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Editorial
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Volume 348:1377-1380 April 3, 2003 Number 14
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Controlling Research Trials
Jeffrey M. Drazen, M.D.

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Clinical research, especially in the form of large multicenter trials, promotes changes in practice; without the accrual of new knowledge, clinical care will not advance. A deadlock between the National Heart, Lung, and Blood Institute (NHLBI) and the Office of Human Research Protections (OHRP) of the Department of Health and Human Services about the ethics of a clinical trial has the potential to bring much clinical research to a halt. The trial in question is designed to examine the ability of intravenous-fluid management directed by physiological data obtained from a pulmonary-artery catheter to influence outcomes in medical intensive care units. . . . [Full Text of this Article]


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Dr. Drazen serves as a member of the National Heart, Lung, and Blood Institute Advisory Council.


Related Letters:

Protection of Research Subjects
Kaufman J. L., Bateman B. T., Meyers P. M., Schumacher H. C., Berger J. T., Karlawish J. H.T., Campbell D. J., Karnad A., Sudbo J., Miller F. G., Rosenstein D. L., Tremaine W. J., Noble J. H. Jr., Sharav V. H., Pesando J. M., Drazen J. M.
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N Engl J Med 2003; 349:188-192, Jul 10, 2003. Correspondence

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