know that change can be scary as many people aren’t comfortable with change. However, coming from inside the pharma world, Cassandra articulated why sponsors need to think differently to address this diversity problem. In fact, you could argue that sponsors are putting themselves in a risky position by not increasing diversity in trials. Demographics are shifting, the world is changing, and a proactive approach is needed to solve the inclusion gap to prepare for the future. As clinical trials are currently in the forefront of our minds due to COVID-19, now is an excellent chance to rethink how trials can be made more inclusive for those who have been left behind. Yet, even with COVID-19 trials, there are concerns of underrepresentation of ethnic groups. As Cassandra put it, a thoughtful approach is necessary to site selection when it comes to ensuring the best support for minority patient populations who want and need access to therapies. The opportunity has presented itself for sponsors to put themselves at the center of the conversation to make much-needed changes and to solve the clinical trials diversity problem once and for all.
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Aug 27, 2020
Part 1: Clinical Quick Reference Guides - When “Quick” Isn’t Fast Enough
We spend a lot of time talking about complexities of clinical trials. But take a moment to consider, what actually is making things complex? First, there is the fact that the number of clinical trials is skyrocketing. From 10 years ago when there were 100,212 trials registered with ClinicalTrials.gov, it is now projected that there will be more than 348,600 trials in 2020. The sheer volume alone puts pressure on research sites to support the needs of the industry.
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Aug 12, 2020
Technology Can Be a “Guardian Angel” on the Shoulder of Investigative Site Staff, a Perspective From Drug Development Expert Dr. Ellen Vigdorth
Guest blogger Dr. Ellen Vigdorth shares her perspective on how technology is a key enabler to avoid a “multiplier effect” of errors for faster, safer and more efficient infectious disease clinical trials. In today’s rapidly changing environment, speed is everything in infectious disease trials. For the best probability of success, investigative site staff need immediate answers and real-time updates. But let’s face it, we don’t make it easy for site staff today. Depending on the trial, you may have multiple protocol amendments, even country level amendments, so it can be challenging for study coordinators and physicians to stay current on the latest study guidance. You may need to know the status of a cohort so you can control screening to cohort closure. Avoiding the "Multiplier Effect" In vaccine trials, the consequences of errors are quickly multiplied. The last thing you want is to lose an entire cohort or day of enrollment due to replicated errors. I call this the “multiplier effect.” For example, if we didn’t take specimens appropriately or complete assessments correctly, this would have a knock-on effect and every specimen/assessment could be lost for efficacy evaluation that day. Investigators and study coordinators want to be compliant with the protocol and avoid deviations because of potential impacts to patient safety and the study results. The issue is that there’s a real need to make quick decisions, especially when it comes to vaccine trials, because time is of the essence. The way trials are conducted today, it can be hard work for site staff to be both accurate and efficient. For this reason, vaccine trials need to be more collaborative and immediately interactive than perhaps any other type of trial. Best practice sharing among different sites, means study coordinators can learn from their peers about what is working and what’s not so that they can adapt at their own facility. But today, collaboration and communication are time consuming. For example, I was involved in trials where study coordinators and CRAs had three calls a day – morning, midday and evening. The morning briefing would provide any adjustments or updates to safety information. The midday briefing would be a midpoint check on enrollment. The evening briefing was a summary of the day. Let’s say there is a safety hold that happens after the morning briefing. That notification needs to go out immediately – not held for the next briefing call. And it certainly isn’t going to help the staff if they get a fax or an email about it. As we typically enroll large numbers of subjects each day in vaccine trials, we need to be aggressive in management and communication. Real-time decisions and the communication of information are critical for patient safety. The Opportunity for Technology Anything that makes it easier for the site to be supported in a timely manner and reduces friction that inhibits enrollment and performance would be hugely appreciated. Technology needs to be nimble, flexible and readily adopted to be successful. I see the opportunity for technology to act as a “guardian angel” on the shoulder of research staff, to coach them with the right answers. Should dosing be delayed, deferred to later or terminated if the subject/patient has certain symptoms? What are acceptable concomitant medications when considering eligibility? If study subjects come in late in the afternoon, do they get both the morning and afternoon dose, pm dose or am dose? The point is that the protocol and study advice should be readily available for all investigative site staff in a simple, straightforward manner. Time is wasted if they have to hunt through text messages, faxes, emails and voicemails. If the protocol and essential guidance are simply and immediately available on demand, I believe the right subjects/patients can be enrolled faster, there would be fewer procedural errors, and physicians can quickly identify the best course of action based on symptoms. Sponsors and CROs will see other benefits in providing more of a self-service model for investigative staff. Take for example the army of people working 12 hour shifts to keep pace with the volume of site inquiries. Or the go-between time and effort it takes for a CRA to get an answer from a medical expert, instead of just providing a direct and quick line of communication in the first place. It also means that sponsors and CROs can show the regulators that they took the appropriate corrective action during the trial. If you think about the “tunnel effect” in Infectious Disease trials, staff are frequently clad in personal protective equipment (PPE) in the patient’s environment. It’s hardly the case that they will get out of their gear to refer to the regulatory binder or log on to a desktop computer to find an answer. They already have their smartphones with them as a resource, so why couldn’t they use it to access the protocol and other study guidance? They don’t have the time to call their CRA – and for younger medical and nursing staff, it is a natural instinct to take out their phones to find an answer. This would completely change the game for fast moving clinical trials. About Dr. Ellen Vigdorth Dr. Ellen Vigdorth has more than 25 years of drug development experience, spanning investigative research sites, global pharmaceutical companies, and contract research organizations (CROs). She has led clinical development programs across a range of therapeutic indications, including allergy, respiratory, vaccine and anti-infective agents. Ellen spent more than 20 years in various roles at IQVIA (formerly Quintiles). Initially trained as a microbiologist, she holds a PhD in infectious disease epidemiology from the University of Cincinnati College of Medicine.
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Jul 29, 2020
Why Are We Still Throwing Protocols over the Wall to Site Staff?
Findings in the Tufts CSDD-Teckro study are important for the industry to discuss There was a time when telephone companies distributed fat paper directories each year. White pages for personal numbers, yellow pages for business listings. Typically, they were delivered during the day to our homes, when most of us were at work. This meant they were left in mailboxes, on doorsteps and in hallways. Generally, mine was thrown over my garden wall and then sat for hours withstanding the weather of the day. I imagine that the phone company presumed that I used the directory, but they had no way of knowing for sure. And they probably also expected that I used the most current directory, but they couldn’t know that actually I often used an older one. Consider the millions of trees used to publish a new directory each year, when in reality the producer didn’t know when, or even if, it was used. With smartphones, printed phone directories are all but extinct. Clinical trial sites are still stuck in that past It is disappointing – but not surprising – to see the results of the industry research we conducted in collaboration with Tufts Center for the Study of Drug Development (CSDD). Paper is still heavily used at sites, along with static PDFs accessed from desktop computers. You could say that essential study documents like protocols are still “thrown over the wall” to sites, just like my telephone directory would have been decades ago. Who, when and why they are accessed is largely unknown, except through a survey like this. Yet each year, the most frequent inspection of observations from the FDA are related to investigations that were not conducted according to the protocol. What can we expect if retrieval of information from current documents is not so easy for sites? Archaic means of information retrieval just don’t cut it in our everyday lives, certainly not when we can reach for a world of knowledge 24/7 with the phone in our pocket. So, how can we justify not applying this same approach to the information in clinical trials? Simplifying jobs to be done for research staff To be effective, technology must focus on helping clinical trial sites to be more productive through simplifying, reducing friction and making things easier. I know this sounds obvious – design clinical trial software from the perspective of research sites. But I would venture to say that a lot of the technology out there has been designed by people who have never visited a research site and don’t really understand in practical reality what sites really need. We’ve seen it with most software over the years. Technology handed down from on high that doesn’t suit the jobs done by site staff typically has low adoption rates, it often adds complexity and increases workloads. Sites will only truly embrace technology because they love it. They will only love it if it makes their job easier and helps them do their job better. You might argue that many study portals can be accessed on smartphones. Sure, but in reality, small screens and PDFs are enemies. It’s against our very digital nature to scroll through a document when we are so conditioned to ask a question and get an answer. Besides, when was the last time – if ever – you ran a search in a PDF on your smartphone? I’m not even sure how to do it. The reality is that sponsors and CROs continue to operate in an apparent “safe zone” – one biased towards risk mitigation rather than task optimization. Paper and online portals appear superficially “safe” from an audit perspective. And we’ve always done it this way. But at what cost? If the paper protocol is not stored where participants are seen, as reported in the Tufts CSDD study results, then what is the cost of not having the right answer right there, to answer a question on eligibility? As an investigator, how good is it to have a paper protocol in my office or an online portal when a patient phones me at 8pm while I’m at a ball game to ask me how to handle a possible toxicity? Giving a voice to research staff Sites need to be seen more as crucial stakeholders rather than servants of trials. It’s time that we shine a light on those technology solutions that work well for sponsors and CROs but complicate life in the field. Online portals are fine in theory; a secure repository for documents. Perfect – if you don’t actually need to access the documents in a hurry. And when it comes to communicating changes, then email is the obvious safe choice. We see from the study results that only a few respondents find out about protocol amendments from updates pushed out in the sponsor/CRO portal. This compares with the majority who say they receive updates via email. But we know all about the tsunami of emails we get daily, and in spite of best intentions how many emails are put in the “get to you later” category. A lot of time and effort is spent in protocol design and amendment. Protocols are getting steadily more complicated. Why then is access to the protocol so outdated and inconvenient? It really makes no sense. We need to stop thinking that throwing protocols over the wall to sites is good enough. It is not. We hope the results of this Tufts CSDD-Teckro research ignite a conversation about the information needs of site staff – many of whom are trying to conduct clinical research in addition to standard clinical care. And sadly, because it is so difficult, half will never do another trial after their first one. You can access the full Tufts report here and the companion Teckro analysis here.    
