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Advancing the Science of Study Endpoints: Endpoint Evolution During Drug Development – Time to Deterioration Endpoint Case Study

21 September 2018

North Besada, MD

Drug Information Association

Invited speaker and panel discussant

Session abstract:

To sufficiently define a clinical trial endpoint, both a relevant clinical outcome and an appropriate statistical test are needed. In addition, the interpretation (or clinical meaningfulness) of that data also should be specified. This session will describe the distinction between outcomes and endpoints, and discuss the evolution of endpoints throughout the drug development lifecycle. Time to deterioration endpoints in oncology clinical trials will be used as a case-study to illustrate endpoint positioning and interpretation.

Title of my presentation: Endpoint Selection and Positioning