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Wednesday, September 25
Wed, Sep 25, 2:45 PM - 4:00 PM
Estimands for Safety and Benefit-Risk Evaluation

Safety Estimands: A Regulatory Perspective (301001)

Sai Dharmarajan, FDA 
Tae Hyun Jung, FDA 
Matilde Maria Kam, FDA 
Gregory Levin, FDA 
Bo Li, FDA 
Sirisha Mushti, FDA 
Mat Soukup, FDA 
*Cesar Torres, FDA 
Therri Usher, FDA 
Jialu Zhang, 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.