Home » Guidance: Sponsors Should Define Role PRO Endpoint Plays in Clinical Trial
Guidance: Sponsors Should Define Role PRO Endpoint Plays in Clinical Trial
After three years of comment review, the FDA has issued a final guidance on patient-reported
outcome (PRO) instruments submitted in applications. Sponsors should define the role a PRO endpoint plays in trials so appropriate statistical methods
can be planned and applied, the guidance says. The guidance revises a February 2006 draft, for which the agency received 22 comments.
Clinical Trials Advisor
Clinical Trials Advisor
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