Defining Study Endpoints in 2012: The Journey Continues
Track
:
Track 07: Processes and Technologies for Clinical Research
Program Code:
206
Date:
Tuesday, June 26, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
John Weiler, CompleWare Corporation, United States
John M. Weiler, M.D., M.B.A. is President of CompleWare Corporation, a technology provider and CRO. Dr. Weiler was one of the three founding members of the eClinical SIAC and is chair of the new SE SIAC.
The SEALD Staff leads review and policy development related to the use of clinical outcome assessments in clinical trials to support medical product development and labeling or promotion claims of treatment benefit.
John Powers, SAIC/National Institutes of Health, United States
Dr. Powers is a physician/investigator and an internist and specialist in infectious diseases. Dr Powers has particular expertise in the design, conduct and analysis of clinical trials and has published numerous articles and book chapters in this area.
Description
This session will bring together life sciences professionals including regulatory authorities to discuss the taxonomy used for study endpoints and the importance of identifying what is meaningful to be measured before focusing on how to measure it.
Learning Objectives: Differentiate a patient reported outcome from an observer reported outcome Define a sign as contrasted with a symptom in the context study endpoints Discuss reasons why the concept behind a study endpoint should be defined prior to selecting the study endpoint itself.