Adaptive Clinical Trials: Overview of Early-Phase Designs and Challenges. (January 2014)

• Record Type: Journal Article
• Authors: Marchenko, Olga; Fedorov, Valerii; Lee, J. Jack; Nolan, Christy; Pinheiro, José
• Is Part Of: Therapeutic innovation & regulatory science. Volume 48:Number 1(2014:Jan.)
• Page Start: 20
• Page End: 30
• Publication Date: 2014-01
• Subjects: adaptive design -- early-phase designs -- clinical trial management -- data monitoring committee -- modeling and simulation; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479013513889
• Languages: English
• ISSNs: 2168-4790

Abstract

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 trial—the first completed biomarker-based Bayesian adaptive randomized study in lung cancer—is presented as a case study to illustrate main ideas and share learnings.