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@wpo.iupui.edu
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
© 1998 American Heart Association, Inc.
Editorials
Ethics in Clinical Trials
Introduction
Key Words: clinical trials • editorials • ethics