Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Urges More Diversity in Clinical Trials in Draft Guidance

Publish date:: July 25, 2019

Key clinical point: FDA issues draft guidance on achieving more diversity in clinical trials.

Major finding: The draft document builds on work in diversifying cancer trials and expands principles to all therapeutic areas.

Study details: Draft recommendations cover areas of expanding participation through broader population access, less burdensome participation, and other enrollment practices.

Disclosures: FDA makes no disclosures in issuing this draft guidance for comment.

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