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

Ther Innov Regul Sci

Quantitative Decision Strategies, Janssen Research & Development, LLC.

Published: January 2014

In this paper, we 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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5489916PMC
http://dx.doi.org/10.1177/2168479013513889DOI Listing

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