Data-driven Enhancement of Diversity in Clinical Trials: Making Clinical Trials Equitable to ALL

FDA Office of Minority Health and Health Equity (OMHHE) has continued its unwavering commitment and effort to support diverse participation in clinical trials through communications, policies, and advancing scientific research initiatives. In 2021, OMHHE established the Enhance Equity Initiative and created the office's first annual Health Equity Innovation Award funding opportunity to support research projects and communication resources to enhance 1) EQUITY in clinical trials by supporting efforts to advance diversity in clinical trials, 2) EQUITABLE data efforts by increasing research studies about diverse groups including, but not limited to, ethnicity, race, age, disability and geography, and 3) EQUITY of voices by amplifying FDA's communication with diverse groups and to ensure stakeholders, including consumers, are informed about FDA's efforts and to understand diverse patient perspectives, preferences and unmet needs. Additionally, OMHHE long-standing Diversity in Clinical Trials Initiative includes an ongoing multi-media, public education, and outreach campaign to help address some of the barriers preventing diverse groups from participating in clinical trials, 

Clinical trials have historically struggled to enroll representative patient populations, however, improvements have been made on multiple fronts. For instance, in 2016, women surpassed men in their participation in clinical trials (although the overwhelming majority of those were white women). Challenges still remain: racial and ethnic minority population groups, as well as older Americans, still have lower participation rates than would be representative. This presentation will present recent evidence collected as part of a report commissioned by the National Academies of Sciences, Engineering, and Medicine, demonstrate the economic potential of increasing clinical trial diversity in the United States, and indicate the opportunities for improving diversity through data-driven initiatives, including better information sharing, transparency and accountability.  

We need clinical trials with a patient population that mirrors real world use to accurately represent the safety and efficacy of drugs but unfortunately most trials fail to achieve this goal. This presentation will start with a brief overview of the current trends in drugs approvals and the regulatory guidance on diversity in clinical trials. Different strategies and efforts by the industry to improve diversity and the tools for alternative clinical trial designs will then be presented. The use of real-world data in clinical trials and decentralized clinical trials where patient burden for participation is reduced will be also be explored.