TL12: Investigator Assesement vs. Blinded Adjudecation of Clinical Endpoints
*Andrei Breazna, Pfizer inc 

Keywords: Endpoint Committee, Adjudecation, Discordance

Blinded adjudication of clinical endpoints is used in several clinical areas like: oncology, cardiovascular, hematology, etc. Quite often, there are differences between the investigator’s assessment and the Endpoint Committee’s findings. In those situations, the investigator may modify the treatment (responding to a perceived treatment failure or safety issue), even if the Endpoint Committee thinks otherwise. This creates situations where the efficacy and safety profiles may be affected by some less-than-objective decisions. What is your experience with adjudication discrepancies? What are statistical or logistical ways of addressing this?