Journal of Probability and Statistics
Volume 2012 (2012), Article ID 527351, 20 pages
http://dx.doi.org/10.1155/2012/527351
Review Article

Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials

Zhengjia Chen,1,2 Yichuan Zhao,3 Ye Cui,3 and Jeanne Kowalski1

1Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA 30322, USA
2Winship Cancer Institute, Emory University, 1365-B Clifton Road, Room B4109, Atlanta, GA 30322, USA
3Department of Mathematics and Statistics, Georgia State University, Atlanta, GA 30303, USA

Received 29 June 2012; Revised 8 October 2012; Accepted 9 October 2012

Academic Editor: Xuelin Huang

Copyright © 2012 Zhengjia Chen et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The clinical trial, a prospective study to evaluate the effect of interventions in humans under prespecified conditions, is a standard and integral part of modern medicine. Many adaptive and sequential approaches have been proposed for use in clinical trials to allow adaptations or modifications to aspects of a trial after its initiation without undermining the validity and integrity of the trial. The application of adaptive and sequential methods in clinical trials has significantly improved the flexibility, efficiency, therapeutic effect, and validity of trials. To further advance the performance of clinical trials and convey the progress of research on adaptive and sequential methods in clinical trial design, we review significant research that has explored novel adaptive and sequential approaches and their applications in Phase I, II, and III clinical trials and discuss future directions in this field of research.