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

被引：10

作者：

Marchenko, Olga ^{[1
]}

Fedorov, Valerii ^{[2
]}

Lee, J. Jack ^{[3
]}

Nolan, Christy ^{[4
]}

Pinheiro, Jose ^{[5
]}

机构：

[1] Quintiles Inc, Ctr Stat Drug Dev, Innovat, Durham, NC 27703 USA

[2] Quintiles Inc, Predict Analyt, Innovat, Durham, NC 27703 USA

[3] Univ Texas MD Anderson Canc Ctr, Dept Biostat, Div Quantitat Sci, Houston, TX 77030 USA

[4] Quintiles Inc, Innovat, Durham, NC 27703 USA

[5] Janssen Res & Dev LLC, Quantitat Decis Strategies, Raritan, NJ USA

来源：

THERAPEUTIC INNOVATION & REGULATORY SCIENCE | 2014年 / 48卷 / 01期

关键词：

adaptive design; early-phase designs; clinical trial management; data monitoring committee; modeling and simulation; BATTLE TRIAL; LUNG-CANCER; RANDOMIZATION; EFFICACY; DRUG; STRATEGIES; THERAPY; MODELS;

D O I：

10.1177/2168479013513889

中图分类号：

R-058 [];

学科分类号：

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.

引用

页码：20 / 30

页数：11

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