The Role of Risk-Based Monitoring in Achieving Greater Diversity

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: How can risk-based monitoring be adapted to support diversity initiatives?

Park: Risk-based monitoring or RBM really helps to ensure that we can conduct quality trials by monitoring and mitigating risks as they occur. With RBM, we often think of it as a way to monitor safety and data quality, but now with this mandate, the sponsor of each trial now faces the risk of falling short of these enrollment targets, and they may be required to conduct post-marketing surveillance studies. In reaction to diversity action plans, many trials are already using RBM to monitor enrollment targets over time, but one question we can ask ourselves is, “What happens when the trial is falling short of these enrollment targets? How do we respond to that?” With these patient-reported process metrics, we can better assess what the patient experiences during the clinical trial, when they are being approached for their enrollment, and how they're being managed during the follow-up visits. In trial sites located in regions with diverse populations, we can perhaps ask why the minority populations are not being enrolled into the study and why they may not be adequately retained in the study as well.