Optimizing Trial Design: Sequential, Adaptive, and Enrichment Strategies

Ping Gao, Cyrus R. Mehta and James H. Ware

Circulation, a Taylor & Francis Group publication, 2008 

Abstract: Because the clinical development process is enormously expensive and time consuming, there is considerable interest in statistical methods that use accumulating data from a clinical trial to inform and modify its design. Such redesign might include changes in target sample size and even changes in the target population. This article discusses developments in adaptive design of interest to cardiovascular research.