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(Stroke. 1998;29:1256.)
© 1998 American Heart Association, Inc.


Letters to the Editor

Clinical Trials and Financial Reimbursement

Seemant Chaturvedi, MD

Department of Neurology, Wayne State University, Detroit, Michigan, United States Coordinator, ACST

To the Editor:

Randomized clinical trials are the current "gold standard" for scientifically establishing the effectiveness of new therapies in medicine. Clinical investigators choose to participate in research studies for several reasons. The reasons are not mutually exclusive, and they include the following: (1) contribution to medical advances, (2) academic recognition, and (3) financial renumeration.1

The Asymptomatic Carotid Surgery Trial (ACST) is an international clinical trial evaluating the effectiveness of carotid endarterectomy for the prevention of stroke in patients with asymptomatic carotid artery stenosis.2 As part of the trial's recent expansion to sites in North America, 60 leading academic neurology centers in the United States were invited to join the study. Representatives from 32 centers (53%) responded to the initial mailing and sought additional information regarding the trial. Two centers declined to participate on the basis of concerns regarding measurement of carotid stenosis. The majority of centers refused to join the study because of the lack of any per patient financial reimbursement. One center commented that they were looking for the clinical trial that would deliver "the golden egg."

These responses from preeminent neurological academic programs led me to the following conclusions: (1) there is considerable uncertainty regarding the value of carotid endarterectomy for asymptomatic stenosis among US stroke specialists, and (2) decisions regarding which clinical trials to participate in are to a large extent based on the potential for financial rewards. Ideally, one would hope that clinicians would participate in a clinical research study on the basis of "science" . . . [Full Text of this Article]




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