Clara MacKay
CEO, World Ovarian Cancer Coalition

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.  

When the World Ovarian Cancer Coalition launched The Every Woman Study™ in 2018 we closed a significant gap in the understanding of the experiences of women living with ovarian cancer.  With more than 1,500 women from 44 countries contributing to the research, the study remains the largest review of ovarian cancer from the point of view of those living with the disease. 

The study identified many issues including how the lack of awareness on both the part of women and clinicians can lead to unnecessary delays in diagnosis. It also showed that there are significant variations between countries on all fronts with regards to access to specialist treatment, including genetic testing and crucial clinical trials.  

Because of this, many women are missing out on treatments that have the potential to improve survival and quality of life. The study also found significant shortfalls between what women need and what they receive in terms of information, as well as emotional and practical support. 

Introducing the Global Ovarian Cancer Charter

The Global Ovarian Cancer Charter is an important next step for the Coalition.  With six key global goals, the charter is a rallying cry for anyone with an interest in improving survival and quality of life for every woman diagnosed with ovarian cancer.

Ovarian cancer must become a global priority. Ovarian cancer is set to increase by almost 50% by 2050, and it remains the most lethal of all women’s cancers. We need to recognize the need for urgent action at every level - in every resource setting.  

Women must have access to diagnosis without delay. Too many women are diagnosed with ovarian cancer when they are in an advanced stage of the disease and too unwell to access or tolerate treatment.  We need to ensure that women and clinicians are aware of symptoms and they move quickly with appropriate tests.  

Women must have access to the best possible care. For many women access to best possible care, including specialist surgeons and clinical trials is simply non-existent. Lack of financial means must not be a barrier to best possible care. 

Women and doctors must have access to genetic testing and counselling. Women and clinicians must be aware of the importance of family history to understand personal as well as family risk.  New treatment options mean that genetic testing is more important than ever to inform decisions about best treatment.

We must improve ovarian cancer data. Knowing more about the different types of ovarian cancer and improving the overall diversity of data pertaining to where people live, as well as ethnicity, will help ensure that more women have access to the most effective treatment for them. 

Women must be able to access good quality information and support. Many women do not get the information they need at the time of diagnosis and beyond, nor do they feel they receive sufficient emotional help. We need to do much better to ensure that no woman goes unsupported. 

We genuinely believe that by showcasing the enormous commitment within the global ovarian cancer community, at all levels, we will be more powerful together. 

Meeting charter goals requires both individuals and organizations to help drive forward meaningful conversations that lead to actions. We are fortunate to have several what we call “Charter Champions” – those organizations whose innovations will help lead the way for change. 

In this spirit of innovation, we are delighted to be working with Teckro as our newest industry partner.  Within our global goals, clinical trials play an important role in advancing new ovarian cancer treatments. Making clinical trials as available and accessible to as many women as possible is paramount.  Teckro’s own commitment to make clinical trials more simple, accessible and transparent aligns very well with our Coalition priorities. 

We are very excited to be collaborating with Teckro!

To encourage conversation that will help bring our charter to life, we are launching our Charter Summit Series. These virtual events will look at what we can do to  progress against the charter goals by bringing together key stakeholders, including women with ovarian cancer, patient advocacy groups, clinicians, researchers, policy makers, and industry. 

The first event, Making Ovarian Cancer a Global Priority, is next Thursday, October 22.  We will share our 2020 World Ovarian Cancer Coalition Atlas, which sets out updated global data on incidence, mortality, and survival. Our expert global panel will discuss challenges and ideas on how to tackle the inequalities that this atlas brings to light. 

There are a number of ways you can get involved. For example: 

Sign your name to the charter on our PowerWall.

Participate in any – or all – of the Summit Series events.

Raise awareness within your organizations for the need for ovarian clinical research.  

The Global Ovarian Cancer Charter belongs to all of us who wish to change the future of ovarian cancer for all women – no matter who they are or where they live.  

