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Activity Number: 114
Type: Topic Contributed
Date/Time: Monday, August 1, 2016 : 8:30 AM to 10:20 AM
Sponsor: Committee on Career Development
Abstract #321264 View Presentation
Title: Effect of Differential Discontinuations Across Treatment Arms on Survival Estimates in Randomized Clinical Trials
Author(s): Shanti Gomatam*
Companies: FDA
Keywords: Treatment discontinuation ; Safety ; hazard ratio
Abstract:

Differential discontinuations across treatment arms in a randomized clinical trial can potentially bias the estimate of the treatment effect. In this work we study the effect of varying parameters (level and pattern of discontinuation, size of treatment effect etc.) on survival estimates in the safety context. Specifically, we study the effect of varying different simulation parameters, in a structured and systematic manner, on the hazard ratio estimates for time-to-event endpoints.


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

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