M&M: A maximum duration design with the Maxcombo test for a group sequential trial of an immunotherapy with a random delayed treatment effect

Published: Nov 15, 2021
Abstract
A random delayed treatment effect is expected in a confirmatory clinical trial for an immunotherapy due to the individual heterogeneity of physiological conditions. For this reason, the delay time will be assumed to follow a continuous distribution that is difficult to estimate accurately based on the early-phase data, which hinders the specification of the most powerful weighted log-rank test. Therefore, we propose a simulation-based maximum...
Paper Details
Title
M&M: A maximum duration design with the Maxcombo test for a group sequential trial of an immunotherapy with a random delayed treatment effect
Published Date
Nov 15, 2021
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