August 28, 2012

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

SPONSORED BY:
Critical Path Institute

The Patient-Reported Outcome (PRO) Consortium is a public-private partnership established by the 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 as primary or secondary endpoint measures in clinical trials designed to evaluate treatment benefit.

On August 28, 2012, the PRO Consortium’s Rheumatoid Arthritis (RA) Working Group held a workshop in Silver Spring, Maryland titled Toward Consensus Development: Qualifying Endpoint Measures for Rheumatoid Arthritis Clinical Trials. The workshop’s objective was to identify RA-related symptoms and RA-defining decrements in physical function that could be explored as potential PRO endpoints in clinical trials to support label claims for RA drugs. Along with RA Working Group members and C-Path personnel, participants included RA patients, representatives from the US Food and Drug Administration, National Institute for Arthritis and Musculoskeletal and Skin Diseases, American College of Rheumatology, Outcome Measures in Rheumatology, and European League Against Rheumatism.

The expected outcome of the workshop was a research agenda aimed at collecting evidence for FDA qualification of one or more PRO instruments that capture concepts that are relevant to patients with RA. Once qualified, the PRO instruments will contribute to the assessment of treatment benefit in RA drug registration trials. The following agenda provides an overview of the day-long meeting as well as links to the slide sets presented and the workshop minutes.

Workshop Agenda
August 28, 2012