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

作者：Turnbull Bruce W^*

来源：Clinical Trials, 2017, 14(5): 462-469.

DOI：10.1177/1740774516689261

• 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

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.

• 出版日期2017-10