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U.S. Department of Health and Human Services

Drugs

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Review and Qualification of Clinical Outcome Assessments; Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for use in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. This public workshop is intended to provide information for and gain perspectives from patient advocates, health care providers, researchers, regulators, individuals from academia, industry, and other interested persons on various aspects of the development and implementation of COAs in the evaluation of treatment benefit.

Date:         October 19, 2011

Time:         8:30 a.m. to 5:00 p.m.

Location:   FDA White Oak Campus
                  10903 New Hampshire Avenue
                  Bldg. 31 Conference Center
                  Silver Spring, MD 20993

Webcast of Meeting

The webcast can be accessed via the following web links:

 

Presentations