
Patient-Reported Outcome Consortium
The Patient-Reported Outcome Consortium supports patient-focused drug development by obtaining qualification of clinical outcome assessment tools that measure how patients feel and function in their everyday lives as a result of treatment.
News
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Jan 7, 2021 Diary for Irritable Bowel Syndrome Symptoms-Constipation is the First Patient-Reported Outcome Consortium Measure Used to Support an FDA-approved Label Claim
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Sep 21, 2020 C-Path Awarded FDA Drug Development Tool Research Grant to Develop a Qualification Plan for the Symptoms of Major Depressive Disorder Momentary Assessment (SMDDMA)
Past Events
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Feb 17, 2021 WEBINAR: eCOA: Getting Better Together Initiative – An Update from C-Path’s PRO Consortium and ePRO Consortium
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Apr 22, 2020 - Apr 23, 2020 11th Annual Patient-Reported Outcome Consortium Workshop – Cancelled
Publications
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Sep 13, 2019 Symptoms of Major Depressive Disorder Scale: Performance of a Novel Patient-Reported Symptom Measure
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Sep 6, 2018 Response scale selection in adult pain measures: results from a literature review
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Sep 6, 2018 Literature review to characterize the empirical basis for response scale selection in pediatric populations
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Sep 6, 2018 Literature review to assemble the evidence for response scales used in patient-reported outcome measures
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Jun 1, 2018 Informing the tolerability of cancer treatments using patient-reported outcome (PRO) measures: summary of an FDA and Critical Path Institute workshop
Relevant Links
PRO Consortium Measures and Licensing Information
BEST (Biomarkers, EndpointS, and other Tools) Resource
Division of Clinical Outcome Assessment (DCOA)
COA Qualification Program Website
Drug Development Tool (DDT) Qualification Website – FDA
Guidance for Industry: Multiple Endpoints in Clinical Trials (Draft)
Guidance for Industry: Qualification Process for Drug Development Tools
Guidance: Search all FDA official guidance documents and other regulatory guidance