What does diversity mean in practice for FDA?
In 2022 we saw some new text added to a FDA stock response template, which let each and every sponsor know that diversity plans would be needed as they proceeded through development—and even encouraged sponsors to look at patient focus drug development, and diversity early on in their clinical trials.
Now, as we move into 2024, FTA is firming up the diversity plan process. Moreover, there’s plans for FDA to look across diversity, plans for trends, and to better understand how we can bring diversity in the clinical trials in the future.
To me, this is particularly significant. Clinical trials tend to represent the majority populations, and historically women and minorities — groups, who may be more prone to hypersensitivity or adverse drug reactions— have not been adequately, represented in clinical trials.
For example, for the long marketed drug warfarin (apprived by FDA in 1954) Asians, Latinos, and African Americans have higher risks of warfarin-related potentially deadly intracranial hemorrhage than individuals with European ancestry. Yet, it took decades before this was known.
Understanding gender, ethnic, and other population differences in drug response is a critical next step in drug development and healthcare
#nursesonlinkedin #healthcare #drugdevelopment #biotech #dei #diversity #pharma #fda #regulatory
In April 2022, FDA issued a draft guidance recommending that sponsors of certain drugs, biological products, and devices, submit Diversity Plans that describe their plan to enroll racially and ethnically representative populations in clinical trials intended to support the approval or licensing of these medical products.
In the following report, the Oncology Center of Excellence Project Equity analyzes Diversity Plan submissions in the CDER oncology divisions during the first year following publication of the draft guidance.
https://lnkd.in/e-A8hRX9
Senior Vice President, Regulatory at C4 Therapeutics
1moSo proud to work with this incredible team for the benefit of incredible science and therapies for patients.