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

Overview

Journal Ther Innov Regul Sci

Specialties General Medicine
Pharmacology

Date 2017 Jul 4

PMID 28670507

Citations 4

Authors

Olga Marchenko

Valerii Fedorov

J Jack Lee

Christy Nolan

Jose Pinheiro

Affiliations

Soon will be listed here.

Abstract

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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