Clinical research, especially in the form of large multicentertrials, promotes changes in practice; without the accrual ofnew knowledge, clinical care will not advance. A deadlock betweenthe National Heart, Lung, and Blood Institute (NHLBI) and theOffice of Human Research Protections (OHRP) of the Departmentof Health and Human Services about the ethics of a clinicaltrial has the potential to bring much clinical research to ahalt. The trial in question is designed to examine the abilityof intravenous-fluid management directed by physiological dataobtained from a pulmonary-artery catheter to influence outcomesin 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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