How Much Influence Do Clinical Trial Sponsors Have?

Industry sponsors who funded trials that published results in top-tier journals often played a role in trials’ design and analysis, but those relationships were not always fully disclosed, according to research published in BMJ.

The study included 200 phase III and phase IV trials evaluating vaccines, drugs, and devices for which results were published between 2014 to 2017. Nearly all (92%) of trials reported funders’ involvement in the design of trials, while 73 percent were involved in data analysis and 87 percent were involved in trial reporting. Most industry personnel, contract research organizations, and academic investigators were jointly responsible for trial management and publication, but this involvement was not always reflected in the published declarations of authorship.

In addition to analyzing the studies themselves, researchers also sent surveys to the listed article authors of publications in The New England Journal of Medicine, The Lancet, JAMA, BMJ, Annals of Internal Medicine, and JAMA Internal Medicine. Seventy-three academic teams completed the surveys, which revealed that funders or contractors often contributed to the studies without attribution. Funders, contractors, and regulatory agencies also often had undisclosed roles in trial design and data analysis.

The researchers noted that only 4 percent of industry-funded trials were truly independent of industry involvement, though the study’s authors cautioned that their findings might not be generalizable to trials published in smaller journals.

“Our clinical recommendations depend on clinical trials being reliable and conducted in the patients’ best interests, without commercial considerations,” the study authors wrote. “Independent trials are the way forward; the academic community should refuse collaboration where industry demands control over trial design, conduct, data, statistical analysis, or reporting.”

Despite some startling results, the study also showed that funders never had final say on publication. Further, most academic authors said that their studies benefited from industry involvement.

Sources: MedPage Today, October 3, 2018; Rasmussen K, Bero L, Redberg R, et al. Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authors. BMJ. 2018;363:k3654.