Monica Chmielewski Comments on FDA Efforts to Boost Diversity in Clinical Trial Enrollment

Foley & Lardner LLP partner Monica Chmielewski is quoted in the Law360 article, “FDA Seeks Input On Reporting Race, Ethnicity In Drug Trials,” offering insight on updated draft guidance from the U.S. Food and Drug Administration that outlines the agency’s expectations for collecting race and ethnicity data in drug and medical device research.

Chmielewski, who is vice-chair of Foley’s Health Care Practice, said the draft guidance is part of a broader federal effort to bolster diversity in clinical trial enrollment and ensure accurate data collection.

“Historically, the clinical trial population has been Caucasian males,” Chmielewski said. “The FDA rightly recognizes there are these other populations not taken into consideration, and they need to be accounted for.”

Chmielewski explained that the recommended data collection practices come as federal agencies and researchers push to build trust with underrepresented communities and encourage diverse participation in clinical trials. She noted the use of decentralized clinical trials that allow people to participate in studies from home or at a community center through telehealth technology as one new strategy in these efforts.

“There’s the ability to reach diverse populations and some of these underrepresented groups in ways you couldn’t before, through the use of technology,” Chmielewski added.

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