Integrity of Researchers Often at Risk in Clinical Trials

Failing to adhere to established guidelines regarding trial design, publication rights, and access to data may pose a variety of risks for research participants, say researchers at the Duke University Medical Center and Duke University School of Law (Durham, NC, USA; www.mc.duke.edu). They found that agreements between industry and medical centers often do not uphold the revised guidelines issued in October 2001 by the International Committee of Medical Journal Editors (ICMJE), used by more than 500 medical journals as a standard for submitting research papers for publication.

"We didn't expect to find full compliance with the guidelines, but we were surprised by the extent to which the agreements entered into by medical schools did not protect the independence of investigators in clinical studies and the integrity of their research,” said
Kevin A. Schulman, M.D., professor of medicine at Duke and lead author of the study.

The Duke researchers surveyed 108 member institutions of the Association of American Medical Colleges to assess the extent to which their contracts with clinical trial sponsors complied with the three main provisions of the guidelines: that authors of reports of multicenter trials should have access to all trial data, that the authors or an independent committee should control editorial and publication decisions, and that investigators should be fully involved in the design and conduct of the trials. They found that agreements rarely included such provisions. In fact, only 1% of agreements required that authors of reports from multicenter studies have independent access to all data from the trial.

Also, industry sponsors typically control decisions regarding the publication of data from clinical trials. Provisions addressing editorial control of multicenter manuscripts appeared in 40% of contracts, but an independent publications committee and a guarantee of publication were specified in less than 1% of contracts. Also, only 2% required the presence of an independent executive committee as a condition of participation in a trial, and only 1% required a data and safety monitoring board.




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