US FDA Calls For Clinical Trial Diversity Plan ‘As Soon As Practicable’ In Product Development
Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is applicable from IND through approval.
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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.
Should Obese Patients Be Included In Every Drug Development Program?
FDA officials question whether modeling tools can predict which drugs have different disposition in obese populations. They say physiologically-based pharmacokinetic data cannot be used as a surrogate for actual clinical trial data at this time.
Clinical Trial Diversity Action Plans Required Under US Funding Bill
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.