CEO of the World Ovarian Cancer Coalition, Clara MacKay has nearly 20 years of experience in cancer advocacy, including senior level positions in UK organizations covering ovarian, pancreatic, bowel, prostate and breast cancer. Clara was a founding member of the World Pancreatic Cancer Coalition and Chair of Cancer 52 – a network of nearly 100 cancer groups representing the interests of rare and less common cancers. In 2015 she was appointed to an Independent Cancer Taskforce established by NHS England to develop a five-year strategy for cancer services. After 25 years in the UK, Clara returned to her native Nova Scotia, Canada in 2016. Clara was recently appointed Chair of the national Canadian charity Craig’s Cause Pancreatic Cancer Society.

The World Ovarian Cancer Coalition is a global not-for-profit that works to ensure that every woman diagnosed with ovarian cancer has the best chance of survival and the best quality of life possible. The Coalition works with a network of more than 160 patient advocacy partner organizations across 47 countries.

World Ovarian Cancer Coalition CEO Clara MacKay writes about the new Global Ovarian Cancer Charter. Teckro is the Coalition’s newest industry partner.

World Ovarian Cancer Coalition Launches New Charter | Teckro

Rallying the Global Community to Tackle Inadequacies for Women with Ovarian Cancer 

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. 

FDA approves first treatment for COVID-19. Gilead's antiviral drug Veklury (remdesivir) has been approved for the treatment of COVID-19 requiring hospitalization, making it the first drug officially approved to treat COVID-19. 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.

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.

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. 

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. 

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.

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.

This Teckro news digest includes updates on COVID-19 clinical research and also impacts of the pandemic other ongoing clinical trials.

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.) 

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 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. 

Lottie_01.json

Virtual coach to help with decision making. Teckro gives investigators and research staff a self-service way to find answers, such as eligibility, treatment and adverse event handling. It also connects research staff and CRAs with study teams and medical experts who can help guide them with helpful tips to limit protocol violations and deviations. 
Additionally, research staff can receive critical updates through Teckro, which is more secure and compliant than ad hoc channels like email, fax, text and voicemails. Teckro becomes that single source for study answers and the latest information.  And with push notifications, users receive an alert that there is a new message.

Lottie 02.json

Say goodbye to old-fashioned cheat sheets 

There is a lot more that Teckro can do to give monitors and study teams incredible insights into what is happening with their trials. We’ll save that for another day. 

For now, I hope I have shown you how we can finally replace cheat sheets, quick reference guides, and lengthy FAQ logs with Teckro. All study questions can now be answered by a digital pocket protocol, making Teckro the ultimate version of a 21st Century quick reference tool.

See Teckro in action with this simple 3-minute product overview video.

Teckro is the ultimate 21st Century clinical trial quick reference tool. Research site staff always have the protocol with them on a smartphone.

The Ultimate Clinical Trial Quick Reference Tool | Teckro

Part 2: Clinical Quick Reference Guides – The Ultimate, On-Demand Quick Reference Tool

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.

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 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.

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. 

You can view our recent webinar to learn more on how Teckro can help improve oncology clinical trial operations here. 

Technology can help to get oncology trials back on track after the disruptions caused by the COVID-19 global pandemic.

Getting Oncology Clinical Trials Back on Track | Teckro

Getting Oncology Clinical Trials Back on Track after COVID-19

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. 

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.

You can watch Cassandra Smith’s segment of the webinar in this recording. 

Sponsors play an important role in addressing clinical trials diversity. Partnering with the right sites will expand the reach to more underserved populations.

Clinical Trials Diversity: How Sponsors Can Close the Gap | Teckro

Diversity in Clinical Trials: How Sponsors Can Help Close the Gap

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. 

Source: ClinicalTrials.gov as of August 20, 2020

Not only are there a lot more studies, clinical trial design is also a lot more complicated. “Master” protocols, including platform studies, umbrella trials and basket trials are becoming increasingly common and increasingly complex. 

On top of it, clinical trial protocols are trying to accomplish a lot more. Take for example that study endpoints have increased 86% over the past 10 years, based on research from the Tufts Center for the Study of Drug Development (CSDD). 

More clinical trials and more procedures per protocol mean increased workload for those carrying out clinical trials. Unfortunately, research staff are supported with antiquated methods in running these trials, which is quite contradictory to the efforts to gather more data and validate more endpoints. 

