555 – Bayesian Modeling: Application in Clinical Trial Design and Analysis
Application of Resampling Method in Futility Analysis Based on Multiple Studies
Annpey Pong
Merck
Jingshan Zhang
Celgene Corporation
Jun Zhao
Merck
In late stage drug development, it is common to conduct multiple studies simultaneously in a development program in order to fulfill regulatory filing requirements as early as possible. However, the design elements such as sample sizes and corresponding powers are determined based on information from past studies at earlier phases. In addition, the assumptions may vary in terms of timing or conditions of conducting these new studies. Considering limited resource, the futility analysis is usually to be considered at interim to stop a study or a program early if the expected probability of success is relatively low. In this research work, a resampling method is proposed to assess the expected probability of success when a futility evaluation of multiple studies is performed in an interim analysis in a development program.
