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proprietary information), 93 percent found it unacceptable to allow sponsors to decide that research results should not be published, and 96 percent would allow industry sponsors to review manuscripts for a limited time prior to publication, with 60 days being the most widely accepted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 should be allowed to draft manuscripts reporting research results and limit the role of academic investigators to suggesting revisions, 50 percent of the schools said they would allow it, while 40 percent would not. Twenty-four percent of schools would allow industry sponsors to insert their own statistical analyses into manuscripts, 47 percent would not, and 29 percent were not sure. Some 41 percent of schools would allow sponsors to bar investigators from sharing data with third parties after the trial was over--a practice some scientists view as important for verifying research findings.
Lead author Michelle Mello wrote, "We found a few areas of consensus and many differences among the institutions in what they viewed as acceptable or unacceptable provisions in agreements with industry sponsors of clinical research. The variation raises the possibility that industry sponsors could 'forum shop,' channeling their studies to relatively permissive institutions."
The level of control that industry sponsors exercise over clinical research has been the subject of considerable concern in recent months following allegations that pharmaceutical companies did not disclose study results about the safety risks of Vioxx and other COX-2 inhibitors in a timely fashion. Pharmaceutical companies contract with both academic medical centers and commercial research organizations to conduct clinical trials.
Mello commented, "Partnerships between industry sponsors and academia are absolutely essential to the advancement of medical science, and the public benefits incalculably from them. But these relationships have to be carefully managed to avoid problems. Further dialogue about how to structure them would be helpful in balancing sponsors' needs against investigators' academic freedom and the public's interest."
The research was funded by the National Institute of Neurological Disorders and Stroke and the Department of Health and Human Services' Office of Research Integrity.
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New England Journal of Medicine