Study: Industry-sponsored clinical trials rarely follow guidelines

Wednesday, October 23rd 2002, 12:00 am

By: News On 6

The drug companies that pay for major testing of most new medicines give the participating university researchers little or no say in how the studies are designed and how the findings are handled, a survey found.

The survey of 108 medical schools, published in Thursday's New England Journal of Medicine, is the latest sign of growing concern about conflicts of interest between those doing scientific research and the pharmaceutical companies sponsoring it.

``What the institutions have told us is they feel almost powerless in these contracts,'' said Dr. Kevin Schulman, a Duke University Medical Center professor who led the survey.

While federal agencies sponsor much early research, large-scale studies of drugs' safety and effectiveness are usually paid for by the manufacturers. Typically, the companies hire medical school faculty members to carry out the studies.

But some scientists worry their lack of control could threaten the integrity of research and the safety of the volunteers participating. Among other things, pharmaceutical companies have sponsored research that found a drug didn't work or was dangerous, then suppressed the results.

Concerned about the problem, the International Committee of Medical Journal Editors in 2001 published guidelines for research contracts between medical schools and the pharmaceutical industry.

Last winter, researchers at Duke University Medical Center and Duke's law school interviewed officials at U.S. medical schools and reviewed some of their research contracts to determine how many complied with the new guidelines. Only a minority did.

Schulman said researchers have less and less control over patient trials as more and more studies include dozens of medical centers, rather than just one, a strategy meant to bring results faster.

Among the study's findings:

_ Researchers rarely were allowed a say in the design of the clinical trials, with only 10 percent of contracts covering how data is collected and monitored and only 5 percent covering how data is analyzed and interpreted.

_ Less than 1 percent of contracts guaranteed that results would be published and that an independent committee would have control over that. But 40 percent of contracts addressed editorial control of manuscripts.

_ Only 1 percent of contracts required an independent board to monitor patient safety. Such boards can stop a study early if the treatment is found to be harming participants.

``It is very worrying,'' said Mary Ann Baily, associate for ethics and health policy at the Hastings Center, a Garrison, N.Y., think tank. ``The future of research and patient welfare does depend on how we approach this.''

Financial ties between academic researchers and industry sponsors already are under scrutiny for apparent conflicts of interest, as when researchers receive stock in a company testing an experimental drug.

Over the summer, the Pharmaceutical Research and Manufacturers of America established voluntary guidelines for clinical research, but they are ``basically toothless,'' said Dr. Jeffrey M. Drazen, editor of the New England Journal.

``The system would be better served if there were universally accepted contractual language,'' he wrote in an editorial.

PhRMA did not immediately respond to a request for comment on the study.

In another opinion piece, doctors wrote that such protections are critical because future medical research will depend even more closely on partnerships between universities and industry; they suggested creating a national panel to deal with conflict-of-interest issues.

A third opinion piece by doctors and an industry consultant said universities must set firm policies protecting their researchers from financial influences.