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Jul 22, 2020
5 Years of Teckro: We’ve Come a Long Way, But We’re Just Getting Started
I’ve often heard people describe starting a new company as being so hard and the challenges so great, that it is something you really have to love to persevere and succeed. Everything is stacked against you – if you considered the odds, you would never start a company. It reminds me of an article penned by the late actor Richard Harris when he wrote, “How do you explain a love affair? It belongs to the heart, not the head, something to be embraced or spurned – there can be no middle ground.” As entrepreneurs, we accept the challenge and dive head-first in. When we started Teckro, we had a bit of an advantage in that it was our second technology start-up. The first company, Firecrest Clinical, beat the odds as we successfully operated for a decade. Then, ICON acquired the company in 2011, and we stayed on as part of the ICON leadership for a couple of years. I can’t say we started Firecrest with a master plan or that it was intentionally the goal to sell the company to a CRO. But that experience as part of a global CRO gave me a deeper appreciation for just how broken the clinical trial process really was. There had to be a better way – a challenge we whole-heartedly embraced. Balancing Optimism with Uncertainty   There needs to be a degree of optimism to start a new company. In starting Teckro, we believed in a better way for clinical research so that drugs could come to market safer, faster, and more efficiently. At the same time, there is also a degree of uncertainty in getting a new company off the ground. Some of the factors are relatively within your control, such as designing your management team, hiring your first employees, and building your first product. Yet, the pandemic of 2020 – which isn’t something any of us would have thought of in 2015 – brings a new level of uncertainty. Whether a global health crisis or economic downturns, start-ups need a solid foundation to weather these storms. If there is anything certain for entrepreneurs, it is that these storms will come. It is how you prepare that matters. Any company starting out needs to have a purpose and then justify to prospective customers, investors, employees and the market in general why you exist. It’s finding that business problem and then delivering a product or service to solve the issue. It’s painting a vision that others buy into about what the future could be like if there were a different way of doing things. For us, it was a vision that clinical trials needed to be simpler, more accessible and transparent. How do you measure whether a vision resonates? I think we can look at the people from the industry on a journey with us, including hundreds of study teams from major pharma companies and thousands of research staff around the world. There are also our employees, coming from a mix of clinical research and software backgrounds who want to work for us. Validation that we are going in the right direction comes from the champions within our customers who tell us they can’t run a trial without Teckro. Looking around the Corner For all we’ve accomplished in the past five years, there is still much to do. Any CEO who isn’t looking around the corner isn’t doing his or her job. But as I’ve learned in my career, great things happen by surrounding yourself with great people. To that end, I am pleased that Amanda Buckley is the newest person to join our leadership team as Chief Operating Officer. Amanda brings depth of knowledge in both the pharma industry as well as software best practices. I’ll let Amanda say her hello in her own words with a video she prepared – those of you who know Amanda know she isn’t shy! Five years is a milestone that we are all proud of. Yet, it’s a bit retrospective. With momentum behind us, it’s now time to look forward to the next five years and the great things still to come from Teckro. Never taking the odds for granted, it will be with the same level of passion, creativity and sense of urgency to help our customers deliver drugs that improve the quality of life and ease suffering for millions of people around the world. Videos from Amanda, Gary and thoughts from our employees on Teckro’s 5-year anniversary are also available on a dedicated milestone web page.
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Jul 03, 2020
No One Left Behind: Our Vision of Clinical Trial Accessibility
I’d like to take a moment to shine a humanistic light on clinical research. Good Clinical Practice sets clear standards to protect the “rights, safety and well-being of trial subjects” and ensure data quality. But the description as “trial subjects” misses the human element from the people participating in clinical research. They are mothers, fathers, sisters, brothers, sons and daughters…. Their lives and that of their families may be altered, most likely more difficult, because of their illness. Participating in a clinical trial may improve their quality of life, possibly even prolonging life. Now, let’s put a “face” to the people who seek out clinical research. If we looked at participants in clinical trials today, we would see that they generally don’t represent society, either in the composition of ethnicity or gender. And more concerning, the patients don’t necessarily represent the intended beneficiaries for the treatment being investigated.   What if we consider other characteristics of the people who could participate in clinical trials? For example, what is their level of education? What is the literacy rate? How many are hourly wage earners who don’t receive sick pay? How many have adequate – if any – medical insurance? How many live in rural or remote areas with limited medical facilities? "If we looked at participants in clinical trials today, we would see that they generally don’t represent society, either in the composition of ethnicity or gender." It is against this backdrop that we ask: how can clinical trials be more accessible to more people? This led to our recent webinar "No One Left Behind: Addressing Clinical Trial Access and Issues Blocking Physician Participation.” We oriented this session from the perspective that making clinical trials more accessible to more physicians opens opportunities to build awareness and trust among a broader patient population. In perhaps the most engaging – and entertaining – panel discussion of my career, I had the privilege to moderate a discussion with a distinguished group: Ken Getz of the Tufts Center for the Study of Drug Development (CSDD), who is a leading industry expert in clinical research trends Cassandra Smith of Janssen R&D, who is a thought leader in clinical trial diversity and inclusion Brendan Buckley, Teckro Chief Medical Officer, who is an advocate for the site perspective as an investigator/physician himself I won’t give everything away, but here are a few highlights of each presenter: Cassandra presented the case for more awareness of racial diversity in clinical trials, citing research that indicates Blacks, Asians and Latinos are underrepresented in clinical trials, making up only 24% of the participants in key clinical trials over the span of a decade. Drawing on a wealth of Tufts CSDD research, Ken painted a picture of the increased complexity of clinical trials, with 86% more endpoints and 183% increase in overall protocol data over the last 10 years. And Brendan shared his perspectives on the ethical considerations, as well as the scientific perspective that a more diverse population will improve research on how different ethnic groups may react to a given treatment. The panelists then debated a few topics in a free-form discussion: How does improving access to trials increase diversity? How can sponsors manage the potential risk associated with new research sites and/or new investigators? Given protocol complexities, how can we reduce the burden on investigative sites? How can research staff and investigators get away from referring to paper copies of the protocol or PDFs locked on their desktop computers? What will the impact of COVID-19 be on future protocol execution? As part of Teckro’s ongoing focus on clinical trial accessibility, we sponsored this webinar as a way to be a champion for those who can’t be champions for themselves. With heightened awareness of clinical research and the disproportionate impacts of COVID-19 on minority populations, now is as good a time as any for the industry to take a new approach to clinical trial participation. You can access the webinar recording in our resources center. We also published an FAQ for physicians who may consider becoming a clinical trial investigator. And we published a solution perspective on how Teckro contributes to making clinical trials more accessible.
