Disclosure of funding sources affects physician evaluation of research studies
EthicsA large proportion of clinical trials of new treatments is funded by the pharmaceutical industry. There is growing concern over how such support can affect the design of these trials and the reporting of the results. While some practitioners may be swayed by potential bias in industry-supported publications to use certain medications more widely than would be appropriate, a new study found that physicians were about half as willing to prescribe new drugs if the clinical trial were performed with industry funding compared to funding from the National Institutes of Health (NIH). Researchers presented a randomly selected national sample of 503 board-certified internists with hypothetical scenarios in which three new drugs were being evaluated for the treatment of unmet clinical needs commonly encountered in primary care. For each drug, one trial had a high level of methodologic rigor, one had a medium level of rigor, and one had a low level of rigor. The scenarios also allowed for three variations on funding status: no funding source mentioned, funding by the NIH, or funding by one of a dozen different pharmaceutical companies.
In general, internists were about four times as likely to prescribe drugs tested in high-rigor trials, compared to medium-rigor trials and eight times as likely compared to low-rigor trials. However, keeping the methodologic rigor constant, physicians were about one-third less willing to prescribe drugs tested in studies funded by a pharmaceutical company compared to studies with no funding support listed, and about half as willing compared to studies listed as supported by NIH. The researchers attributed these results to recent high-profile reports of unethical trial conduct by pharmaceutical companies, including selective reporting of data. They concluded that disclosure of the funding source can have important effects on physicians’ perceptions of the research. Yet these effects were indiscriminate, similarly affecting high-quality and low-quality studies. Therefore, more fundamental strategies, such as ensuring protocol and data transparency and providing an independent review of end points, will be needed to more effectively promote the translation of high-quality clinical trials—whatever their funding source—into practice. This study was supported in part by AHRQ (HS18465).
See "A randomized study of how physicians interpret research funding disclosures," by Aaron S. Kesselheim, M.D., J.D., Christopher T. Robertson, Ph.D., J.D., Jessica A. Myers, Ph.D., and others in the September 12, 2012 New England Journal of Medicine 367(12), pp. 1119-1126.
Current as of April 2013Internet Citation: Disclosure of funding sources affects physician evaluation of research studies: Ethics. April 2013. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/news/newsletters/research-activities/13apr/0413RA16.html