Do subjects want to know about conflicts of interest? Not necessarily
This is my site Written by Alex on August 28, 2009 – 11:08 am   

An article in Scientific American states that “patients” in clinical trials would prefer to be informed if researchers in their clinical trial have a financial conflict of interest in the outcome of the research. The premise, however, that subjects are eager for such disclosure, is not necssarily true and might actually be false.

A 2003 survey, led by Scott Kim, an associate professor in the bioethics program at the University of Michigan at Ann Arbor, showed that if participants were told that a researcher or institution testing a treatment was being funded by the pharmaceutical company that made the drug, 40 percent would be more willing to participate—a finding Kim chalks up to an appreciation for up-front honesty,” says the the article, Should Doctors Disclose Conflicts of Interest to Trials Patients? “If the financial arrangement were switched, however, and a researcher had an equity investment in a company that owned the treatment method (and their share of earnings would increase if a treatment went to market and did well), more than a third of patients said they would be less willing to participate.”

The research sited in the article was conducted in 2003. But citing research conducted in 2006 in  Chasing Medical Miracles and published in the New England Journal of Medicine in an article by Lindsay A. Hampson, Manish Agrawal, Steven Joffe, Cary P. Gross, Joel Verter, and Ezekiel J. Emanuel, titled “Patients Views on Financial Conflicts of Interest in Cancer Research Trials,” I wrote:

“In a study to find out what subjects enrolled in clinical trials for cancer treatments thought about conflicts of interest, such as researchers or hospitals paid by the same sponsors of clinical trials being conducted by the hospital or researcher, 90 percent say they’re not worried about it. In almost every conceivable additional scenario presenting a financial conflict of interest between drug companies and researchers the majority of cancer sufferers were not bothered by the conflict: 77 percent of patients said they still would have enrolled in the trial if their cancer treatment center owned stock in the company sponsoring the trial; 81 percent thought it was ethical for researchers to be paid speaking fees by the sponsors of the clinical trials they were working on; 70 percent would have enrolled even if they knew beforehand that the researchers conducting the trial owned stock in the company sponsoring the trial. Fewer than half the subjects wanted to be told about what kind of oversight was in place for conflict of interest and wanted disclosure of any financial ties between researchers and the companies sponsoring trials.”

This may be viewed by some as a case of lies, damned lies, and statistics, but the clearest indication about whether subjects are demanding disclosure is best summed up in the lack of outcry for such disclosure by subjects, medical groups, and doctor’s groups. It is not illegal to refuse to disclose such conflicts. Disclosure of conflicts of interest is not even a line on a consent form. Someone should consider studying enrollment rates comparing a study with a consent form that contains a disclosure provision and one that does not. The results might be surprising.

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