Blog
Jun 03, 2020
Best Practices to Improve Oncology Clinical Trials: Similar Challenges for Different Sponsors
There is the old adage that the customer is always right. And to a degree that is true. But when you are trying to challenge the status quo as we are with Teckro – the way things have always been done isn’t necessarily the way they should be done. But change is not without lumps and bumps along the way. It is in my capacity as a customer success manager that I can help ease teething problems for new study teams and accelerate success for our sponsors by sharing best practices we’ve learned along the way. It is always reassuring to study teams that problems they face are problems we’ve seen and managed for other sponsors. And let’s face it, the problems with clinical trial operations are big but not insurmountable. By thinking differently, sponsors have the opportunity to make clinical trials safer, more efficient, and more effective. There is no sweeter thing in my customer success manager role than helping a sponsor achieve meaningful business results from Teckro. Solving problems in pharma comes down to changes with people and process, aided by technology. But it also requires a mindshift, which is where in my role in customer success comes in, we are helping to challenge traditional approaches to show there is a better way. "By thinking differently, sponsors have the opportunity to make clinical trials safer, more efficient, and more effective." I recently participated in a panel discussion during the Outsourcing in Clinical Trials virtual conference (of course socially distanced from my fellow presenters), and I highlighted a few categories of challenges that sponsors face when it comes to cancer trials: Keeping sites and patients engaged, especially for long studies ​ Helping research staff properly execute complex protocols ​ Protecting patient safety, particularly toxicity management This list is of course not necessarily unique to cancer, but it gave me a good platform to highlight best practices for how sponsors can approach clinical trial challenges in a way that helps all stakeholders. That’s in contrast to other software that satisfies some study stakeholders but causes others (namely sites) frustration. The example I used in the presentation was a 10-year oncology study with a large number of sites and about 4,500 patients enrolled. Keeping sites and patients engaged​. When we looked at engagement, this was a big problem for both site staff and patients. Given the study duration, there was a high rate of turnover for both CRAs and site staff. Additionally, patient visits became less regular as the trial progressed – typically every six months or so. There was a huge issue and a real concern to keep patients engaged for 10 years, especially for patients whose health outcomes were not improving. Helping research staff properly execute complex protocols. Study design complexity, particularly visit schedules, was the second area we helped the sponsor to address. Oncology trials typically have many visits​ and a very detailed list of assessments or procedures for each visit​. Add to this, there are usually a larger number of protocol amendments that include changes to visit procedures.​ For this particular sponsor, there were 6 protocol amendments in just over two years. Not surprising, sites resorted to creating cheat sheets for visits. The question was how to make it easier for research staff to execute the trial based on the current protocol. Protecting patient safety. The third challenge I discussed, which is one of the most severe on patients, was related to toxicity and safety management. The study team worried about only being reactive​ and finding out about issues after they happened​. We worked with them to gain visibility so they could potentially pre-empt AEs and SAEs​ and proactively guide site staff on how to address issues. Connecting Stakeholders, Increasing Visibility At the end of the day, it’s about visibility. We see it time and again where sponsors, monitors and sites all feel disconnected from each other. In reality, clinical trial success relies on connecting all of these stakeholders for the entire duration of a trial. Of course, a lot of emphasis is put on the initial stages and patient recruitment, but the communication and trial guidance needs to be a steady flow throughout a trial. In my customer success manager role at Teckro, I help connect these dots with proven best practices, enabled by our technology. And while the customer is always right – we are showing them a better way to move their trials into the digital age, especially now with social distancing and other COVID-19 challenges. You can view the recording of the OCT presentation on our OCT resource page. I’d love to hear from you on your thoughts on best practices – you can email me at connectwithrita@teckro.com.
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May 20, 2020
Digitalization Will Improve Clinical Trial Data, a Perspective from Biostatistician Victoria Cooley
In honor of Clinical Trials Day 2020, guest blogger and biostatistician Victoria Cooley shares her perspective on clinical trial data quality and the opportunities for improvement with digitalization. From my first undergraduate course in biostatistics, I knew I wanted to pursue a career as a biostatistician. Eager to combine my passions for math and medicine, I enrolled in a graduate program for biostatistics at Columbia University. One of my first courses was an introduction to randomized clinical trials. Learning about the design and statistical aspects of clinical trials fascinated me. After all, this particular study design was considered to be the “gold standard” in research. Meaning that if properly designed, balance on baseline covariates could be achieved, eliminating the need to adjust for such confounders in the multivariable modeling phase or to have to explore other adjustment techniques. We even designed a mock phase II trial during the course. Looking back, I realize I should have included a section about the instruction of proper data collection and randomization techniques. However, no additional lectures or classroom time would prepare me for the design and analysis complexities that I would encounter in the real world as a biostatistician. Since starting my career, I have worked on the planning and analysis of a variety of observational studies as well as some clinical trials. One trial in particular stands out to me, for it challenged several of the points that I had learned in my graduate course. When the data were first sent to me, I was notified that I would need to manually exclude several patients as they were later identified as violating the randomization parameters. Some patients were randomized to the different study groups but violated the study protocol and others were screened but never randomized. From a statistician’s point of view, I could not believe that I had to discard valuable patient data from the primary analysis. As a patient myself, I would be disheartened if I found out that months or years of the collection of my data resulted in information that could not be used in the way it was intended. "From a statistician’s point of view, I could not believe that I had to discard valuable patient data from the primary analysis." As I learned more about the trial, it seemed several people had been working on the data collection and much of the data were collected on paper forms. Many papers were misplaced, and the data were collected in a scattered, disorganized manner. In order to pull the necessary data into a format for me to analyze, the investigator spent several weeks manually creating a database with all the necessary information, alongside performing their regular clinical duties. Even then, when the data were sent to me, I spent many hours cleaning and transforming the data into a format that I could work with. Despite the fact that this study was documented as a randomized clinical trial, the investigator and I still had to consider the adjustment of certain baseline characteristics in the multivariable models as we were doubtful that balance was achieved between the study groups. To complicate matters further, we were faced with a considerable amount of missing data, largely due to paper forms being misplaced or values not being entered as desired. While missing data is practically inevitable, the reason perplexed me. If the data were recorded in a different format other than on paper, perhaps digitally recorded via computer or smartphone device, it is likely that the missing data would have been far less than we observed. This is not to say that the missing data could have been eliminated completely (as some variables are inherently prone to missingness or lack of subject response), but the digitization of the recording of this data could have greatly helped. Essentially less of the data would have been “lost in translation” from paper to computer. Moreover, when data are automatically taken or recorded in real time, there are less opportunities for human data entry errors (as is the case with reading and entering information off of paper forms). The accessibility of the study protocol is another factor that could have greatly improved the success of this trial. Given that so many different people were at one point or another working on this trial, I can imagine that not everyone was completely familiar with the protocol. If the protocol were housed in some central, digital area, would the randomization parameters still have been violated? While I cannot answer this question with 100% confidence (there is always some form of doubt in statistics), I do believe that many more patients would have been randomized correctly. “If the protocol were housed in some central, digital area, would the randomization parameters still have been violated?” In case you were wondering, the trial did produce some interesting results, and after several hours of careful consideration, analysis, and discussion, our abstract was accepted at a well-regarded conference. Overall, I can say my experience working on this trial was extremely eye-opening and thought-provoking. While I am grateful for this learning experience of working on a challenging study, I do hope that clinical trials continue to become increasingly digitized in the years to come. The amount of time, effort, and money that could be saved will be worthwhile, as this will allow for more focus to be placed on saving and improving the lives of millions of people worldwide. You can connect with Victoria on LinkedIn. About Victoria Cooley Victoria Cooley is a research biostatistician in the Division of Biostatistics and Epidemiology in the Department of Population Health Sciences at Weill Cornell Medicine in New York City. She holds an M.S. in biostatistics from Columbia University, and B.S. in health science from Springfield College. Before joining Weill Cornell Medicine, Victoria worked on the analysis of clinical, molecular genetics, and biochemical data from the North American Mitochondrial Disease Consortium Registry at Columbia University Medical Center. Victoria engages in short-term and long-term biostatistical consultations for investigators. A large part of her work centers on her support to researchers through the Clinical and Translational Science Center, where she provides data analysis and prepares reports, methods sections, and analysis plans for abstracts, manuscripts, and grants. She also works closely with the Departments of Pediatrics, Urology, and the Joint Clinical Trials Office and assists in teaching biostatistical methodology to medical residents, fellows, and other research staff.
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May 15, 2020
FDA, EMA Update COVID-19 Guidance for Clinical Trial Continuity
The impact of COVID-19 on non-related clinical trials is complex and poses significant challenges for sponsors, investigators, monitors and patients. With the scale of disruptions (e.g. self-isolation, travel bans) as well as the implications of social distancing, regulators are providing guidance to steer decisions that protect patient safety and preserve data integrity. Given the volatility of the situation, both the FDA and the European Medicines Agency (EMA) in conjunction with working groups from the European Commission and the national Heads of Medicines Agency (HMA) issued revised guidance from their original recommendations in late March. In particular, the FDA included a set of questions and answers that cover a wide variety of topics including: Factors sponsors should use in deciding whether to suspend or continue ongoing studies and/or initiate a new study Alternative means of distribution of investigational products. Considerations in selecting alternative laboratories or imaging centers. Remote monitoring and applying a risk-based approach to prioritize sites for remote monitoring. Usage of video conferencing between study personnel and patients.
