A Strategic Look at FDA’s Diversity Action Plan Guidance

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: Could you tell our audience a bit about your article “Diversity Action Plans in Clinical Trials” and provide an overview of some of the key themes?

Metcalfe: I think there are a few key themes in our piece. I'm going to touch on the one that I think is the most salient, which is this broader question of how we measure improvement and ensure accountability, and that really includes what we measure and also when we measure it. Right now, the FDA guidance is suggesting that we should use enrollment targets tied to epidemiological evidence about who is impacted by a given condition. While that's important, we don't really believe that enrollment targets alone are sufficient to measure change, because underrepresentation of specific groups in clinical trials is not something that just happened. It's really the result of complex societal processes and systems, and what that means is that in order to make meaningful change, we need to address those systems, both broadly at a societal level and then also at the trial level by making sure that trial processes are inclusive and reflect the needs and priorities of patients and communities that have been historically excluded. The focus of our piece is really about shifting how we think about measuring change in representation in clinical trials and then grounding that shift in meaningful patient engagement.

Park: Building on what Rebecca has said, our article is really about adding to this important initiative that's being honed by the FDA, and it's been really nice to see such an important collaboration between the FDA, industry, and other patient organizations on these diversity action plans. While we believe that this the right step forward, we can learn from other diversity initiatives outside of the clinical trials landscape. We have seen in other areas where diversity quotas have been implemented, positive changes were only achieved when there were also accountability implemented as well. Our paper intends to provide actionable recommendations with the framework for risk-based monitoring that is commonly used in clinical trials. Already central to our recommendation is what we call patient-reported process metrics. The rationale these process metrics in how patients are engaged for enrollment and how they're retained during the follow up is similar to PROs or patient-reported outcomes as a supplement to the enrollment targets we can benefit from hearing and learning from the subjective experiences that patients are involved in during their clinical trial experience, and by listening to the patients and giving them a voice, we can be more patient-centric instead of just having enrollment targets. There will be some other benefits as well. In terms of managing risk, we can assess these process metrics during the trial at the same time, we're monitoring these enrollment targets. This couldn't be an important way to modify enrollment strategy. In the unfortunate case that the trial itself is running behind, it's in diversity enrollment targets, and after the trial, we can also use these process data generated to plan for post marketing, market surveillance studies, should they become necessary, or other future studies that diversity action plans will be mandated for.