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Session 1: Perspectives on Study Endpoints: Where Are We Now and Where Are We Going?
Session Chair(s)
J. Jason Lundy, PHD
Principal
Outcometrix, United States
Study endpoints play a central role in the evaluation of the safety and efficacy of new drugs. For regulatory approval, the selection of an endpoint should represent a clinically meaningful benefit as a direct measure of how a patient feels, functions, and survives. In addition, the selection and evaluation endpoints is also important for health care reimbursement, as well as informing patients and clinicians about the benefits and risks of therapeutic interventions. These keynote addresses will discuss the role and evolution of study endpoints in the current environment, and the future of study endpoints in a changing landscape of therapeutic advances and reimbursement schemes.
Speaker(s)
Regulatory Perspective
Janet Woodcock, MD
United States
Retired, Principal Deputy Commissioner, FDA
Payer Perspective
Mark B. McClellan, MD, PHD
Duke-Margolis Center For Health Policy, United States
Director and Robert J. Margolis M.D. Professor of Business, Medicine and Policy
Q&A Panel Discussion
United States