A recent Scientific American Guest Blog post by Jalees Rehman, MD, explored whether the source of funding affects clinical research quality. Many members of the research community believe that clinical trials sponsored by a commercial entity are potentially biased in favor of the sponsor’s product – a perception that is supported by data from meta-analyses of published trials.
Dr. Rehman highlighted a study published in the New England Journal of Medicine on September 20, 2012, by Dr. Aaron Kesselheim and colleagues at the Harvard Medical School. In this study, 12 physicians were randomly assigned to review and rate abstracts describing hypothetical drug trials. Both the abstracts and the drugs were entirely fictitious. The researchers created 27 different abstracts by varying the name of the study drug, the methodology of the trial and the source of funding. They found that a disclosure of funding from an industry sponsor (as compared to a disclosure of funding from the US National Institutes of Health, or no funding disclosure at all) led to lower ratings, indicating the participating physicians were less confident in the validity of the study results and would be less willing to prescribe the hypothetical drug to their own patients.
As Dr. Rehman points out, this is a positive finding because it suggests that journal readers do pay attention to funding disclosures, and that they can distinguish between trials with high vs. low methodological rigor. The bad news is that it may lead them to discount valid trials. In an editorial accompanying the study, the editors of NEJM suggested this is disrespectful to clinical trial participants. The editors also suggest that federally funded research is not entirely free of bias.
While these are both fair points, the industry could probably stand to work on its image. Full compliance with registration and reporting requirements would be a step in the right direction. So would more realistic press releases, and consistent publication of clinical trial results – negative as well as positive.