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Research institutions fail to adhere to clinical trial guidelines, study finds

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DURHAM, N.C. — Academic institutions routinely engage in industry-sponsored research “that fails to adhere to the International Committee of Medical Journal Editors’ guidelines” regarding trial design, access to data and publication rights, asserts a study published in the New England Journal of Medicine. The study authors suggest a reevaluation of the process of contracting for clinical research.

Researchers here with the Center for Clinical and Genetic Economics at Duke University interviewed officials at 108 medical schools to determine how many complied with the guidelines issued by the International Committee of Medical Journal Editors (ICMJE). Scores for compliance with a wide range of provisions — from ensuring that authors of reports on multicenter trials have access to all trial data to addressing the plan for data collection and monitoring — demonstrated limited adherence to the standards embodied in the ICMJE guidelines.