Adaptive designs from a Data Safety Monitoring Board perspective: Some controversies and some case studies.
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.
1 School of Operations Research and Information Engineering, Cornell University, Ithaca, NY, USA.
Bruce W
BW
Turnbull
D001499:Bayes Theorem; D026661:Clinical Trials Data Monitoring Committees; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D015195:Drug Design; D023381:Endpoint Determination / Q000941:ethics* / Q000379:methods; D006801:Humans; D012107:Research Design / Q000592:standards*; D018401:Sample Size
Adaptive design; enrichment design; flexible design; group-sequential test; multi-arm multi-stage trial; optimal design; promising zone; sample size re-estimation; seamless Phase II/III design