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The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials

The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials Opinion The Imperative of Overcoming Barriers VIEWPOINT to the Conduct of Large, Simple Trials Randomized clinical trials remain the most reliable also be excessive, and this too adds to the cost. Accord- Zubin J. Eapen, MD, MHS means of identifying the drugs, devices, and treatment ing to the Tufts Center for the Study of Drug Develop- Duke Clinical Research strategies that will improve human health. There is in- ment, the typical clinical trial in 2012 involved 13 end Institute, Durham, creasing interest in the possibility that “personalized” points, 169 case report form pages, and 175 days of on- North Carolina. medicine can be evaluated in much smaller trials be- site monitoring. cause the average treatment effect is expected to be Third, for most therapies, studies must be random- Michael S. Lauer, MD Office of the Director of larger in highly selected cohorts. Smaller, biomarker- ized. Estimates of effect size in large observational stud- the Division of driven trials can provide major insights into whom to ies may be precise but remain fundamentally ham- Cardiovascular treat and may be sufficient for selected disease states pered by bias and confounding that can be controlled Sciences of the in which considerable treatment http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials

Eapen, Zubin J.; Lauer, Michael S.; Temple, Robert J.
JAMA , Volume 311 (14) – Apr 9, 2014
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References (6)

Publisher
American Medical Association
Copyright
Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2014.1030
pmid
24715072
Publisher site
See Article on Publisher Site

Abstract

Opinion The Imperative of Overcoming Barriers VIEWPOINT to the Conduct of Large, Simple Trials Randomized clinical trials remain the most reliable also be excessive, and this too adds to the cost. Accord- Zubin J. Eapen, MD, MHS means of identifying the drugs, devices, and treatment ing to the Tufts Center for the Study of Drug Develop- Duke Clinical Research strategies that will improve human health. There is in- ment, the typical clinical trial in 2012 involved 13 end Institute, Durham, creasing interest in the possibility that “personalized” points, 169 case report form pages, and 175 days of on- North Carolina. medicine can be evaluated in much smaller trials be- site monitoring. cause the average treatment effect is expected to be Third, for most therapies, studies must be random- Michael S. Lauer, MD Office of the Director of larger in highly selected cohorts. Smaller, biomarker- ized. Estimates of effect size in large observational stud- the Division of driven trials can provide major insights into whom to ies may be precise but remain fundamentally ham- Cardiovascular treat and may be sufficient for selected disease states pered by bias and confounding that can be controlled Sciences of the in which considerable treatment

Journal

JAMA – American Medical Association

Published: Apr 9, 2014

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