
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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Jul 25, 2023 PRO Consortium and eCOA Consortium Announce Publication of an Open Access Article
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Jul 18, 2023 C-Path Integrates European Offices to Optimize Global Operations and Collaborative Partnerships
Publications
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Jul 25, 2023 Best Practice Recommendations for Electronic Patient-Reported Outcome (ePRO) Dataset Structure and Standardization to Support Drug Development
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Dec 16, 2022 Quantitative Study Findings: Comparability of a Provisioned Device Versus Bring Your Own Device…
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Dec 16, 2022 Qualitative Interview Findings: Comparability of a Provisioned Device Versus Bring Your Own Device…
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Jul 19, 2022 Comparing patient global impression of severity and patient global impression of change to evaluate test–retest reliability of depression, non-small cell lung cancer, and asthma measures
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Jun 8, 2022 Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ): measurement properties and estimated clinically meaningful thresholds from a phase 3 study
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