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" and whether the clinical
problem being addressed is a "burning issue." It appears, however,
that in the current financial climate of academic medical centers in
the United States, science is taking a backseat to dollars in some
instances.
References
1.
Saver JL. Coping with an embarrassment of
riches: how stroke centers may participate in multiple, concurrent
clinical stroke trials. Stroke.. 1995;26:1289–1292.
2.
Halliday AW. The Asymptomatic Carotid
Surgery Trial (ACST): rationale and design. Eur J Vasc
Surg.. 1994;8:703–710.[Medline]
[Order article via Infotrieve]
© 1998 American Heart Association, Inc.
Letters to the Editor
Clinical Trials and Financial Reimbursement
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