Adaptive Clinical Trials: Overview of Early-Phase Designs and Challenges

作者:Marchenko Olga*; Fedorov Valerii; Lee J Jack; Nolan Christy; Pinheiro Jose
来源:Therapeutic Innovation & Regulatory Science, 2014, 48(1): 20-30.
DOI:10.1177/2168479013513889

摘要

In this paper, the authors describe developments in adaptive design methodology and discuss implementation strategies and operational challenges in early-phase adaptive clinical trials. The BATTLE trialthe first completed biomarker-based Bayesian adaptive randomized study in lung canceris presented as a case study to illustrate main ideas and share learnings.

  • 出版日期2014-1