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(Stroke. 1999;30:1995-1998.)
© 1999 American Heart Association, Inc.

Original Contributions

Reports of Randomized Trials in Acute Stroke, 1955 to 1995

What Proportions Were Commercially Sponsored?

Paul J. Dorman, MRCP, MD; Carl Counsell, MRCP, MD Peter Sandercock, MD, FRCP

From the Department of Neurology, Regional Neurosciences Centre, Newcastle General Hospital, Newcastle upon Tyne, (P.D.), and the Department of Neurology, Western General Hospital, Edinburgh, UK (C.C., P.S.).

Correspondence to Dr Paul Dorman, Department of Neurology, Regional Neurosciences Centre, Newcastle General Hospital, Westgate Road, Newcastle on Tyne NE4 6BE, UK.

Background and Purpose—Research in acute stroke has expanded rapidly. Many potentially important interventions lack commercial potential (eg, admission to a stroke unit). We therefore wished to examine the frequency of reports of randomized trials of interventions for acute stroke over the past 40 years, the source of support for such trials, the reporting of the commercial involvement, and whether the proportion of commercially supported trials had changed.

Methods—Eligible trials were identified from the Cochrane Stroke Group's specialized register of controlled clinical trials. We included all randomized trials in patients with acute stroke which published a full text report, in English, between 1955 and 1995. Two reviewers independently extracted data on the involvement of the pharmaceutical industry in all eligible trials.

Results—There was a substantial increase in the number of acute stroke trials published per year between 1955 and 1995. The description of pharmaceutical industry involvement in each trial report was poor. Only a minority of supported trials made explicit statements about the role of the sponsoring company. The proportion of trials apparently supported by the pharmaceutical industry has increased substantially.

Conclusions—The increasingly important role of the pharmaceutical industry in evaluating new treatments gives substantial scope for bias and may not be in the interests of public health. Poor reporting of the sponsor's involvement suggests that modifications to the guidelines for the reporting of randomized controlled trials to include more details of the sponsor's involvement in the design, conduct, management, analysis, and reporting of the trial are justified.

Key Words: controlled clinical trials • drug industry • research support • systematic review

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