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

Olga Marchenko; Valerii Fedorov; J. Jack Lee; Christy Nolan; José Pinheiro

doi:10.1177/2168479013513889

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

Olga Marchenko, Valerii Fedorov, J. Jack Lee, Christy Nolan, José Pinheiro

Biostatistics

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

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.

Original language	English (US)
Pages (from-to)	20-30
Number of pages	11
Journal	Therapeutic Innovation and Regulatory Science
Volume	48
Issue number	1
DOIs	https://doi.org/10.1177/2168479013513889
State	Published - Jan 2014

Keywords

adaptive design
clinical trial management
data monitoring committee
early-phase designs
modeling and simulation

ASJC Scopus subject areas

Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)

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KW - modeling and simulation

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

Abstract

Keywords

ASJC Scopus subject areas

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