(Stroke. 1998;29:1491.)
© 1998 American Heart Association, Inc.
Ethics in Clinical Trials
Introduction
José Biller, MD
From the Department of Neurology, Indiana University, Indianapolis, Ind.
Correspondence to José Biller, MD, Department of Neurology, Indiana University, Emerson Hall 125, 545 Barnhill Dr, Indianapolis, IN 46202-5124. E-mail jbiller{at}wpo.iupui.edu
Key Words: clinical trials • editorials • ethics
This issue of
Stroke includes a scientific article, a commentary, and
three editorials which, taken as a whole, present a forum
discussing a vitally important issue, ethics in clinical stroke trials.
Our Editor-in-Chief has asked that I introduce these editorials and
articles.
We have made considerable progress in recent years in unraveling
the first layers of the complexities of well-designed and well-executed
clinical trials in stroke. However, with this progress comes the
realization that the puzzle is even more complex than we expected.
These articles discuss some of these complexities.
The review article by Slyter1 brings new
viewpoints and concerns about acute stroke trials from sources other
than "stroke experts."
To keep Dr Slyter's comments in perspective, we invited John Marler
and Michael Walker, from the Medical Office of the National Institutes
of Health, to address ethical issues in stroke trials in general and
the NINDS rt-PA Stroke Trial in particular.2
The short editorial by Haley3 responds to some of
the comments made by Slyter1 regarding management
of hypertension in the NINDS trials.
In addition, the editorial of Albers et al4 adds
commentary about trials of neuroprotective agents for stroke
therapy from the vantage point of the; director of a
major stroke treatment center. This article discusses many of Dr
Slyter's recommendations regarding phase 1 trials.
And finally, Brott et al,5 for the NINDS
rt-PA Stroke Study Group, contribute a report on the frequency, course,
and treatment of hypertension in the NINDS Stroke Trial.
Coincidentally, this report addresses some of Dr
Slyter's1 concerns.
We believe our readers will find these articles thought provoking and
informative. We hope that they will help foster well-designed and
ethically conducted trials which pursue better outcomes for stroke
patients, the real goal of progress in our field.
Footnotes
The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association.
References
-
Slyter H. Ethical challenges in stroke research.
Stroke. 1998;29:1725–1729.
-
Marler JR, Walker MD. Progress in acute stroke
research. Stroke.. 1998;29:1491–1492. Editorial.
-
NINDS rt-PA Stroke Study Group. Response to ethical
challenges in stroke research Stroke. 1998;29:1492–1493.
Editorial.
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Albers GW, Ziven JA, Choi DW. Ethical standards in
phase 1 trials of neuroprotective agents for stroke therapy.
Stroke.. 1998;29:1493–1494. Editorial.
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Brott T, Lu M, Fagan S, Kothari R, Frankel M, Grotta
JC, Broderick J, Kwiatkowski T, Lewandowski C, Haley EC, Marler JR,
Tilley BC, for the NINDS rt-PA Stroke Study Group. Hypertension and its
treatment in the NINDS rt-PA Stroke Trial. Stroke. 1998;29:1504–1509.
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Federal Register, Part III, Department of Health, and
Human Services, Food, and Drug Administration. 21 CFR Part 30 et al,
Protection of Human Subjects; Informed Consent; Proposed rule,
Thursday, September 21, 1995.
-
The National Institutes of Neurological Disorders and
Stroke rt-PA Stroke Study Group. Tissue plasminogen
activator for acute ischemic stroke. N
Engl J Med. 1995;333:1581–1587.
