Reflections on DIA’s Annual Global Meeting, Part 2

By Aman Khera, Global Head of Regulatory Strategy,

8 Practical Actions to Increase Diversity in Clinical Research

For months now, clinical researchers across the world have held meaningful conversations about increasing diversity in clinical trials. COVID-19 has illuminated how essential it is for clinical research to serve all people equitably—from all walks of life, across all parts of the globe. Now, many industry leaders are ready to move on from talking about inclusion to doing something about it.

At this year’s DIA Global Annual Meeting, I was both humbled and honored to chair a session with fellow experts designed to share practical strategies for taking action to bolster diversity in the clinical research space. My colleagues on the panel included: Adam Brown, founder and CEO of ClinArk; Rebecca Griffith-Eskew, VP of Clinical Operations at Salarius Pharmaceuticals; and Kirk Taylor, SVP of North American Medical Affairs at EMD Serono. Together, we provided perspectives from a mid-sized CRO, a niche clinical feasibility provider, a virtual biotech, and a multinational large pharmaceutical company.

Part 1 of this blog series explored some of the inclusivity challenges discussed by the panel. This article will offer some of the group’s practical actions to enhance diversity, such as starting at the grassroots level.

The panel noted that companies can play a key role in educating the public about clinical research if they engage with their communities. Activities don’t necessarily have to be related to clinical trials; a company could sponsor a community garden, for example. The idea is just to make people from a wide variety of backgrounds comfortable hearing and talking about clinical research.

Other actions to increase clinical trial diversity suggested by the panel include:

  • Incorporate a diversity strategy into RFP responses. CROs should consider offering up solutions for how they expect to increase diversity in a particular study—even if the potential sponsor doesn’t ask for them.
  • Begin removing barriers to participation early. When thinking about the Target Product Profile (TPP), keep diversity in mind and concentrate on removing barriers. During early phase trials, during the protocol writing phases, consider how burdensome the clinical trial design might be for diverse groups of patients.
  • Optimize protocols with patient input. For all indications and all phases of research, remember that the more complicated the protocol, the more we increase challenges with socioeconomic, demographic, and geographic access. Therefore, ask potential patients about the barriers they have—and ways to overcome those barriers—from the very beginning. People with the disease can provide a lot of valuable insight.
  • Engage patient advocacy groups early. Advocacy groups are great resources for bringing the patient voice into trials. However, they can’t just drop everything they’re doing on a dime. The earlier you can talk with them about collaboration, the better.
  • Take a disruptive approach to site selection. Leveraging the same data sets to find sites means you’re effectively fishing from the same pond and catching the same fish over and over. Bigger pharmaceutical companies may instead want to tap into a Medical Science Liaison (MSL) team to seek new sites. Niche feasibility service providers can build trust and collaboration on the ground, saving time for larger sponsor companies and also for virtual companies.
  • Deepen CRO/sponsor collaboration on “first patient in” (FPI) goals. Pressure to deliver a fast FPI timeline leads many CROs to go back to tried-and-true sites—which contributes to the diversity problem. Sponsors and CROs could perhaps negotiate to recruit a quick start-up site for FPI, but give further care and consideration to sites with deeper, more diverse potential patient populations. In conjunction, CROs should prioritize asking sites about their patient populations and how to accommodate them.
  • Don’t assume decentralized clinical trials (DCTs) automatically solve diversity challenges. DCTs have unquestionably enhanced the clinical research paradigm. However, the panel cautioned that wrongly assuming DCTs fix the diversity problem could actually amplify it. Some excellent, long-overdue tools are now helping bring trials to patients, but we must not forget that access still is not equal—whether it be access to a doctor, phone or the internet.

There are many different layers involved in increasing diversity in clinical trials, and there’s no set rule book. What works in one local community may not work in another. As industry members, we all have a responsibility to pull back the layers, find solutions, and provide access to clinical research to everyone. Ultimately, it’s all about people, relationships, and trust.

CATEGORIES 
Diversity & Inclusion