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Activity Number: 307 - Clinical Trial Design-3
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #329800 Presentation
Title: Systematic Review of Test/Estimation Approach in Comparative Cancer Clinical Studies with Time-To-Event Outcomes
Author(s): Miki Horiguchi* and Hajime Uno
Companies: Kitasato University and Dana Farber Cancer Institute
Keywords: hazard ratio; logrank test; median survival time; restricted mean survival time; test/estimation coherency; t-year event rate

Two major analytic tasks in comparative clinical trials with time-to-event outcomes are 1) testing equality of treatment groups, and 2) estimating a primary summary of the treatment effect. We call the combination of statistical methods to address this two task a "test/estimation" approach. To identify potential opportunities to improve conventional analytic approaches, we analyzed the methods that are currently used in cancer clinical trials. We conducted a systematic review of the test/estimation methods used by recent cancer clinical trials. Specifically, focusing on oncology clinical research, we search papers reporting the results from phase III randomized clinical trials where either overall survival, progression-free survival, or disease-free survival was included as the primary or secondary endpoint. We search papers in seven major clinical journals. We classify the papers by the test/estimation approach and highlight pros and cons of those.

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

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