FDA Guidance: Enhancing Diversity in Clinical Trials

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Over the past few decades, FDA policy initiatives have focused on promoting enrollment practices that led to clinical trials better reflecting the population most likely to use the drug is approved, primarily by broadening the eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be unnecessarily underrepresented in many clinical trials. This guidance recommends approaches that sponsors of clinical trials to support a new drug application or a biologics license application can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their clinical trials.

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Over the past few decades, FDA policy initiatives have focused on promoting enrollment practices that led to clinical trials better reflecting the population most likely to use the drug is approved, primarily by broadening the eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be unnecessarily underrepresented in many clinical trials. This guidance recommends approaches that sponsors of clinical trials to support a new drug application or a biologics license application can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations in their clinical trials.

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