March 23, 2010

Sheraton Silver Spring Hotel
8777 Georgia Avenue – Silver Spring, MD 20910

SPONSORED BY:
Critical Path Institute
Food and Drug Administration (FDA)

The Patient-Reported Outcomes Consortium is a public-private partnership established by Critical Path Institute (C-Path) in cooperation with the U.S. Food and Drug Administration (FDA) and the medical products industry in 2008. The PRO Consortium brings together scientists from C-Path, industry, academia, and regulatory agencies in a pre-competitive environment for the purpose of developing, evaluating, and qualifying PRO instruments for use in clinical trials designed to evaluate the safety and efficacy of medical products.

On March 23, 2010 the FIRST ANNUAL PATIENT-REPORTED OUTCOME CONSORTIUM WORKSHOP was held in Silver Spring, Maryland. The overall Workshop objectives were to:

• Describe the genesis, purpose, and structure of the (1) Critical Path Institute and (2) PRO Consortium
• Explore the importance of PRO endpoints in the evaluation of medical products
• Discuss two FDA guidance documents relevant to PRO instrument development and use
• Describe the PRO Consortium’s role from various stakeholders’ perspectives
• review the progress made by the PRO Consortium’s six working groups
• provide an open forum for further discussion of the PRO Consortium’s function, processes, and deliverables

The following Workshop Agenda provides an overview of the day-and-a-half-long meeting as well as links to the slide sets and posters presented.

Workshop Agenda
March 23, 2010