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May 08, 2020
World Ovarian Cancer Day May 8, 2020: Why Modernizing Ovarian Cancer Clinical Trials Is More Important Than Ever
Ovarian cancer has the lowest survival rate of all gynecological cancers and is characterized by its late stage diagnosis and “hidden” symptoms. By the time it is found, it has often spread, which is why it’s so important to tackle this devastating disease on all fronts. Today, May 8, is World Ovarian Cancer Day, which brings together ovarian cancer organizations around the globe to show support for the roughly 300,000 women diagnosed each year. Of this number, around 140,000 will sadly die. And by 2040, the number of women diagnosed annually will rise to 434,184. By this estimate, the number of women dying each year will increase to 293,039. Sobering statistics to say the least. COVID-19 and ovarian cancer diagnosis The problem is that these figures don’t take into account the impact of COVID-19 on cancer treatments. Right now, doctors across the world are experiencing enormous challenges when it comes to diagnosing cancer as well as treating patients. Many patients suffering with symptoms are likely staying at home. At the start of the pandemic, many governments called on physicians to halt nonessential procedures. What many people didn’t realize was that this included many cancer surgeries. So, as it stands, many women with ovarian cancer could be missing out on biopsies, scans and visits to their doctors. And because ovarian cancer is so hard to diagnose in the first place, there will be more women who will ignore early signs such as bloating and loss of appetite because they will think that physicians are not available to see them. A chance to modernize clinical trials In periods of emergency, great technological progress is often made because time is of the essence. We have seen how fast the world has got used to working from home - a development that would have been unthinkable just three months ago. The pandemic sweeping the globe has shown that people quickly adapt, and the clinical trial industry is no different. Technology solutions such as Teckro have been adopted to streamline the clinical trials management process. This is good news because technology has a role to play in improving trial efficiency, protecting patient safety and preserving data integrity – ultimately getting treatments to market faster. For patients suffering from cancers that are difficult to diagnose and/or prone to relapses, it only makes sense to remove every barrier with how clinical trials are run to focus on finding a cure. Here are two key ways to help lower the ovarian cancer fatality rate through modernizing clinical trial management: Improve communication among research staff, monitors and sponsors. By connecting stakeholders, it means everyone has the most current study information. Whether specific details in the protocol or providing clarifications for a site-specific question, collaboration and real-time communication are essential. As they say, information is power. In clinical trials, information is the key to trial safety and data integrity. We have found that when research site staff have access to immediate, accurate answers, there are fewer errors and the right patients are recruited faster. For example, in our analysis of several studies with a Top 10 sponsor, we found that sites searching with Teckro randomized on average 55% more patients compared with sites not on Teckro. And two oncology trials with a Top 10 sponsor reported 55% fewer deviations per patient randomized for sites searching with Teckro compared with those not. Increase the number of women taking part in clinical trials. The Every Woman Study Summary Report from 2018 that surveyed 1500 women worldwide, showed that fewer than one in four women were asked about joining a clinical trial. But, just 2.7% of women said that they were not interested in taking part in future clinical trials, with eight in 10 women saying they would be willing to travel to another hospital to take part in a trial. The results clearly showed that the desire is there and the opportunity more often than not, is not. By making clinical trials simpler, more accessible and more transparent, our hope is that more investigators will want to run trials and that will in turn make trials more accessible to more patients – including women. Ovarian cancer is a devastating disease with more than 80% of ovarian cancer patients experiencing a relapse and over half dying in less than five years post-diagnosis. The survival rate is well below that of other cancers affecting women, like breast cancer which has a 90% five-year survival rate if caught early. There’s no doubt that at the moment the long-term projections look bleak for ovarian cancer. However, it doesn’t have to be this way. This year, World Ovarian Cancer Day falls during a time when COVID-19 has also highlighted the vulnerability of cancer patients when resources are scarce. This offers an opportunity to seize the chance to modernize clinical trials to make sure that effective treatments can be discovered and that ovarian cancer patients can access them and don’t slip through the cracks during the eligibility process. Want to learn more about how Teckro is helping to accelerate cancer trials? Join our presentation on May 27 at 16:30 during the Outsourcing in Clinical Trials Virtual Conference. More details can be found on our events page.  
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Apr 28, 2020
Product Development - Ant Steps or Giant Leaps?
There is something intrinsically romantic and inspiring when a remarkable individual, or team, have a sudden moment of magical genius and creativity, resulting in a new technical invention to improve the current “best in class.” These stories are memorable and make great Hollywood movie scripts. But in reality, product development is quite often very different, something Kevin Ashton discusses in his book How to Fly a Horse. Rather than through a eureka moment of inspiration, new creations, inventions or discoveries are the result of many small, incremental steps. Continuous, and sometimes endless, loops of “try-assess-adjust” activities are undertaken by common individuals who have abundant grit to persist despite missteps along the way. There are many thought-provoking points in Ashton’s classic. However, the timeless idea of delivering great innovative products as a sequence of continuous “ant-size” iterations rather than the result of infrequent giant leaps is even more relevant today in the world affected by coronavirus – the black swan of 2020. The word “continuous” is frequently used in business context. Quality managers discuss continuous improvement process. Product and software managers explore continuous product delivery. And more technically-minded folks consider continuous integration as one of the “must-have” engineering practices. Continuous improvement is a mindset. It is any effort to improve products, services or processes in an incremental fashion or as a “breakthrough.” It originated in Japan after World War II and is how Toyota expanded from a small local car-maker to the largest automobile manufacturer in the world. Today, the concept of continuous improvement widely applies to business practices, including the International Organization for Standardization of a Quality Management System (ISO 9001:2015) and an Information Security Management System (ISO 27001:2005). Continuous improvement ideas are also at the core of agile software development. So, how do we apply “ant steps” innovation to product development in the highly regulated clinical trial market? There is no silver bullet or “one size fits all” approach, but there are a few universal ideas to stay nimble and deliver business value via continuous product delivery. Document your software development lifecycle (SDLC). This should encompass all essential phases for software delivery, from initial discovery to detailed user requirements through to development, testing and deployment. Scrum framework is a good starting point, but it needs to be applied appropriately and customized to support your own specific business needs, team skills and experience. For example, if your software product has regulatory implications and computer system validation is required, you may need to accommodate validation activities from the beginning into your sprint cycle. Focus improvements on the big wins. Starting with a well thought out and relevant SDLC is important, but what is even more important is to keep your continuous improvement hat on at all times. Consider that you are only as good as your last product delivery cycle. Think of your SDLC as a mini management system, ensuring that you have adequate performance metrics so you can spend your improvement efforts on the right areas – the big wins. Adopt an agile mindset. People are the lifeblood of any organization. The Agile Manifesto acknowledges this in the first value – “Individuals and interactions over processes and tools.” A highly motivated team equipped with basic tools or informal, high-level processes is more likely to outperform a demotivated team with the best tools or detailed procedures. You will need to hire for and constantly nurture your organizational agile mindset to succeed in continuous delivery cycles. Measure your progress. Mid- and long-term, strategic product roadmap planning is critical. Without a plan in place, you may become very efficient in churning product enhancements that contribute very little business value or don’t address real user needs. And, along the way, you may lose sight of what your product needs to stay competitive. At regular intervals, you need to measure business value against financial metrics, user feedback, and alignment with your roadmap. Ideally, this analysis should be a quarterly exercise and include all C-level and founders if they are still actively involved in the business. Learn early and continuously. Common wisdom is to deliver a minimal viable product (MVP) as quickly as possible to obtain real user feedback and ensure the “right” product is being built. A team practicing Scrum may assign MVP features to sprints and deliver an internal release at the end of each sprint. However, these internal releases are not always treated with the same level of rigor as production releases. The result is that key learnings may only be acquired very late when the first release to production takes place. Alistair Cockburn, one of the initial authors of the Agile Manifesto, describes it as “Big-Bang Design.” This approach is riddled with problems and risks, including descoped MVPs being released behind schedule. Continuous product development is a mindset – it’s a journey and not a destination. It is also a multi-dimensional topic. For example, I haven’t even addressed the topic of good engineering practices, which are critical to continuous product delivery. While COVID-19 has disrupted everyone at some level, it shouldn’t be a roadblock to continuous product development. Rather, it is a time to find strength – both as individuals and teams – to overcome obstacles. This applies to software development and any other passion we have in life. For example, a few days ago, I had the opportunity to listen to Patrick Mouratoglou, a world-renowned tennis coach, speaking to students of his tennis academy on a video call. He had a very powerful message to his students – some of whom are likely to be future professional athletes. Despite lockdown, Patrick told them that professional players stick to their daily routine as much as possible to continue to make ant-size improvements in their game. Whether tennis, software development or something else, continual improvement comes with thousands of ant steps. I would like to hear your thoughts. Please email me at connectwithjacek@teckro.com.
