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(Stroke. 1999;30:1165-1166.)
© 1999 American Heart Association, Inc.

Editorial

Clinical Stroke Trials

Guarding Against Bias

Larry B. Goldstein, MD; Thomas G. Brott, MD; Rashmi U. Kothari, MD Wade S. Smith, MD, PhD

From the Department of Medicine (Neurology), Center of Cerebrovascular Disease, Center for Clinical Health Policy Research, Duke University and the Durham VA Medical Center, Durham, NC (L.B.G.); Mayo Clinic, Jacksonville, Fla (T.G.B.); Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio (R.U.K.); and Department of Neurology, UCSF Stroke Service, University of California, San Francisco (W.S.S.).

Correspondence to Larry B. Goldstein, MD, Box 3651, Duke University Medical Center, Durham, NC 27710. E-mail golds004@mc.duke.edu

Key Words: bias • clinical trials • editorials • ethics, medical

Attendees at the recent 24th AHA International Joint Conference on Stroke and Cerebral Circulation were startled when an investigator of an industry-funded clinical trial selected for presentation took the podium to announce that he was being prevented from presenting the results of the study by the pharmaceutical company sponsor.¹ Although the data had apparently been held by the sponsor for an adequate period to allow careful review and analysis, permission to publicly disclose the results was withdrawn by the company's senior management the evening prior to the abstract presentation, purportedly based on concerns about the accuracy of the information. Because of contractual agreements with the investigators, the industry sponsor maintained a right to block public disclosure. Although we are not privy to the details of the circumstances prompting this episode, it may represent one of the most blatant recent examples of the potential negative side of academic-industry cooperation in the conduct of patient-based clinical research and has important legal, ethical, and scientific implications.

A contract between the investigators and the pharmaceutical company sponsor was cited as the justification for blocking the presentation of the study results. However, the American Heart Association abstract submission document was also signed and indicates that if accepted, the presentation will occur (and implicitly that time on the program will not be granted to another presentation), that it represents original work, and that there is no apparent conflict of interest. In addition, informed consent documents signed by patients (or their legal representatives) participating in clinical trials . . . [Full Text of this Article]

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