From this author

Blog
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.
Blog
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.
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
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
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
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
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.