alexa A General Overview of Adaptive Randomization Design for Clinical Trials
ISSN: 2155-6180

Journal of Biometrics & Biostatistics
Open Access

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Review Article

A General Overview of Adaptive Randomization Design for Clinical Trials

Jianchang Lin1*, Li-An Lin2 and Serap Sankoh1

1Takeda Pharmaceutical Company Limited, Cambridge, MA, USA

2Merck Research Laboratories, Whitehouse Station, New Jersey , USA

*Corresponding Author:
Jianchang Lin
Takeda Pharmaceutical Company Limited
Cambridge, MA, USA
Tel: +1-617-679-7000
E-mail: [email protected]

Received Date: March 25, 2016; Accepted Date: April 14, 2016; Published Date: April 21, 2016

Citation: Lin J, Lin LA, Sankoh S (2016) A General Overview of Adaptive Randomization Design for Clinical Trials. J Biom Biostat 7:294. doi:10.4172/2155-6180.1000294

Copyright: © 2016 Lin J, et al.This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

With the recent release of FDA draft guidance (2010), adaptive designs, including adaptive randomization (e.g. response-adaptive (RA) randomization) has become popular in clinical trials because of its advantages of flexibility and efficiency gains, which also have the significant ethical advantage of assigning fewer patients to treatment arms with inferior outcomes. In this paper, we presented a general overview of adaptive randomization designs for clinical trials, including Bayesian and frequentist approaches as well as response-adaptive randomization. Examples were used to demonstrate the procedure for design parameters calibration and operating characteristics. Both advantages and disadvantages of adaptive randomization were discussed in the summary from practical perspective of clinical trials.

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