Industry sponsorship and research outcome
Funding for biomedical research worldwide comes from three sources: government agencies, private non-profit organisations, and private industry. Funding of clinical trials by private industry, including pharmaceutical, biotechnology and medical device companies, is an increasing source of clinical research sponsorship, accounting for nearly 60% of research funding in the US in 2007, compared with 33% contributed by the US federal government.
Earlier research investigating sources of funding for clinical research has found that pharmaceutical industry-sponsored studies tend to favor sponsors’ drugs more than studies with other sources of sponsorship. This suggests the possibility that sponsorship by industry is associated with publication of outcomes that are favorable to the sponsor. An earlier systematic review which focused on examining industry sponsorship of research studies was limited to studies involving drugs. For this update, the research team decided to expand the evidence base to medical devices.
The Cochrane Review, published in December 2012, provides a synthesis of 48 papers which had addressed this question by comparing primary research studies of drugs or medical devices sponsored by industry with studies with other sources of sponsorship. Each of these papers had examined a number of primary studies (median 137 per paper, with a range of 9-930) to look for evidence of sponsorship bias. Some of the included papers focused on studies related to specific drug classes, to specific medical specialties or diseases, or to a specific type of device.
The Cochrane authors’ findings support those indicated by earlier research: studies sponsored by industry reported greater benefits and fewer harmful side effects compared to studies that were not sponsored by industry. Papers describing industry-sponsored studies presented more favourable overall conclusions, and results and conclusions sections in these papers were less likely to agree.
“Our results suggest that industry-sponsored drug and medical device studies are more often favourable to the sponsor’s products than non-industry-sponsored studies,” said lead researcher Andreas Lundh of the Nordic Cochrane Centre, Rigshospitalet in Copenhagen, Denmark. “These findings resonate with current calls for better access to information about how trials are carried out, and raw data.”
The research team also reports that their analyses “suggest the existence of an industry bias that cannot be explained by standard 'Risk of bias' assessments” and makes recommendations on the development of methods to report, assess and handle industry bias. The research team’s conclusions include the suggestion that guidelines and reviews, including Cochrane Reviews, could improve transparency by disclosing sponsorship when results from industry-sponsored studies are reported, and by regarding industry sponsorship as a factor that increases the risk of bias.
“Industry sponsorship should be reported in original published studies, but it must also be taken into account when results are reported on elsewhere,” said senior author Lisa Bero of the Department of Clinical Pharmacy and Institute for Health Policy Studies at the University of California San Francisco in San Francisco, US. “If we agree that industry sponsorship is an important source of bias then we need to think about developing better methods for reporting, assessing and handling industry bias in systematic reviews that evaluate the effects of drugs and devices.”