Boston MA Approximately 70 percent of clinical drug trials in the U.S. are funded by industry sponsors. A survey of academic medical centers found that some have more stringent standards than others regarding the aspects of research that industry sponsors are permitted to control for example, whether sponsors can limit access to data or prohibit investigators from discussing research results. Michelle Mello, associate professor of health policy and law at the Harvard School of Public Health, and colleagues examined medical school research administrators' standards for the clinical trial contracts established with industry sponsors. The findings appear in the May 26, 2005 issue of the New England Journal of Medicine.

Detailed questionnaires, including questions about 17 specific contractual provisions restricting investigators' control over clinical trials, were sent to all 122 accredited medical schools in the U.S. A total of 107 administrators from medical school offices of sponsored research completed the survey. More than half of the respondents handled 100 or more clinical trial agreements per year.

On some issues, research administrators agreed about what was ethically acceptable. Eighty-nine percent said they would not permit an industry sponsor to revise a manuscript written by academic investigators (other than revisions to protect proprietary information), 93 percent found it unacceptable to allow sponsors to decide that research results should not be published, and 96 percent would allow industry sponsors to review manuscripts for a limited time prior to publication, with 60 days being the most widely accepted maximum review period. Two thirds of the schools would let sponsors prohibit investigators from discussing ongoing clinical trials, but the same proportion would disallow this prohibition once the trial was over.

On other issues, there was wide divergence in medical schools' standards. Asked whether or not sponsors shou
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Contact: Kevin C. Myron
kmyron@hsph.harvard.edu
617-432-3952
Harvard School of Public Health
25-May-2005

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