Blog
Apr 16, 2020
COVID-19: In This Brave New World It’s Time to Overcome Fear of Clinical Trial Technology
It's not an exaggeration to say that the pharma industry must operate at a pace that it’s never seen before to tame or even cure COVID-19. As billions of people live in some kind of lockdown, countries, businesses, and society in general cannot endure this kind of restriction indefinitely. And healthcare services – already stretched – cannot continue to operate under this heavy load. While we are resilient in the face of previously unthinkable situations, there needs to be a light at the end of the tunnel. Government leaders have a heavy burden to make the right decision of when to loosen or lift restrictions. And so, it is now that the pharma industry must step up to swiftly find a way to help us through COVID-19 and protect us in the future. In the “old world” -- before COVID-19 – it could take a decade for a new vaccine to come to market. Now, we are all counting on the industry to deliver treatment in months – something unthinkable before the year 2020. Traditional clinical trial timetables must be accelerated – safely accelerated – as the world waits for a solution. It’s with this speed that clinical trial technology can help pharma to truly transform. And it’s for this reason that Teckro is already supporting 5 COVID-19 trials with more on the horizon as sponsors race to safely set up COVID-19 trials. A stark reality has become evident: namely that clinical trial technology is not a “nice to have” but a “must have.” In previous articles I’ve discussed the paper protocol and how both inaccessibility and inconvenience of paper places an unnecessary burden on site staff and physicians. Before, during and after clinical trials, many questions need to be answered, such as which patients are eligible, which trials are suitable, how to manage a toxicity that arises, etc. The current environment creates all sorts of new dilemmas, meaning that it’s more important than ever that those involved use clinical trial technology. Here’s why: Rethinking Clinical Trials Social distancing isn’t exactly compatible with clinical trials. This is where rethinking how to best conduct the trials comes in. The issue is that there’s a fear of the unknown when it comes to conducting trials from a virtual or decentrialized setting. Data concerns, privacy worries and a very human suspicion of change have all been factors blocking change. Well, it could be that soon there’ll no longer be a choice. It may be difficult at first, but ultimately rethinking how clinical trial technology can open the door for greater diversity, with more underrepresented populations taking part. The time of travel to sites meant that those from more remote communities and women (who often have childcare responsibilities as well) haven’t been able to participate as much in the past. If this period of global standstill could be used to test out decentrialized clinical trials, they could well become commonplace in the future. This is good news for society because decentrialized clinical trials means more convenience and more diversity, which will ensure better drug development outcomes. Real-time Information The clinical trial protocol and other study documents when accessed through binders of paper are generally nowhere near the patient. If there is an adverse event and people are working from home, interaction costs could increase as no one will know how to access the information they need or even who has it! Real time communication can help to streamline discussions between site staff, CRAs and Sponsors, as well as help physicians make quick decisions. In the months ahead, real time communication will not be a luxury but a necessity to guide clinical trial safety and data integrity. In today’s reality, clinical trial technology is the only reasonable means to achieve real-time and yet still compliant communication. No Need to Travel! The pandemic has made us all rethink our priorities and discover what’s really necessary in the world of work. Some meetings and travel have proved to be superfluous, with videoconferencing doing the job just as well. The way clinical trials are structured, there are monitors across multiple sites, with each one potentially having a study coordinator trying to reach the CRA to interpret something in the protocol. The problem is that the CRA could well be travelling to the next site and unable to give the information needed, slowing down the whole communication process and potentially hindering the sites. In turn, Sponsors have limited real-time visibility into the clinical trials especially at the site level. By removing this friction, Sponsors can access site-level information to address issues hindering sites. As travel isn’t currently an option for anyone at the moment, it’s a chance to test clinical trial technology that allows staff to communicate in real time. Now Is the Time to Overcome Fear of Clinical Trial Technology There’s now a globally disrupted workforce and the clinical trial model needs to keep pace with this changing reality. After all, who knows what type of world will emerge in the next few years? The need for transparency, connectivity and mobile access to the protocol anytime, anywhere for all research staff is a necessity. And now, more than ever, the industry must get over the fear of clinical trial technology to adapt to the new reality. Do you have any thoughts on how clinical trials can embrace technology? As always, I'd love to hear from you. Please send your thoughts to connectwithgary@teckro.com
Blog
Apr 01, 2020
Taking a Risk-Based Strategy Further: It’s Time to Rethink Clinical Trial Monitoring
There probably isn’t a person on this planet that isn’t closely watching the current coronavirus (COVID-19) pandemic. Like everyone, I am concerned with the health of my family, our employees, our customers, and generally the people of the world impacted by this virus. But it is in the face of such adversity that we need to ask how we can adapt for whatever uncertainty the future holds. If anything is certain, it is that there will be circumstances that will disrupt business as usual. Disruption happens. Businesses need to be prepared for these disruptions and many have business continuity strategies currently in place. But, who could have predicted a global pandemic which has impacted every business sector and supply chain? Answer: No one. Clinical trials are vital for evaluating and advancing medical and patient care. Today’s current situation is impacting how these clinical trials can continue operating safely and efficiently. Functions impacted include – but are not limited to – supply chain, patient safety, data integrity, patient retention, investigational product management, clinical trial monitoring and trial management in general. All areas in clinical trial management have been impacted but specific to clinical trial monitoring, the current model must be modified to ensure that the clinical trials can continue to operate. Specifically, clinical trial monitoring must be adapted to ensure a risk-based strategy is implemented to manage all study-related risks but also to ensure that patient safety is addressed and that data integrity is maintained. Here are a few observations in the current clinical trial monitoring model that need to be reconsidered in light of our current situation: Clinical trial monitoring is primarily based on physical movement of people. CRAs are moving from site to site. You only need a few flight disruptions and cancellations to cause issues. And now, CRAs are likely not able to perform site visits due the coronavirus restrictions. It can be retrospective and reactive. CRAs can only be at one place at a time. As a result, there is no real-time detection of site related issues. It might not be until the next site visit weeks later that potential risks are identified. It can separate research staff and critical medical/scientific knowledge. In most instances, the CRAs are the intermediaries between research staff and trial management and medical monitors. This “switchboard” means providing study related answers can take precious time that no one can afford. In the current environment, quick and real-time communication is essential to ensure continuity of care. It is dependent on paper. This requires that site staff physically refer to the regulatory binder for protocol-specific information. How will regulatory documents be accessed for verification if CRAs or site staff are not physically located on site? Specifically related to the protocol for quick reference, how will sites be ensured that they are utilizing the most current version available? In consideration of the current circumstances and to bring us forward in confronting the current monitoring limitations, it is time to rethink the approach to monitoring and bring it into the 21st Century. We can help. Here are some targeted solutions that I think can realistically improve the effectiveness of monitoring and address the inevitability of disruptions that will happen in the future: Rely less on face-to-face interactions. Utilizing a risk-based approach, CRAs will only be on-site to address any critical milestones and will have more time and bandwidth to assess critical to quality endpoints in-house rather than onsite. Streamline communication with research sites. CRAs and clinical trial management should have a proactive, simple and streamlined way to provide real-time updates rather than generic or passive means (e.g. in person visits, email, newsletters, etc.). This includes proactive information on study updates as well as answers to time sensitive questions. Measure the impact of the communication. Hope isn’t a strategy. When it comes to knowing whether study-related information has been effectively delivered and received and being actioned by the target audience, there is no room for guessing whether the PI or study coordinator got the message. Respond quickly to data that shows potential risk to the study. With less physical travel, CRAs can review data remotely in real time and respond to critical data points that are negatively trending and represent a risk to the study. In this model, we can further improve the quality of the trials and better protect patient safety. Have immediate access to the current protocol any time. Research staff and CRAs always need access to the right version of the protocol at their fingertips. This isn’t always practical or efficient with paper or PDFs in a portal. But real-time access to the right version at the right time is vital. Out of any crisis, there is an opportunity to reflect on how we can better prepare for the future. We’ve seen how important it is to continually evaluate new ways of operating in light of this current situation. With the management of clinical trials, there are numerous strategies to be considered. Specific to monitoring clinical trials, it’s time to rethink the current model. Fortunately, with the smart use of technology, it is not out of reach to make changes in how clinical trials are monitored and we are well-positioned to rise up and meet the challenges imposed by COVID-19 and its impact to the management of clinical trials. What do you think about modernizing clinical trial monitoring? Please send me your thoughts at connectwithandrea@teckro.com
Blog
Mar 24, 2020
A Letter from Our CEO: Supporting Your Clinical Trials Without Interruption During COVID-19 Crisis
I would like to assure all of our clients that Teckro is well prepared to support your clinical trials, in spite of the COVID-19 pandemic. I understand that you are challenged with restricted movement of CRAs and patients, and that research staff are under pressure to treat those afflicted with the coronavirus (COVID-19). You can be rest assured that Teckro will do everything in our power to support your trials without interruption. Whether you have protocol amendments, need to change user access, or have users who need support from our helpdesk, our staff will be available. At Teckro, we have reviewed our existing pandemic plan, and we are updating as necessary. Like everyone, we are closely monitoring advice from local health and government authorities in all of the countries where we have staff. We have a dedicated task force that meets daily to plan and assign actions and to keep senior leadership current on any developments.   As with many businesses, we have taken the precaution to suspend all non-essential travel. Our global staff are working remotely from their homes until April 10, at which point we will reassess the situation. To preserve business continuity, we have core teams identified as well as second-in-command personnel for major functions, should the need arise.  From a product standpoint, Teckro software is built on a hybrid infrastructure between top-tier Equinix data center and AWS. Our Equinix-based infrastructure is fully redundant on each layer starting from power, connectivity, and throughout the application and database layers. Our AWS-based infrastructure is deployed across three availability zones for high redundancy. Teckro has robust DR procedures to allow a move from Equinix to AWS as required, which is tested on a regular basis. This is a global crisis that knows no boundaries of nations, races or beliefs. United as one, we will overcome this situation. I hope that you, your families and your employees stay in good health. If there is anything I or my staff can do to help you at this time, please don’t hesitate to contact us. Best regards, Gary This letter was originally published on March 12 and has been revised on March 24. Updates will be published here as necessary to provide current, ongoing information for our customers and business partners.
