FDAnews
www.fdanews.com/articles/123141-guidance-sponsors-should-define-role-pro-endpoint-plays-in-clinical-trial

Guidance: Sponsors Should Define Role PRO Endpoint Plays in Clinical Trial

December 21, 2009
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. It revises a February 2006 draft, for which the agency received 22 comments.
Clinical Trials Advisor