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Activity Number: 416 - Clinical Trial Design- 4
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #329161 Presentation
Title: Analysis of Stratified Clinical Trials with Time-To-Event Endpoints
Author(s): Devan V Mehrotra* and Shanjun Helian and Shu-Chih Su
Companies: Merck & Co., Inc. and Merck & Co., Inc. and Merck Research Labs
Keywords: biomarker; Cox model; interaction; logrank test; stratification; survival analysis

Stratified randomization based on prognostic factor(s) is commonly used in comparative clinical trials. We will discuss two topics for such settings, with a focus on time-to-event endpoints: (i) estimation and inference for the "overall" (i.e., averaged across all patients) treatment effect, and (ii) assessment of whether the treatment effect is consistent across strata. Traditional methods (e.g., stratified Cox model) and proposed alternative approaches will be contrasted with illustrative examples and simulations, the latter used to quantify the effect on bias, type 1 error and power.

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

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