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Activity Number: 115 - Novel Statistical Methods for Emerging Problems in Modern Clinical Trials and Drug Development
Type: Topic Contributed
Date/Time: Monday, July 29, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #306973
Title: Robust Clinical Trial Design and Analysis When Non-Proportional Hazards Are Likely
Author(s): Keaven Anderson*
Companies: Merck & Company, Inc.
Keywords: clinical trials; non-proportional hazards; design; weighted logrank

The Non-Proportional Hazards Working Group (NPHWG) is an industry group formed following discussions with the FDA in 2016. The group has focused on finding a testing strategy that is robust to various alternatives particularly including both proportional hazards and delayed effects. We will discuss advantages and disadvantages of a combination test approach to design and analysis. Also, we include both asymptotic and simulation tools to evaluate such designs. Finally, we contrast the robust testing approach to other approaches such as the RMST or generalized pairwise comparisons that have corresponding estimands that are easily interpretable. The robust testing approach may be particularly useful quickly progressing disease such as metastatic cancer.

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

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