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.