Blog
Mar 08, 2020
International Women’s Day 2020: We Must Demand More Gender Diversity in Clinical Trials
In the first of our series on clinical trials and diversity, our CEO Gary Hughes discussed how ethnic populations are underrepresented in trials, leading to a lack of knowledge around how drugs affect patient groups viewed as outside the “norm” (today still primarily white and male).  On International Women’s Day I’d like to draw attention to that other neglected cohort: women. As roughly 50% of the population, we’re hardly in the minority, which is why it’s so shocking that women’s health is so under-researched.  Women’s lack of participation in clinical trials is not a new problem. A recent study from the Allen Institute for Artificial Intelligence in Seattle examined women’s participation in medical research over a quarter of a century, looking at 13,000 trials registered on clinicaltrials.net. While women made up 49% of all participants, when the data was analysed study by study, women were often still unrepresented. For many disease types, the ratio of females to males didn’t match the real-world gender split among patients. This included deadly conditions such as cardiovascular disease and chronic kidney disease. 
Blog
Feb 28, 2020
We Cannot Afford to Ignore the Lack of Ethnic Diversity in Clinical Trials
The importance of diversity in clinical trials cannot be emphasized enough – yet progress isn’t being made nearly as quickly as needed. Recent research shows that the levels of patients enrolling in a clinical trial as a first form of treatment for cancer in the US is just 0.1% and this is predominantly made up of White men with private insurance. A ProPublica analysis found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of Black patients were enrolled. Yet, African Americans make up 13.4% of the US population. Sadly, these statistics don’t surprise me. Ethnic groups have been underrepresented for as long as I can remember. This is a huge problem. Drugs can work differently depending on factors like sex or ethnicity, meaning people from different ethnic groups and genders may respond in hugely different ways to the same drug. But if there’s a lack of diversity in clinical trials, how will we ever know? Stand Up to Cancer Moves to Make Trials More Diverse Here at Teckro, our machine learning platform is used by more than 7,000 oncology sites worldwide and I recently wrote about Teckro’s goal to revolutionize clinical trials to help beat cancer on World Cancer Day. Therefore, I welcomed the news that Stand Up To Cancer (SU2C) have announced a ground-breaking new initiative to increase ethnic representation in clinical trials. All future SU2C-supported grant proposals will now be required to address how the research will consider ethnic diversity when it comes to recruiting and retaining patients. The move comes just a few months after the FDA announced a new focus on enhancing clinical trial diversity. These bold new developments force us in the industry to adapt, learn best practices and work to ensure the clinical trial population is a true representation of society. After all, diversity is crucial for safer, more effective medicines, so that researchers, regulatory bodies and patients are confident that a drug or therapy will reach the communities they’ll serve best. Here are a few more suggestions I have to help make clinical trials more ethnically diverse: Make participation easier. Currently time and travel commitments mean that taking part in trials is difficult for participants. By making trials more accessible, it will be easier to recruit from a wider variety of backgrounds. By using digital and virtual clinical trials, patients located further afield could be reached and the burden could be minimized by conducting some aspects of the trial remotely. Wearables, smartphones and tablets could also make participation more convenient. Build trust. For more ethnic communities to be engaged in clinical research, there needs to be improved relationship building and a better sense of partnership. Patients need to trust the research process, as well as the healthcare professionals involved and – it should go without saying - be treated with respect for their role in the trial. This can be achieved by having specific teams from local communities onsite to understand cultural sensitivities. As a result, more diverse clinical research communities will be built, leading to a more varied pool of participants. Improve awareness. Many potential participants don’t even know that clinical trials exist! The research community could change this by reaching out to local physicians to increase awareness of clinical trials. Resources could be provided to help them discuss the benefits with patients. In my previous blogs, I’ve mentioned how important it is to make the clinical trial process more convenient for physicians. And because physicians are typically short on time, they may not even be that knowledgeable about clinical trials themselves. Which brings me on to my final point… Increase education. Driving better understanding of clinical trials is an essential element when it comes to participation from a wider group. Providing proper education (using culturally appropriate materials) is a way to assist further understanding. And this goes beyond physicians handing out a few leaflets, ideally there would be strong local publicity campaigns – even nationwide conversations about the importance of ethnic diversity in clinical trials. Ambitious? Definitely. But a future of safer drugs, more efficient medication and lives saved, is one worth fighting for. Do you have any further thoughts on advancing clinical trial diversity? I’d like to hear them, please email me: connectwithgary@teckro.com.
Blog
Feb 04, 2020
World Cancer Day 2020: Progress Has Been Made - But We Can Do Better
World Cancer Day is a chance for global communities to unite, to show solidarity and pledge to work together to defeat this devastating disease. It’s also an opportunity to celebrate – we know more about cancer than ever before thanks to incredible breakthroughs in new medicines, advances in surgery and increasing scientific knowledge. The American Cancer Society has reported that cancer death rates in the United States alone fell 2.2% from 2016 to 2017 – that’s the largest single-year decline in cancer mortality ever reported. And cervical cancer could be eliminated by the end of this century, according to The Lancet, if cervical screening and HPV vaccination programs are scaled-up to 80% -100 % coverage over the next 50 years.  On one hand the decline can be linked to lifestyle changes, with smoking cessation contributing to the drop in the cancer mortality rate - lung cancer accounts for nearly one-quarter of all cancer deaths. But improved cancer detection tools such as new imaging technologies and less invasive surgical approaches have also played their roles. The official World Cancer Day site estimates that up to 3.7 million lives could be saved each year by mobilizing resources for prevention, early detection and treatment. Teckro’s Message on World Cancer Day, February 4, 2020  While we celebrate the breakthroughs made so far, the truth is that millions of people across the world will continue to die from cancer because new medicines are taking too long to get to market. Also, more than half of doctors who run their first clinical trials will never run another, meaning that patients’ access to trials are limited and therefore, so is the search for a cure. This is why our message on World Cancer Day 2020 is that we can do better. Much better. Clinical trials are stuck in another time, the burden on investigators and trial sites is increasing – which is quite extraordinary considering this technological era when we’re all so obsessed with speed and instant results! The cumbersome nature of the protocol puts physicians off participating and slows down progress when it comes to defeating serious diseases like cancer.  We’re proud that Teckro is leading the way in changing this reality. Our machine learning platform is currently being used to support more than 7,100 oncology research sites around the world. An impressive 77% percent of registered users are active on the platform ­– and it’s not required, so they are consciously choosing to use Teckro because the platform brings so much value to them.
Blog
Jan 28, 2020
Overcoming Fear of the Unknown: The Path to Virtual Clinical Trials
Recently, I attended a seminar on virtual clinical trials. I know, I know…another seminar to enlighten us on what’s new, upcoming, and trending. With benefits like reduced costs and saved time, virtual clinical trials seem appealing. So, why aren’t sponsor companies and clinical research organizations (CROs) running to implement them? Those of us who have worked in the pharma industry for quite some time understand that while new technology might sound promising, there are real challenges with its implementation. If we are being honest about why virtual clinical trials are not being implemented as quickly as you would expect, the truth – at least in part — is fear of the unknown. Let’s face it, trying to change years of clinical trial conduct is like turning the Titanic on a dime. Process changes, organizational mindset, regulatory requirements, data privacy concerns, and impacts on other internal systems are just a few reasons why virtual clinical trials haven’t taken off. So how do we challenge our current system and take that first step into this unknown space – or at the very least, dip our toes into the big scary pond that is virtual clinical trials? The bigger question in my mind is, can we as an industry afford not to? We only need to take a look at the current state of clinical research trials to see how broken they are. With an approximate 30% patient drop-out rate and 50% of sites not recruiting as per schedule, it’s clear we need to tackle the root causes for continuous trial delays. There is also a lack of trial diversity. Specifically, the women, elderly and individuals in rural populations who are woefully underrepresented. Throw in some additional barriers like patient mistrust making recruitment more difficult, and it’s not hard to see that we have a real problem. Given these glaring statistics, we need to ask how can virtual clinical trials improve the current state of the industry? There are instances where some are already dipping into the virtual clinical trial space, especially in late-phase trials. But we need a push to take the ultimate plunge within the Phase I-III space. That push is coming directly from the patients, and their voices are getting understandably louder. Let’s discuss removing these barriers to get into the virtual clinical trial game. Here are a few checklist suggestions to start the discussion: Take a holistic approach. Whatever technology is being considered must be harmonized across all devices. As an example, the smartphone plays an essential role. It can be used for patient engagement, medical reminders, phone/telemedicine options, patient eDiary, and follow-ups. Consider what data you need. An app alone can only solve one part of the problem. Data needs to be enabled within the app, which means the level of information captured is crucial. As an example, capture only what is vital for an endpoint of the study ­­– any additional information will complicate the study by requiring additional regulatory hurdles, incurring data reliability issues, data overload or resistance from patients and healthcare providers. Fit into the everyday life of the user. Technology should not be a burden for the patient or healthcare professional. For example, instead of having to manually track and enter data could the patient use a wearable device that would automatically and easily capture the required information? Plan for changes. Another consideration is to evaluate what would happen if there is a change in the technology itself. If there are routine software changes, will the data remain viable? Consider how this will be managed. Factor in compliance. Finally, compliance is key! Consider compliance with actually wearing the device or using the technology. Again, this needs to fit seamlessly into their day to day life. The good news is that sponsors and CROs don’t have to go it alone. There are existing resources out there that can offer assistance for evaluating new technology. And the FDA has existing guidance to help ensure the appropriate regulations are being followed. We are on the cusp of transforming how we conduct clinical trials. Yes, there are regulations and challenges, but even the FDA is on board and encouraging greater adoption of clinical tools. Our collective job now is to take the leap and be the innovative change agents that move the industry forward. Do you have any suggestions on how to improve industry adoption for modern technology like virtual clinical trials? Please email me at connectwithandrea@teckro.com.
