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:
Marc K Walton, CDER, FDA(PDF - 400KB) [ARCHIVED] Thomas R. Fleming(PDF - 404KB) [ARCHIVED] Laurie Beth Burke, CDER, FDA(PDF - 373KB) [ARCHIVED] John H. Powers, NIH(PDF - 1.5MB) [ARCHIVED] Jeremy Hobart(PDF - 2.3MB) [ARCHIVED] Nathaniel Katz(PDF - 946KB) [ARCHIVED] Todd C. Edwards and Donald L. Patrick(PDF - 541KB) [ARCHIVED] Nancy Kline Leidy(PDF - 284KB) [ARCHIVED] Maria Isaac(PDF - 616KB) [ARCHIVED]