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How Independent Is Academic-Industry Research?

Study: Contracts often fail to meet guidelines on data integrity

WEDNESDAY, Oct. 23, 2002 (HealthDayNews) -- Universities often sign away the independence of their scientists when their lawyers ink agreements with industry to perform company-funded research.

That's the conclusion of a new study, which found that medical school collaborations with biotech firms rarely meet the standards of journals hoping to safeguard the integrity of the data they publish. Researchers are often deprived of full access to data, aren't allowed to help shape the design of the trials, and aren't given full editorial control over information they want to report.

"We don't have the proper protections in place to insure that all the data are out about every trial that's been conducted," says Dr. Kevin Schulman, a Duke University physician and lead author of the study. The International Committee of Medical Journal Editors (ICMJE) last year issued guidelines designed to avoid conflicts of interest in the studies they publish. "The level of compliance that we found [with the ICMJE recommendations] is very low," Schulman says.

Many researchers may reach parallel agreements with companies that secure more freedom to publish the data they collect. Schulman's group didn't address those contracts. However, their survey found that university lawyers complained of feeling "powerless" to alter the contracts firms offer them, he says. "Sponsors actually almost are in a position to say, 'Take it or leave it,'" he says.

Schulman and his colleagues report their findings in tomorrow's issue of The New England Journal of Medicine, which is among more than 500 publications that adhere to the ICMJE standards.

The researchers surveyed 108 of the nation's academic medical centers between November 2001 and January of this year, asking them 22 questions about their contracts with industry. Each university signed an average of 103 research agreements with companies in the preceding year. The study looked only at trials that are conducted at several centers and not at those where the work was done at just one place.

One percent of school officials who responded said all their contracts let their scientists have access to all the trial data and not just that collected at their facility. Ten percent said all their agreements permitted investigators to help shape the data collection and monitoring plan governing the studies.

The typical contract didn't address who would have editorial control over materials published with the data generated in the trials or the details of authorship of those reports. The vast majority didn't include language about independent steering committees or patient safety and monitoring boards.

Schools that were the leading research site tended to report better levels of compliance with the ICMJE guidelines.

Schulman says it's not clear how much failure to meet the editors' recommendations jeopardizes the integrity of journal articles. However, he cites a recent report in a leading medical journal in which company-funded researchers provided only favorable data from the first six months of a yearlong trial that ultimately proved less promising.

That's just an example of a case where unfavorable data was muzzled, he adds. "We don't know about other information the sponsors have never published" because of the constraints of their contracts, Schulman says.

Schulman says the 2001 ICMJE guidelines should help safeguard the integrity of scientific publications, and he acknowledges the timing of the survey didn't leave school officials much chance to absorb the recommendations. However, he says, academic medical centers should band together to create standard contracts that are more favorable to investigators when dealing with industry-sponsored research.

"No matter how altruistic the motive, investigators must recognize that research performed under these contracts is a business transaction," writes Dr. Jeffrey Drazen, editor in chief of The New England Journal of Medicine, in an editorial accompanying the article. Drazen calls it "imperative" that the contracts guarantee not only the safety and confidentiality of patients but the academic freedom of scientists.

Dr. David Korn, senior vice president at the Association of American Medical Colleges, a Washington, D.C. trade group, said his organization "fully supports" the editorial guidelines. But he called the latest study "a bit misleading" because it focused only on multi-center trials, in which satellite investigators typically don't have access to all the data anyway.

What's more, Korn said, medical schools come in a wide range of sizes. Small schools may find industry money such a key part of their research portfolio that they feel constrained in their contract negotiations with companies. Larger programs with other sources of funding may be more inclined to press harder for better terms.

The journal this week published other articles about scientific independence, including one that called for a national arbitration panel to resolve disputes between companies and researchers.

Drazen calls that idea "reasonable," but adds it would be preferable to adopt standard contracts to avoid such disputes in the first place.

Dr. Frank Davidoff, a former editor of the Annals of Internal Medicine and an architect of the new journal editors' guidelines, says the content of contracts hasn't been given as much attention as it deserves. "Maybe it's time to begin to clean it up," he says.

These sorts of ethical "slippages" aren't as spectacular or as widely publicized as major examples of interest conflicts. "But they probably do influence the way people practice medicine in a way that maybe they shouldn't," Davidoff says.

What To Do

To find out more about the guidelines, visit the ICMJE . For more on clinical trials, try CenterWatch.

SOURCES: Kevin Schulman, M.D., professor, medicine, Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Durham, N.C.; Frank Davidoff, M.D., former editor, Annals of Internal Medicine, Wethersfield, Conn.; David Korn, M.D., senior vice president, Association of American Medical Colleges, Division of Biomedical and Health Sciences Research, Washington, D.C.; Oct. 24, 2002 New England Journal of Medicine

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