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PRO-ving Ground: FDA Review Teams Commit to Patient-Reported Outcomes

 
• By Cole Werble and Kate Rawson

FDA recently announced a significant step in furthering the development of patient-reported outcomes: the planned creation of a web-based compendium of clinical outcomes assessments, including PROs. But an even more significant sign that FDA is committed to developing new patient-reported endpoints came directly from reviewers – including some divisions that have not historically been out front on the issue.

Review divisions within the Food & Drug Administration are signaling a commitment to the development and use of patient-reported outcomes during the clinical development of new drugs and biologics – both in public statements from agency officials and in regulatory policy changes that would help develop new PRO tools and encourage drug sponsors to meet directly with FDA review teams to discuss new endpoints.

While that commitment has been slowly building within the agency over the past few years, a number of review managers from the Center for Drug Evaluation & Research used an...

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