For example, one way study teams have tried to assist research staff with heavy workloads is with protocol quick reference guides, also known as trial "cheat sheets.” The rationale is that these tools help research staff to more quickly and easily find the information they need to perform a specific task without reading the full protocol each time or referring to their own memory of the protocol. These guides do not replace a full protocol or other study manuals, but they do provide a supplemental way to deliver information. 

Do quick reference guides really help research staff? 

To find out how research site staff interact with the clinical trial protocol quick reference aids, Teckro teamed up with the Tufts CSDD to capture feedback from 228 respondents. The results are published in Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices.

Source: Tufts CSDD - Teckro 2020 Study on Investigative Site Protocol Administration Referencing Practices

Here are some of the results related to quick reference tools: 

Nearly two-thirds (65%) of respondents “somewhat” or “very” often refer to quick reference guides as a source of study information. 

However, one-quarter of the respondents finds them either not very useful or not useful at all. 

The majority of respondents (79%) report that quick reference tools are primarily created by study teams. 

More than one-third (36%) of respondents report that it takes more than 5 minutes to find answers from these quick reference tools. 

Is the time and effort to create and distribute quick reference guides justified? 

I think we can say that these quick reference tools can be somewhat helpful. However, the responses indicate that they are incrementally beneficial to site staff, meaning there isn’t a dramatic time saving or effort reduction with these tools. So you might ask why are we calling them “quick” reference tools? 

There’s also the time and effort to create quick reference guides. Given that the majority are coming from study teams, it does show a bit of a disconnect in what the study team deems helpful versus what people in the field actually find helpful. I’m sure they are created with best intentions, but the practical reality is that this time and effort to create these tools isn’t substantially improving the situation for research staff. 

Let’s take the case of one study coordinator assigned to 20 trials who has one patient eligibility criteria cheat sheet per trial. And let’s say he or she references each sheet 25 times over the course of each study. If we are conservative and say it takes five minutes to find an answer, that’s 42 hours spent getting answers to questions just related to eligibility. That is more than a standard work week – a lot of time for someone with an already heavy workload. 

Some could argue that the schedule of activities (SoA) table within the protocol is somewhat of a cheat sheet for information regarding the required procedures or assessments for each study visit. It’s certainly easier to navigate than accessing the full protocol when someone would have to review the table of contents to find the page number for the study procedures section, scan for a specific visit number, and then read the content located within that section. This can be useful when the table is only a page or two in length; however, it’s not uncommon for SoA in complex protocols to span across 20 plus pages. All of a sudden, our “quick reference tool” takes the form of another stack of papers. 

Let’s not forget another complication: protocol amendments. For a given clinical trial, it is not uncommon for multiple amendments after the study initiation. In fact, nearly 77% of Phase II trials and 66% of Phase III trials require two or more protocol amendments over the course of the trial, according to Tufts CSDD data. 

There is a risk that quick reference guides are not being updated, resulting in study non-compliance which could impact patient safety and quality of the trial data. Also, when information is found in multiple locations (i.e., full protocol, cheat sheet with select protocol information, etc.), it increases the chances of discrepancies. 

Rethinking quick reference tools for the 21st Century

Rather than incrementally better, we believe research staff need something substantially simpler and easier. We’re talking about finding answers immediately – never mind measuring in minutes. And answers are only from the latest study information all in one place that is easily and quickly accessible in order to reduce risk and duplicate effort.

This is our vision at Teckro. And it’s happening now at research sites around the world. In Part 2, I’ll go through how Teckro is the ultimate version of a 21st century quick reference tool. 

For more information on the Tufts-Teckro research, download the official Tufts report and the Teckro companion analysis. 

Clinical quick reference guides are intended to help research staff find answers such as eligibility or visit schedules. But they have limitations.

Clinical Quick Reference Guides - When Quick Isn’t Fast Enough | Teckro

Part 1: Clinical Quick Reference Guides - When “Quick” Isn’t Fast Enough

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.

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.

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.

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.

Drug development expert Dr. Ellen Vigdorth shares her thoughts on technology for faster, safer, more efficient vaccine trials.

Dr. Ellen Vigdorth on Improving Vaccine Trials | Teckro

Technology Can Be a “Guardian Angel” on the Shoulder of Investigative Site Staff, a Perspective From Drug Development Expert Dr. Ellen Vigdorth

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 

From this author

Every clinical trial starts with a question