Should US FDA Refuse Approval If Women Under-Represented In Clinical Trials?
Idea suggested during 'Great Debate,' but agency official says no adlibbing is allowed in the regulations.
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Clinical Trial Diversity: FDA Rejects Calls For Enrollment Mandates
Requiring that underrepresented populations be enrolled based upon disease prevalence is only way to ensure adequate diversity, some stakeholders say; agency continues to prefer more flexible approach offered by guidance, and PhRMA says mandates would lengthen development timelines for new drugs.
Clinical Trial Subgroup Data: How Much Is Enough?
FDA could use epidemiology data on disease prevalence or insurance claims data to determine acceptable subgroup sizes, advocates say.
PhRMA’s “I’m In” Campaign Looks To Connect Minorities To Studies
Extension of the Clinical Trial Engagement Network is aimed at increased diversity in clinical trials, which is becoming increasingly important as more drugs are targeted at specific groups.