Blog
Dec 18, 2019
The Secret to Clinical Trial Success: Unblocking Research Staff
There aren’t enough physicians in the world taking part in clinical trials. But what’s more troubling is that a large percentage of doctors who run their first clinical trial say they wouldn’t run a second one.  Physicians are the trusted advisor to patients. Without increased participation from them, it limits access to clinical trials for patients. Rather than trying to skirt the problem, we need to address core issues that limit why doctors don’t want to run clinical trials. Reducing Interaction Costs  Doctors generally have just a few minutes with each patient. This means they have a very short window to make critical decisions about the patient’s eligibility for a clinical trial. For larger research centers, this decision can be even more difficult if they are running several trials for different sponsors in the same disease area.  Given time pressures, logically speaking, it would make sense that doctors have quick and easy access to the information they need when they are with the patient.  Yet, access to the clinical trial protocol and other study documents today is primarily through binders of paper documents that are nowhere near the patient. Or, there may be electronic versions of the same documents that are hosted on a secure password-protected portal.  Neither approach is ideal for busy, time crunched research staff on the go. The reality is that high interaction costs – the time and effort to find answers – can limit trial success if it’s just too hard to find the information to make the right decisions.  Unblocking Research Sites Whether clarifying inclusion/exclusion criteria, managing a toxicity, or confirming the next steps from an adverse event, research staff will have questions that require input from experts. Sometimes the answers are time sensitive.  With so many channels – email, phone, text, chat – it’s hard to keep track for both CRAs and research staff. Email still seems to be the dominant channel, but it lacks any urgency for immediate questions.  Additionally, informing research staff of study or document changes is not straightforward as different sites may be on different versions of the protocol and located around the world. Newsletters are an effort to tackle some of the challenges, but that is still a generic, one-way broadcast. It is no surprise that communication is a common complaint among research staff. Without timely, accurate answers, sites are blocked. If sites are blocked, trials are blocked.   Considering the Research Site Viewpoint  Research staff have the best insights when it comes to patients. It is a wasted opportunity not giving them a voice with regards to things such as whether a trial should progress to the next phase or the viability of finding patients for a given study.  By asking for research site feedback, sponsors can gain valuable field-level intelligence that can influence trial success and future study design. Who better to give input than those who know the patients best?  Let’s not forget that investigators and research nurses are human. Asking for feedback has the potential for sponsors to foster better relationships with research staff. This in turn could make them the sponsor of choice and ensure that clinics want to manage their trials.  Giving Research Staff Confidence  It all comes down to confidence. Research staff need to have confidence they are making the best choices for their patients.  As the front line in any clinical trial, we need more doctors engaged. Giving them the tools they need to make informed decisions at each step could reduce friction for sites. And with more doctors participating, more patients will have the opportunity to participate in clinical trials.  This would be a win for everyone. Do you agree? Please let me know at connectwithgary@teckro.com.
Blog
Nov 19, 2019
The Trouble with Clinical Trials: Getting Rid of Zombies
New medicines are becoming increasingly complex to develop. As a result, clinical development is taking 25% longer and the chance of a new medicinal product getting market approval is half of what it was a decade ago. Much of this is reflected in the way clinical trials are performed, with a 10% annual increase in the number and variety of procedures required. Thus, the burden on investigators and trial sites is steadily becoming heavier. In most aspects of our lives, the internet has enabled us to rapidly access information. In particular, smartphones allow us to search and retrieve almost any information that we need “on the fly.” We book our flights and hotels, make restaurant reservations and communicate with our families on our phones. Who uses, or even possesses, a telephone directory anymore? However, a zombie-like relic of the telephone directory still lives on in clinical trials. It’s called the protocol, which: Is almost always a weighty document of perhaps 150 densely printed pages. Must only be used in its currently approved version, so it may need to be changed half a dozen times during the life of a trial. Each amendment must be approved for every individual site. Usually lives on a shelf in an office, often remote from where it is most needed in the clinical area in which its trial is being conducted. Is slow to search for information, especially if not immediately to hand. If it does have an electronic existence, it is usually as a PDF document which is hard to search in a hurry. The protocol hasn’t changed in any significant way for 40 years. It is no surprise that about 35% of adverse findings of FDA inspections are related to non-compliance with the protocol. This is not a harmless zombie! There are many examples to illustrate why printed protocols have outlived their utility. For example, typical oncology sites outside of the major centers may run about a dozen different trials at one time. It is a big ask to expect an investigator to remember the detailed inclusion and exclusion criteria for each one when they sit in-clinic seeing their patients. Their time constraints mean that they have only a few minutes to consider whether any patient in particular might qualify for one of these trials. They are unlikely to rummage through a dozen protocols to check. They may refer to a “cheat sheet” with the criteria listed. Are they sure it’s from the current protocol version? It’s easier to procrastinate and move along to the next patient waiting in line outside their office. Another possible trial participant misses out. Another example illustrates how adverse effects don’t respect office hours. Consider the following scenario. Its 8 p.m. on a Friday. A study coordinator in an Immuno-oncology study is about to sit down to dinner in a restaurant. A study participant phones urgently to report sudden onset bloody diarrhea and is desperate to know what to do. The protocol copy is two miles away. How will the coordinator instruct the participant exactly according to protocol? Do we expect them to recall precisely what the protocol says, or will they set off to consult it? Or will they just try to remember and hope that they are correct? It is vital that the right advice is given if the safety of the participant and the integrity of the trial are to be preserved. To effectively deal with the many weaknesses of relying on printed protocols that live on office shelves, we need to bring the whole process into the 21st century. Just as we have with almost all ways that we seek and find information in every other aspect of our lives. Do you have any other examples of how today’s paper protocol hinders clinical trial success? I’d like to hear them – you can email me at connectwithbrendan@teckro.com.
Blog
Nov 14, 2019
#WorldDiabetesDay: How Clinical Research Is Revolutionizing Diabetes Treatment
Someone dies from diabetes every 8 seconds. The number of adults with diabetes has doubled in the past three decades, according to the World Health Organization. On World Diabetes Day, we'd like to highlight the importance of clinical trials for diabetic patients. Clinical research has revolutionized the treatment of diabetes. Prior to 1921 diabetes was akin to a death sentence, until Banting and Best isolated insulin for injection. Originally extracted from cows and pigs, clinical researchers went on to develop synthetic insulin by modifying bacteria to mass-produce insulin in the lab during the 1980s. Clinical trials conducted during the 1950s gave us oral hypoglycemic agents for the treatment of type 2 diabetes. In recent years, there have been a number of exciting new developments in diabetes research: Glucose Monitoring Tattoos: Scientists at Harvard and MIT are currently exploring the possibility of using tattoos to detect changes in blood sugar, reducing the need for finger-prick tests. Traditional ink would be replaced by fluorescent biosensors that change color in response to high or low blood sugar. Insulin Patches: Recently, insulin patches for the treatment of diabetes have emerged from clinical trials. Insulin is delivered via a patch applied to the skin (like nicotine or contraceptive patches), removing the need to directly inject insulin. A recent study found that the patch is just as effective as insulin pens while providing a preferable delivery alternative for patients and clinicians. Light-Activated Insulin Producing Cells: Researchers at Tufts University have recently transplanted engineered beta cells (insulin-producing cells of the pancreas) into diabetic mice. When exposed to light, these cells produced 2x to 3x the normal amount of insulin, allowing glucose levels to be controlled without the need for drug intervention. New Drug Targets: Most recent of these innovations is the identification of the biological mechanism through which a rare mutation in the SLC30A8 gene can protect against the development of type 2 diabetes. This gene is involved in zinc transport in the body, which is important for insulin secretion. Now that we know how the mutation acts, this research potentially gives us a new target for future anti-diabetic and preventative therapies. As the exact cause of type 1 diabetes remains unknown, clinical research is vital. It will allow researchers to compare and contrast patient blood glucose levels, track metabolism, monitor organ functionality in relation to medications, shape the improvement of current treatments, bring new treatments to fruition, and perhaps one day, develop a cure. Have thoughts about how clinical trials can help with the treatment of diabetes? Please email connectwithaoife@teckro.com, I'd love to hear from you!
