Reports of randomized trials in acute stroke, 1955 to 1995 - What proportions were commercially sponsored?

Background and Purpose-Research in acute stroke has expanded rapidly. Many potentially important interventions lack commercial potential (eg, admissio n to a stroke unit). We therefore wished to examine the frequency of report s of randomized trials of interventions for acute stroke over the past 40 y ears, the source of support for such trials, the reporting of the commercia l involvement, and whether the proportion of commercially supported trials had changed. Methods-Eligible trials were identified from the Cochrane Stroke Group's sp ecialized register of controlled clinical trials. We included all randomize d trials in patients with acute stroke which published a full text report, in English, between 1955 and 1995. Two reviewers independently extracted da ta on the involvement of the pharmaceutical industry in all eligible trials . Results-There was a substantial increase in the number of acute stroke tria ls published per year between 1955 and 1995. The description of pharmaceuti cal 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 pharmaceutica l 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 b e in the interests of public health. Poor reporting of the sponsor's involv ement suggests that modifications to the guidelines for the reporting of ra ndomized controlled trials to include more details of the sponsor's involve ment in the design, conduct, management, analysis, and reporting of the tri al are justified.