Adaptive designs from a Data Safety Monitoring Board perspective: Some controversies and some case studies

Abstract

This article describes vignettes concerning interactions with Data Safety Monitoring Boards during the design and monitoring of some clinical trials with an adaptive design. Most reflect personal experiences by the author.

Keywords

Adaptive design group-sequential test sample size re-estimation flexible design optimal design promising zone enrichment design multi-arm multi-stage trial seamless Phase II/III design

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