What do doctors think about industry-sponsored clinical trials? Harvard’s Dr. Aaron S. Kesselheim wanted to know.
To find out, Dr. Kesselheim – who is also an M.P.H.–wielding attorney – cooked up abstracts for clinical trials of three fictional drugs. The trials had different degrees of rigor (low, medium, or high) and three different types of disclosures (drug-company funding, NIH funding, or no disclosed funding). He passed the abstracts on to a group of about 500 internists and collected the impressions of 269 of them.
Copyright thinkstockphotos.com
Respondents did a good job of recognizing the differences among the low-, medium-, and high-rigor trials, and in fact said they would be 36% less likely to prescribe drugs tested in low-rigor trials compared with medium-rigor trials. However, they also downgraded the rigor of industry-funded trials, and said they were 32% less likely to prescribe drugs from industry-funded trials compared with drugs from trials with no disclosure of funding.
"Physicians’ skepticism of industry-funded research affected their responses to high-rigor and low-rigor trials similarly," Dr. Kesselheim and his colleagues noted.
Further, the internists were half as inclined to prescribe drugs studied in industry-funded trials compared with drugs studied in NIH-funded trials.
This skepticism and underprescribing of drugs tested in industry-funded trials could have a chilling effect on advances in care, according to Dr. Kesselheim. "For example, after publishing the results of a large, well-designed trial describing a new use for a widely prescribed class of drugs, a leading biomedical journal noted that many of its readers believe that the results of the trial did not justify a change in clinical management, citing industry funding as a key reason for this conclusion."
What’s a drug manufacturer to do? Get the feds involved, apparently. The doctors deemed NIH-funded studies to be the most credible, so an increase in the number of NIH-funded trials "might reduce clinicians’ skepticism and lead to more data-driven changes in practice," the researchers said.
On average, the doctors who participated in the study said that they devoted 80% of their time to primary care. Their median age was 48 years, about two-thirds were male, and 56% had attended a U.S. medical school.
Ironically, 76% of the doctors said that they had received industry support.
The study was published Sept. 19 by the New England Journal of Medicine (N. Engl. J. Med. 2012;367:1119-27). In the interest of full disclosure, it was funded in part by an ethics grant from Harvard University, as well as grants to Dr. Kesselheim from the Agency for Healthcare Research and Quality and the Robert Wood Johnson Foundation.
–Heidi Splete (@hsplete on Twitter)