Blog
Nov 08, 2019
#STEMDay “Never Stop Being Curious”
The lack of women today in STEM (science, technology, engineering and mathematics) jobs is a problem. We believe with more role models and positive examples of women succeeding in technical roles, we can change this. To honor STEM Day, we spoke with Teckro Director of Clinical Operations Cayce Drobek about why she pursued a STEM career and her advice to encourage more girls into fields of science and technology. By way of background, Cayce studied at Middle Tennessee State University, graduating with a bachelor’s degree in mental health and biology. She went on to complete two master’s degrees, one in microbiology and a second in clinical research. Cayce has more than 12 years of professional experience in clinical research, working on numerous Phase I-IV trials. In addition, Cayce also worked with multiple contract research organizations (CROs) and investigative clinical trial sites, and she is a Certified Clinical Research Associate. Now, Cayce is applying her domain expertise at Teckro, where among other roles she has managed teams responsible for the quality and accuracy of the clinical research content in the product. Cayce, what first prompted you to go into a technical role? I have always been drawn towards science, math and technology. I have always been a very curious individual with a strong desire to constantly increase my knowledge. Even as a young child, I loved playing with my microscope and was always conducting experiments in the hope of making exciting new discoveries. I still love conducting experiments, trying new things, and making discoveries to solve everyday challenges in my personal and professional life. Because of my passion for science, I studied biology as an undergraduate, and then microbiology in graduate school.  While in school, I worked as a study coordinator for obstetrics and neonatology trials.  In this role, I experienced many of the common clinical trial challenges that site staff face every day. I ultimately developed and rolled out new processes at the research center with the help of technology to reduce some of the burdens on the staff. I’ve worked with multiple technology systems in my years in clinical research roles. While many of these technologies were aimed at reducing my day to day work-related burdens, there was still a need for simplification. This is Teckro’s mission, and I wanted to be a part of a solution that could really simplify how trials are conducted. Did you have any special encouragement, or role models when you started out? My mother is the primary reason for me pursuing a career in clinical research.  While I was in graduate school, she unfortunately was diagnosed with cancer. Caring for a loved one with cancer was extremely difficult. Thankfully, after participating in a clinical trial at Vanderbilt University Medical Center, my mother had complete remission. I was so grateful that she had this opportunity and I’m now extremely motivated and passionate about being a patient advocate. I work to make these types of clinical trial opportunities available not only for those who have cancer but for all types of diseases and disorders. What does a career in a STEM field mean to you? Science is not just a job; it is a passion. If your career is something you enjoy doing, you will lead a happier and more productive life. Working in a STEM field provides me with the thrill of new, exciting discoveries. It allows me to travel the world solving global challenges. It gives me broad, marketable skills. And I believe it increases my career opportunities, not just in biology or clinical trial-specific roles but in also roles for technology companies who need clinical trials subject matter experts. I’ve become a better problem solver and gained a better understanding of how things work. And not least of all, it’s fun! What advice would you give to young women considering a STEM career? Never stop being curious! For young women interested in pursuing a professional degree and career in a STEM field, I would recommend starting off by doing some independent research into what education and opportunities are available. You can also join organizations that advocate for girls and women in STEM, such as those listed on Girls Who STEM. One of my favorite quotes is from Mae Jemison, the first female African American astronaut to travel into space: "Don't let anyone rob you of your imagination, your creativity, or your curiosity. It's your place in the world; it's your life. Go on and do all you can with it, and make it the life you want to live.” We are naturally born with a desire to understand how and why things happen the way they do. This desire drives us towards science, which provides us the path to illumination of the many mysteries of the universe.
Blog
Oct 30, 2019
How to Effectively Engage Your Site Staff
At any clinical trial site, time is the most valued commodity for busy and over-burdened site staff. Communicating in a fast, effective way is key to sustaining a positive relationship with the team who is crucial in the successful delivery of your clinical trial. All of this is easier said than done, this is where site staff engagement becomes critical. What is site engagement? A good place to start is with the word engagement. This, by definition, is the creation of meaningful connections and interactions with people. Engagement is ensuring successful communication with trial sites and optimizing every interaction with your busy teams. Successful engagement should focus your awareness on an individual's behaviors and actions, based on who they are and what they do, allowing you to support them towards their goal. Who do I engage? Engage every individual. The clinical trial site team is composed of many different stakeholders or personnel. Each member of that team has their own way of communicating, their favorites and preferences. Engaging successfully does not just mean connecting with people. It requires the personalization of the message and identification of the audience to ensure that every interaction is rewarding. How do I engage? It is essential that you are aware of the needs and challenges of your staff, and that this forms the basis for your engagement and communication. While the Principal Investigator in a large research center may be interested in updates on the therapy area, other site staff in a smaller center may want succinct information to allow them to stay abreast of applicable study changes. Engage sites based on what they do. Technology now allows us to trigger communication and establish interaction based on a person's actions. Your site staff’s usage and access to study tools can dictate your engagement strategy. The timing of your communication will also be important. Take into account different time zones. For example, while a message may be received well on the East Coast of the US at midday on a Wednesday, that same message would reach a European-based site after they’ve left for the day. Deliver success for your sites Knowledge management can bring sites success. In turn, success will bring motivation and drive the overall trial experience. Knowledge delivered at the right time in the engagement process is critical to a successful interaction. We are all good at creating a contact list or sending an email to the study group email, but this is not engagement. Engagement evolves from meaningful, personal communications with your team. While it's true that creating and sustaining a successful engagement strategy with your site staff is a lot harder than simply passing on information, it's key to building effective relationships that are crucial to your clinical trial success. What strategies have you seen for effective site staff engagement? Please email connectwithbrian@teckro.com, I'd love to hear your thoughts.
Blog
Oct 08, 2019
On a Mission to Modernize and Simplify Clinical Research 
In the world of design, simplicity is achieved by removing, rather than adding more. The most elegant designs are those where there is nothing left to take away. Yet, a simple design is anything but simple to achieve as it requires a deep understanding of the purpose for the design.  At Teckro, we are applying the same concept of design simplicity to address today’s broken clinical trial process. You don’t have to look hard to find staggering evidence of how the industry is in desperate need of simplification. While there is nearly a three-fold increase in the number of trials just in the last 10 years, the practices to run a clinical trial haven’t changed in decades.  And while there are more trials, success rates aren’t necessarily improving. It is estimated that less than half of Phase II trials have successful outcomes. Of course, there are safety and scientific reasons that studies fail, which is the nature of clinical research. Our concerns are the avoidable blocking factors that stand in the way of success, such as too much paper, inconsistent communication, or a general lack of visibility into what’s going on with the study.  In today’s digital world, it is hard to believe that the primary interface for most clinical trials is a paper document or a PDF file that resides somewhere on a portal. Not only are these solutions impractical, they increase, rather than decrease, the interaction cost for busy site staff to fully engage with the trial. Unfortunately, the statistics reflect this with 40% of sites under recruiting and 80% of clinical trials failing to meet recruitment timelines.  Physicians have only minutes with each patient, and even less time to consider eligibility for a clinical trial. Yet, the protocol is rarely available where the patient is. These challenges of time and access extend beyond patient recruitment to all aspects of clinical trial compliance, including patient safety and toxicity management. The need for instant, reliable answers is paramount. At Teckro, we asked ourselves what can we take away to simplify clinical research? We’ve identified three key areas where we can modernize and simplify how things are done today so we can help protect patient safety and improve study quality:  Make all current, approved study information securely accessible in seconds anytime, anywhere through a smartphone or web-enabled device.  Create a secure, real-time digital connection to every stakeholder so that critical information and communication can be targeted to the right people at the right time.  Provide actionable insights into study performance so that issues can be detected sooner and proactively addressed.  By tackling these three areas, Teckro is bridging the gap between site staff and sponsors with a single platform. The focus is simplification. To design the most useful solutions possible, we spend countless hours of research and interviews to really understand the jobs that our users need to do.  Out of this deep understanding, we have solutions that make the process more transparent. Depending on the user, the questions are different. Site staff need quick answers to whether patients are eligible for a study, how to conduct a procedure, or how to manage an adverse event. Sponsors want to understand site engagement and whether there are early indications of any issues with the protocol or patient safety. All study stakeholders can use Teckro to find an answer to their study questions. Our corporate video provides a good explanation. By tackling complexity in clinical research, more sites will be engaged, their participation will be more successful, and they will extend access to more patients around the world. What do you think about our approach to simplicity? I would love to hear your thoughts. Please email me at connectwithgary@teckro.com.