Last Updated: 2002-10-23 17:00:43 -0400 (Reuters Health)

By Amy Norton

NEW YORK (Reuters Health) - Contracts between US medical schools and the industry sponsors of their clinical trials "routinely" fall short of guidelines intended to protect the integrity of medical research, according to a report out Wednesday.

A national survey of 108 medical schools found that the institutions frequently engaged in industry-sponsored research that failed to meet revised guidelines set up last year by the International Committee of Medical Journal Editors (ICMJE). The revisions, made in response to recent concerns about private industry's hand in academic medical research, are aimed at protecting researchers' independence from their financial sponsors.

The ICMJE guidelines for research papers submitted to biomedical journals call for full disclosure of the trial sponsor's role in the research, along with assurances that the investigators are independent of the sponsor, were in charge of the trial design and conduct, had access to all trial data, and controlled all editorial and publication decisions.

But based on the new survey, the contracts between medical schools and industry sponsors are often "silent" on these issues, the study's lead author, Dr. Kevin A. Schulman, told Reuters Health.

He and his colleagues found that these agreements "rarely" required an independent executive committee or a data and safety monitoring board, and "infrequently" mentioned how trial data would be collected and monitored or interpreted. Contracts also "rarely" required that the study results, good or bad, be published--or that an independent committee make the publication decision.

This is a key concern because negative study results provide invaluable data on a treatment's usefulness, noted Schulman, a researcher at Duke University in Durham, North Carolina.

"Negative information is critical," he said.

Schulman also pointed out that many patients participate in clinical trials not only to get a potential new treatment, but also to help other people by advancing research. If negative study results are kept quiet, then the institutions and sponsors can be seen as failing to honor their commitment to participants, he said.

"Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed," Schulman and his colleagues report in the October 24th issue of The New England Journal of Medicine (NEJM).

Such a revamping, according to Schulman, could come at the level of individual academic centers or through national guidelines set by the Association of American Medical Colleges.

"This survey paints a bleak picture of the state of academic-industrial contracting," writes NEJM editor Dr. Jeffrey M. Drazen in an accompanying commentary.

He points to the example of a Canadian doctor, Nancy Olivieri, who entered into a research contract with a drug company, then was later sued when she tried to publish findings "that could have been construed as damaging to the company."

Had she had a contract that better protected researchers' independence, Drazen notes, "it is likely that the entire crisis could have been averted."

SOURCE: The New England Journal of Medicine 2002;347:1335-1341, 1362-1363

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