Dr. Jean Paty

Presented By: John Powers, George Washington University & University of Maryland and Jean Paty, Founder and Chief Scientist and Regulatory Officer, invivodata

Original Air Date:  November 14, 2011

On October 19, FDA conducted a public workshop to discuss measurement principles for Clinical Outcome Assessments (COAs) used in clinical trials for new drugs. COAs include patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, and observer reported outcome (ObsRO) measures. The workshop outlined FDA’s expectations for the development and qualification  to establish that COAs are fit for purpose and appropriate for their context of use.

In this webinar, former FDA official Dr. John Powers and invivodata/PRO Consulting’s Dr. Jean Paty will review the key take-aways from the FDA workshop and discuss the implications to researchers using COAs in new medical product development.  Specific focus on choice and development of different types of outcomes will be reviewed, including the importance of content validity, reliability, construct validity and other measurement properties for all types of outcomes that are strategic to product development.