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Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval
Session Chair(s)
Yeh-Fong Chen, PhD
Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
United States
For slowly progressed diseases, it may take years, if not decades, to observe clinical outcomes, such as mortality. Owing to the regulatory agencies’ accelerated approval pathway, drug developers can now consider applying for a drug approval based on surrogate endpoints. In this session, many surrogate endpoints adopted in various diseases and statistical methods for determining the validity of the surrogacy will be discussed, including their implementation in real case examples.
Learning Objective : Describe cases that utilize the accelerated approval and what good surrogate endpoints are for common and rare diseases; Identify how to apply appropriate statistical methods for assessing the association between surrogate endpoints and clinical outcomes.
Speaker(s)
FDA Update
Aloka Chakravarty, PhD
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Director, Data Analytics
Statistical Assessment of Potential Surrogate Endpoints: Is the Bar too High?
Marc E. Buyse, DrSc
IDDI, United States
Chief Scientific Officer
Using the Biomarker Endpoint for Accelerated Approval
Stephanie O. Omokaro, MD
FDA, United States
Lead Medical Officer, Office of New Drugs, CDER
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