Recent research underscores what many in the medical and regulatory community have long known: the lack of patient diversity in clinical trials is a significant problem. The limited representativeness of most clinical trials stands in the way of ensuring equitable healthcare access and outcomes, is estimated to cost billions of dollars a year in premature deaths and poor health, and further compounds health disparities already experienced by underrepresented and excluded populations.¹ As stated by the FDA, “The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health.”² So, what does representation look like? How can real-world evidence be a part of regulatory submissions for underrepresented patient populations? In this panel discussion with Cardinal Health Real-World Evidence and Insights and industry experts, we will examine representation vs representativeness and discuss ways in which real-world evidence can help overcome this public health challenge.

Learning objectives:

• Review the current state of lack of diversity in clinical trials
• Discuss representation vs representativeness
• Explore ways in which real-world evidence can mitigate these challenges and be used successfully in regulatory submissions

1. National Academies of Sciences, Engineering and Medicine
2. https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials

Sponsor: Cardinal Health