ld 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."

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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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