Drugs

Clinical Study Diversity Workshop Comments

The Biotechnology Innovation Organization (BIO) says it is committed to enhancing clinical trial diversity as part of its BIOEquality Agenda. In a response to an FDA 11/29-11/30/2023workshop on clinical trial diversity, BIO notes that under the FDA Omnibus Reform Act of 2022, the agency was required to issue draft guidance on the format and content of diversity action plans no later than 12 months after enactment of the law. “BIO urges the agency to issue this draft guidance,” the letter says. “We look forward to the opportunity to review and provide comments to FDA when the agency issues the draft guidance.”

In its comment, Pharmaceutical Research and Manufacturers of America (PhRMA) says it and its member companies “are committed to increasing participation of historically underrepresented populations in clinical research.” To that end, it says, PhRMA members voluntarily adopted the first industry-wide principles on clinical trial diversity in 11/2020. PhRMA says FDA guidances are an important resource for sponsors when planning their medical development programs. “We look forward to continuing to work with the agency and stakeholders to develop strategies for enhancing diverse participation in clinical trials, specifically the enrollment of historically underrepresented populations, and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups where scientifically appropriate,” the letter says. PhRMA also includes specific comments.

AdvaMed commends FDA for the “very successful public workshop…. We were pleased to see that speakers included representatives from the medical device industry that were able to share strategies for improving diversity in medical device trials, as well as articulate key differences between medical device and drug clinical trials.”

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