Original Date: Tuesday, April 13, 2010
Presented by: Jean Paty, PhD, Founder and Senior Vice President, Scientific, Quality and Regulatory Affairs, invivodata, inc.
This webinar is the third part of invivodata's 2010 PROficiency webinar series which focuses on the FDA's final PRO Guidance. In this session, Dr. Jean Paty will review specific considerations that biopharma researchers need to keep in mind when implementing PROs in clinical trials. The webinar will focus on specific elements of PRO trial design, including blinding and randomization, missing data, and clinical interpretation of the PRO data. This will be followed by a detailed discussion on methods of PRO administration in the context of trial execution.