Payers, Medical Journals Could Help Push For Clinical Trial Diversity, Cavazzoni Says
The director of the US FDA’s Center for Drug Evaluation and Research acknowledged that the FDA cannot improve trial diversity alone.
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The usually lower-profile user fee reauthorizations could gain more attention for broader US FDA issues, said Andi Lipstein Fristedt, FDA deputy commissioner for policy, legislation and international affairs.
US FDA commissioner tells J.P. Morgan conference that the agency, industry, and the entire healthcare system need to change ‘at the same time’ in order for clinical trials to improve.
Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.