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(Stroke. 1998;29:1491-1492.)
© 1998 American Heart Association, Inc.

Editorials

Ethics in Clinical Trials

Progress ni Acute Stroke Research

John R. Marler, MD; Michael D. Walker, MD

From the Division of Stroke, Trauma and Neurodegenerative Disorders, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, Md.

Correspondence to John R. Marler, MD, Division of Stroke, Trauma and Neurodegenerative Disorders, NIH, NINDS, Room 8A08, Federal Building, 7550 Wisconsin Ave, Bethesda, MD 20892. E-mail marlerj@ninds.nih.gov

Key Words: clinical trials • editorials • ethics

We are delighted to respond to Dr Slyter's¹ commentary on acute stroke research. At the outset, we would like to state that stroke research is critically important for improving the health of the public, that many important clinical questions cannot be answered without clinical trials, and that the NINDS and stroke investigators are committed to protecting those who choose to participate in clinical research. Dr Slyter voices specific concerns about early phase 1 studies that offer no therapeutic benefit to the patient. He is also concerned about how to treat patients assigned to the control group in a randomized trial when there is widespread controversy about standard care, which may be as much a medical issue as an ethical one.

Dr Slyter questions the management of blood pressure in the NINDS rt-PA Stroke Trial. In fact, management of blood pressure in the trial was designed with careful consideration of the patients in both the placebo and active treatment arms of the trial. The reader may wish to read the references concerning the treatment of blood pressure cited by Dr Slyter. As he himself states, there is very little data and a great deal of controversy regarding this issue. Physicians must form their own opinions after reading the reports he cites in support of his arguments. In addition, in this issue of Stroke, the NINDS rt-PA Stroke Trial investigators report on an analysis of data that will provide the reader with more insight into the limits placed on the management of . . . [Full Text of this Article]

This article has been cited by other articles:

				G. W. Albers, J. A. Zivin, and D. W. Choi Ethics in Clinical Trials : Response to Ethical Challenges in Stroke Research Stroke, August 1, 1998; 29(8): 1492 - 1493. [Full Text]

				G. W. Albers, J. A. Zivin, and D. W. Choi Ethics in Clinical Trials : Ethical Standards in Phase 1 Trials of Neuroprotective Agents for Stroke Therapy Stroke, August 1, 1998; 29(8): 1493 - 1494. [Full Text]

				J. R. Marler and M. D. Walker Ethics in Clinical Trials : Progress ni Acute Stroke Research Stroke, August 1, 1998; 29 (8): 1491 - 1492. [Full Text]