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Activity Number: 577 - Estimands: Some Perspectives from an FDA Working Group
Type: Topic Contributed
Date/Time: Thursday, August 6, 2020 : 3:00 PM to 4:50 PM
Sponsor: Biopharmaceutical Section
Abstract #309888
Title: Safety Estimands: A Regulatory Perspective
Author(s): Cesar Torres* and Gregory Levin and Mat Soukup and Sai Dharmarajan and Tae Hyun Jung and Maria Matilde S. Kam and Bo Li and Sirisha Mushti and Therri Usher and Jialu Zhang
Companies: FDA and FDA and FDA and FDA and FDA and OTS/CDER, FDA and FDA and FDA and FDA and FDA
Keywords: estimands; safety

While progress has been made in the development and implementation of estimands to evaluate key efficacy endpoints, there remains a relative lack of discussion of estimand considerations for the evaluation of key adverse events. One of the objectives of FDA CDER’s Office of Biostatistics Safety and Benefit-Risk working group has been to develop best practices for the Office’s evaluation of safety and benefit-risk, including the choice of safety estimands and appropriate methods to evaluate them. This talk will describe the working group’s current thinking regarding safety estimands, and will use an example indication to illustrate the thought process on different considerations when defining and evaluating safety estimands.

Authors who are presenting talks have a * after their name.

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