Advancing Development and Use of Patient-Reported Outcomes in Drug Development: Near-Term Opportunities

Developing valid and reliable instruments for measuring patient-reported outcomes (PROs) is the most direct approach to gaining insights from patients about their symptoms, functional status, treatment preferences, and health-related quality of life. While there is growing interest among drug developers, clinicians, payers, regulators, and patients in the development and widespread use of PRO instruments, progress has been slow, owing to a range of structural, logistical, and communication barriers.

On October 6, 2014, the Engelberg Center for Health Care Reform at Brookings, in cooperation with FDA, convened an expert workshop, “Advancing Development and Use of Patient-Reported Outcomes in Drug Development: Near-Term Opportunities”. This workshop was the second in a series of meetings that will explore the major issues related to the development and use of PRO instruments to support labeling claims. Through these meetings, Brookings hopes to create a venue for stakeholders to identify and prioritize for action the most promising strategies to address the major barriers, and identify ways that FDA and other stakeholders can facilitate these efforts. This ongoing discussion will also help to inform a public workshop that FDA will hold in spring 2015, which will focus on the development, use, and qualification of drug development tools, among other topics.

Information on the first workshop, which took place on July 17, 2014, is available here.