FDA Urges Drug Sponsors To Expand Trial Eligibility, Cut Patient Burden

By Beth Wang / June 10, 2019 at 5:35 PM
FDA hopes to encourage more diversity in clinical trials through draft guidance that lays out how drug and biologic sponsors can broaden eligibility criteria, avoid unnecessary exclusions and reduce burdens on trial participants. Broadening the criteria will also help sponsors to get a better handle on who will use the product if it is approved, the agency says in the draft guide published Thursday (June 6). People often are excluded from clinical trials without strong clinical or scientific justification, FDA...

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