From this author

Blog
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.
Blog
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
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.  
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.