Just the Beginning of Improving Diversity Initiatives in Clinical Trials

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: What was both of your initial reactions to FDA releasing the Diversity Action Plan guidance over the summer?

Park: Yeah, it's been really great to see the FDA, and specifically the Oncology Center for Excellence group taking the leadership on this much-needed initiative. I believe we certainly have a long ways to go, but I'm very optimistic that we'll continue to see improvements and making future studies be more representative, I'm grateful to be part of this dialog and contribute. In addition to our article that's been published in JAMA, we have submitted our recommendations to the FDA docket for this draft guidance as well.

Metcalfe: And just to add to what Jay said, I'm really appreciative that the FDA is using this iterative approach to develop the guidance. This is just the most recent draft with some substantial changes, but throughout this process, they've been integrating feedback from industry, community, patient organizations and academics, and we can really see the layers of feedback in building this latest draft guidance. I also agree with Jay that these changes are very much needed. We know that clinical trials have historically not represented the broader population, and in particular, have excluded non-white racial and ethnic communities. Given that historical context, it's really important that the work starts with those communities. We hope, though, that it's just the start, and that these changes have downstream benefits for other historically excluded and marginalized groups in the context of clinical trials, such as patients with disabilities or multiple comorbidities and individuals with diverse sexual orientations and gender identities. I also just want to make a nod to the broader impact that this guidance can have, which is really that the FDA is leading the way on improving representation in clinical trials and as a company that's based outside of the US, but does a lot of work in the US, it's exciting to see how these changes will likely ripple out into other regulatory bodies and health technology assessment agencies. This isn't just a great thing for people in the US, it's a great thing for clinical trials around the world.