Monica Chmielewski and Alexandra Maulden Author Overview of FDA Diversity-Related Documents for Clinical Trials

Foley & Lardner LLP partner Monica Chmielewski and associate Alexandra Maulden highlight the key takeaways of several U.S. Food and Drug Administration (FDA) diversity-related guidance documents from 2016 onwards in their Applied Clinical Trials article, “An Overview of FDA Diversity-Related Documents for Clinical Trials.”

In the article, the authors explore the FDA’s efforts to promote diversity in clinical trials through various guidance documents. They assess the importance of inclusive recruitment practices and the avoidance of unnecessary exclusion criteria. Additionally, the authors examine the potential of decentralized trial models, telemedicine, and remote technologies to enhance participant diversity and emphasize the need for sponsors to stay updated with future FDA guidance to ensure broader representation in clinical trials.

“Sponsors should be aware that the FDA’s focus on expanding diversity in clinical trials will not disappear any time soon,” the authors conclude. “Instead, we expect the FDA’s focus on the issue to only intensify.”