T-42: Sample Size Re-Estimation in Action: Design Consideration, Charter Development, and Implementation of Analyses in a Trial with Adaptive Components

Poster Presenter

Adam Hamm

Senior Vice President, Biostatistics and Strategic Consulting
Statistics & Data Corporation (SDC)
United States

Objectives

This abstract presents a case study for a sample size re-estimation "in action" and provides opinions on best clinical and statistical practices for studies with a sample size re-estimation.

Method

This study is a phase 3 study with an adaptive design, ongoing as of January 2019. Materials to be used and included include clinical and statistical plans.

Results

The primary endpoint is a survival endpoint (death before a certain study day) in a trial with cardiovascular endpoints. The trial has not completed yet but aspects pertaining to the poster objectives will be available by the time of the poster presentation at DIA 2019.

Conclusion

From the poster presentation, the author hopes to present beneficial practices for conducting and analyzing a trial with adaptive components, specifically a sample size re-estimation.