4.3 Article

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

Journal

CLINICAL TRIALS
Volume 14, Issue 5, Pages 462-469

Publisher

SAGE PUBLICATIONS LTD
DOI: 10.1177/1740774516689261

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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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.

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