Boston, MA — All major clinical trials now include disclosures detailing who funded the study to ensure transparency. However, is it possible that this transparency is actually hurting research? One might assume that the methodological rigor of the study matters to physicians more than the disclosure. However, in a new study, researchers at Brigham and Women's Hospital (BWH) have found that pharmaceutical industry sponsorship of a research study negatively influences physicians' perceptions of the study and their willingness to believe and act on the research findings. This study will be published in the September 20, 2012 issue of the New England Journal of Medicine (NEJM).
"We found that physicians downgraded their perceptions of industry funded research similarly for high-quality studies and low-quality studies," explained Aaron Kesselheim, MD, JD, assistant professor of medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics at BWH, and principal investigator of this study.
The research team presented abstracts describing hypothetical clinical trials of three fictional, but potentially useful, new drugs to a national sample of board-certified internal medicine physicians. Each abstract was randomized to demonstrate high, medium, or low methodological rigor and randomized to report one of three disclosure variables: funding from a pharmaceutical company, funding by the National Institutes of Health (NIH), or no disclosure listed. The investigators then assessed physicians' impressions of the trials' rigor, their confidence in the results, and their willingness to prescribe the drugs.
"We found clear associations between the funding disclosure variations and physicians' perceptions of a trial's rigor and results," explained Dr. Kesselheim.
The results showed that physicians downgraded the credibility of industry-funded trials when compared with the same trials that had no funding listed, and to an even greater extent when compared with the same trials characterized as having NIH funding. The authors attributed these results to high-profile instances of unethical behavior by pharmaceutical companies sponsoring clinical research in the past decade.
Researchers emphasize that these findings have important implications. The pharmaceutical industry funds a substantial portion of clinical research, and a key determinant of the impact of a trial should be its methodological rigor, not its funding source, Dr. Kesselheim and his co-authors argue.
"While there is good reason to be extra vigilant about industry-funded research, if physicians are reluctant to trust all such research, this could hinder the translation of even high-quality industry-funded research into practice. Strategies such as greater transparency and independent review of trial data could be pursued to try to change such attitudes among physicians," Dr. Kesselheim suggested.
This research was supported by a grant from the Edmond J. Safra Center for Ethics at Harvard University, a career development award from the Agency for Healthcare Research and Quality (K08HS18465-01) and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research (both to Dr. Kesselheim), a fellowship at the Petrie–Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School (to Dr. Robertson), and a grant from the National Cancer Institute (2R25CA092203-08, to Dr. Rose).
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving nearly 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $625 million in funding. BWH continually pushes the boundaries of medicine, including building on its legacy in organ transplantation by performing the first face transplants in the U.S. in 2011. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies, OurGenes and the Women's Health Initiative. For more information and resources, please visit BWH's online newsroom.
Journal
New England Journal of Medicine