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
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.
The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association.
- Copyright © 1998 by American Heart Association
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.
Albers GW, Ziven JA, Choi DW. Ethical standards in phase 1 trials of neuroprotective agents for stroke therapy. Stroke.. 1998;29:1493–1494. Editorial.
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.
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.