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(Stroke. 1998;29:1492-1493.)
© 1998 American Heart Association, Inc.

Editorials

Ethics in Clinical Trials

Response to Ethical Challenges in Stroke Research

The NINDS rt-PA Stroke Study Group
Gregory W. Albers, MD; Justin A. Zivin, MD, PhD; Dennis W. Choi, MD, PhD

From the Department of Neurology, University of Virginia Health System, Charlottesville, Va.

Correspondence to E. Clarke Haley, Jr, MD, Box 394, Department of Neurology, University of Virginia Health System, Charlottesville, VA 22908. E-mail ech@virginia.edu

Key Words: clinical trials • editorials • ethics

Dr Slyter¹ raises a number of important points. Investigational drug trials are ultimately the result of a complex scientific and ethical balancing act very familiar to the investigators involved in the studies that Dr Slyter cites. It is unfortunate that new treatments cannot be developed without risk, but we do not believe that the principle of "do no harm" should be translated into "make no attempt to help unless risks can be eliminated." Virtually all forms of treatment involve risks. A physician's role is to try to assess the benefit-to-risk ratio. Most commonly accepted therapies can have side effects ranging from serious injury to death, and many patients do not respond to a given form of treatment. If avoiding harm was the only objective of physicians, it would be a logically defensible position that we should not treat anyone.

The purpose of a phase 1 trial is not to prove the efficacy of a new agent, and one can predict with near certainty that some patients will suffer adverse events. This is inevitable in almost any drug development program, because the tolerability limits of a new form of treatment must be explored to define its safety profile. Initial estimates are derived from preclinical testing, but the final determination must come from human studies. It is not more ethical to expose healthy volunteers to potential side effects than to conduct these trials in patients who have at least the possibility of benefit from the investigational agent. The safety problems encountered in . . . [Full Text of this Article]

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