Survey of academic medical centers' standards for clinical-trial agreements with

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Survey of academic medical centers' standards for clinical-trial

agreements with industry, USA

26 May 2005 Medical News Today

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.

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decide that research results should not be published, and 96 percent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 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 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.