Analyzing The FDA's Approach To Diversity In Clinical Trials

By Hannah Kulkarni and Marc Wartenberger, CRIO

The FDA has proactively addressed the underrepresentation of certain demographics in clinical research by issuing guidance to enhance diversity in clinical trials, ensuring the safety and efficacy of medical products across varied populations. Initial efforts in 2016 focused on basic ethnicity and race metrics but proved inadequate in capturing comprehensive diversity. This led to the release of a more robust guidance document in November 2020 that focused on broadening eligibility criteria to accommodate diverse participants, improving study design to ensure inclusive practices, and engaging patient advocacy groups for rare diseases. These measures aim to enhance study quality by better reflecting real-world patient demographics.

The guidance was adapted again in April 2022 to further emphasize diversity by mandating sponsors to submit Diversity Plans (DPs) during critical phases, such as IND and IDE applications. These plans outline enrollment goals, assess differential safety and effectiveness, and include strategies to monitor disparities, extending to pediatric studies. Learn how utilizing diverse data resources and collaborating with stakeholders enables sponsors to foster a culture of inclusivity, meeting regulatory requirements and contributing to equitable healthcare, ultimately advancing medical science and improving patient outcomes.