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 April 29-30, 2015 the Sixth Annual Patient-Reported Outcome (PRO) Consortium Workshop will be held in Silver Spring, Maryland. The overall Workshop objectives are to:
- Discuss how all stakeholders can work together to improve patient-focused drug development
- Provide updates on the PRO instrument development and qualification activities within the PRO Consortium’s working groups
- Describe the qualitative and quantitative research that led to development of the Asthma Daily Symptom Diary (ADSD) within the Asthma Working Group
- Discuss the development and implementation of well-defined and reliable clinical outcome assessment (COA) tools for pediatric clinical trials
- Discuss ways to optimize qualitative and quantitative research to more efficiently generate evidence supporting the content validity of new PRO instruments
For more information about the Sixth Annual Patient-Reported Outcome (PRO) Consortium Workshop, click here.