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

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...

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Main Authors: Zhengjia Chen, Yichuan Zhao, Ye Cui, Jeanne Kowalski
Format: Article
Language:English
Published: Wiley 2012-01-01
Series:Journal of Probability and Statistics
Online Access:http://dx.doi.org/10.1155/2012/527351
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author Zhengjia Chen
Yichuan Zhao
Ye Cui
Jeanne Kowalski
author_facet Zhengjia Chen
Yichuan Zhao
Ye Cui
Jeanne Kowalski
author_sort Zhengjia Chen
collection DOAJ
description 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.
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spelling doaj-art-c3fade74e991497d9b874f3bf0587c232025-08-20T02:18:56ZengWileyJournal of Probability and Statistics1687-952X1687-95382012-01-01201210.1155/2012/527351527351Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical TrialsZhengjia Chen0Yichuan Zhao1Ye Cui2Jeanne Kowalski3Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA 30322, USADepartment of Mathematics and Statistics, Georgia State University, Atlanta, GA 30303, USADepartment of Mathematics and Statistics, Georgia State University, Atlanta, GA 30303, USADepartment of Biostatistics and Bioinformatics, Emory University, Atlanta, GA 30322, USAThe 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.http://dx.doi.org/10.1155/2012/527351
spellingShingle Zhengjia Chen
Yichuan Zhao
Ye Cui
Jeanne Kowalski
Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials
Journal of Probability and Statistics
title Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials
title_full Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials
title_fullStr Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials
title_full_unstemmed Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials
title_short Methodology and Application of Adaptive and Sequential Approaches in Contemporary Clinical Trials
title_sort methodology and application of adaptive and sequential approaches in contemporary clinical trials
url http://dx.doi.org/10.1155/2012/527351
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AT yichuanzhao methodologyandapplicationofadaptiveandsequentialapproachesincontemporaryclinicaltrials
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AT jeannekowalski methodologyandapplicationofadaptiveandsequentialapproachesincontemporaryclinicaltrials