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Adaptive Trials in Clinical Research

Adaptive Trials in Clinical Research VIEWPOINT Scientific and Ethical Issues to Consider Scientific Validity Rieke van der Graaf, PhD There are concerns that the validity and integrity of adap- Kit C. B. Roes, PhD 2,6 tive trials may be difficult to maintain. One concern is that Johannes J. M. van Delden, MD, PhD blinding cannot be fully maintained and interim results can- not be kept fully confidential from those involved with the NTEREST IN THE USE OF ADAPTIVE TRIAL DESIGN HAS IN- study. For instance, to make modifications to the study de- creased among clinical investigators, pharmaceutical sign, data need to be analyzed on an interim basis, and these companies, and regulatory authorities. Adaptive trials interim results may influence decisions of the data and safety Iare randomized clinical trials that allow for adapta- 7 monitoring boards, researchers, and study participants. An- tions in the study design while the study is being con- other concern is that accrual bias may occur. As the trial ducted. Modifications as a study is being conducted can in- progresses, researchers may be able to guess to which study clude changes in sample size, adjustments in medication group the next participant will be allocated. Accordingly, dosage, or changes in the http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Adaptive Trials in Clinical Research

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Publisher
American Medical Association
Copyright
Copyright 2012 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.6380
pmid
22692169
Publisher site
See Article on Publisher Site

Abstract

VIEWPOINT Scientific and Ethical Issues to Consider Scientific Validity Rieke van der Graaf, PhD There are concerns that the validity and integrity of adap- Kit C. B. Roes, PhD 2,6 tive trials may be difficult to maintain. One concern is that Johannes J. M. van Delden, MD, PhD blinding cannot be fully maintained and interim results can- not be kept fully confidential from those involved with the NTEREST IN THE USE OF ADAPTIVE TRIAL DESIGN HAS IN- study. For instance, to make modifications to the study de- creased among clinical investigators, pharmaceutical sign, data need to be analyzed on an interim basis, and these companies, and regulatory authorities. Adaptive trials interim results may influence decisions of the data and safety Iare randomized clinical trials that allow for adapta- 7 monitoring boards, researchers, and study participants. An- tions in the study design while the study is being con- other concern is that accrual bias may occur. As the trial ducted. Modifications as a study is being conducted can in- progresses, researchers may be able to guess to which study clude changes in sample size, adjustments in medication group the next participant will be allocated. Accordingly, dosage, or changes in the

Journal

JAMAAmerican Medical Association

Published: Jun 13, 2012

References