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Industry Influences Medical Research, Survey Reports
Academic institutions regularly engage in industry-sponsored research that falls short of the standards for research integrity established by medical journals, wrote the authors of a survey of U.S. medical schools published in the October 24, 2002, issue of the New England Journal of Medicine.
The standards against which the survey authors measured institutional practices are those of the International Committee of Medical Journal Editors, whose members include editors from the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine. The standards seek to ensure the soundness of clinical research findings published in such journals, on which physicians rely to treat patients and which influence public health policy.
The committee revised its guidelines for manuscript submissions to biomedical journals in September 2001 because of worries about the integrity of clinical trials in a research environment increasingly dominated by private drug companies. The survey's authors set out to determine whether academic institutions are adhering to the new requirements, which call for assurances that clinical investigators remain independent of their sponsors, fully accountable for the design and conduct of trials, have access to all trial data, and control publications and editorial decisions. They interviewed officials responsible for the content of research agreements at the 108 medical schools that participated in the study.
The authors found that academic institutions rarely ensure that their investigators participate fully in the design of trials, have access to all data produced, or preserve the right to publish their findings. The authors report that several of their respondents said they felt powerless in contract negotiations with sponsors. This finding validates the concern voiced by the International Committee of Medical Journal Editors in 2001 that academic investigators feel pressured to accept the draconian terms of drug companies because they know that if they do not, the sponsors will find someone else who will.
The survey authors conclude that the academic community needs to re-evaluate its approach to sponsorship of clinical trials to make sure that research is conducted in accordance with the medical journals' standards and the ethical obligations of research institutions.
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