In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent article published in JAMA titled, “Diversity Action Plans in Clinical Trials.” In addition to key takeaways from the article, Park and Metcalfe discussed the FDA’s new guidance for diversity action plans in clinical trials, the role of risk-based monitoring as a tool for improving diversity, and the importance of patient-reported outcomes.
A transcript of Park and Metcalfe’s conversation with ACT can be found below.
ACT: While the FDA Diversity Action Plan guidance is a step forward, why do you feel that even with diversity quotas, trials may still have limited engagement with relevant underrepresented communities?
Metcalfe: That’s a great question. As Jay and I mentioned earlier, really a major theme in our piece has been the need for system change and accountability for that change, and specifically measuring how clinical trials are done, and not just who participates in them. The goal of these recent initiatives by the FDA is twofold. On the one hand, they support the generation of evidence that better reflects the population of patients that may be eligible for a given treatment, so that’s a scientific good. On the other hand, these initiatives support relationship and trust building with historically marginalized and excluded communities, many of which have been exploited by medical research in the past, and that’s a good for the fabric of our society. Focusing just on the numbers by using enrollment targets will address the first goal, but not really address the second goal, so in this article, we advocate for process measurements that are designed in collaboration with relevant underrepresented communities to make sure that what matters to community members about how research is done is identified, and then through monitoring, we can make sure researchers are accountable for supporting inclusive processes throughout trials. A key component of this at the system-level is making sure that underrepresented communities don’t just participate in clinical research, but they really lead clinical research. Studies suggest that when we have concordance between investigator and participant race and ethnicity, that improves the enrollment of ethnic and racial minorities. On the other hand, we also have studies showing that female and Black individuals are underrepresented among principal investigators, so among those folks that are leading research. In addition to improving the processes actually within a given trial, we also need to think more broadly about what perpetuates these systems that led to this exclusion in the first place, and then what changes are needed at that higher level to improve representation in clinical trials in a sustainable way.