FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Announces Meeting to Discuss Eligibility Criteria in Clinical Trials

Feb. 2, 2018

The FDA scheduled an April 16 public meeting on evaluating inclusion and exclusion criteria in clinical trials.

The meeting will review matters related to eligibility criteria and their impact on patient access to investigational drugs, and ways to involve diverse patient populations in clinical trials. Topics will include risks and benefits of clinical trial participation, alternative clinical trial designs that may increase diversity, and how some patient populations can benefit from alternative design trials, among others.

The meeting will be held at the National Press Club in Washington D.C., from 8:30 a.m. to 5 p.m.

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