A study of more than 450 clinical trials found that those supported by the pharmaceutical industry were more likely to report stronger evidence, test more innovative and expensive therapies, and were published in open-access journals compared with studies with other funding sources, according to a study published in the Journal of Thoracic Oncology.
“It is conceivable that industry interests may determine the types of research questions to be answered by [randomized clinical trials] and their experimental design,” the authors wrote. Randomized clinical trials (RCTs) require extensive resources to conduct and take time for the final results. As a result, funding is important and many cooperative groups and/or research institutions do not have the resources to conduct trials without an industry sponsor.
“We wanted to determine whether pharmaceutical industry (PI)-funded RCTs would differ significantly from studies funded by other sources,” the authors wrote.
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The study assessed 477 clinical trials published between 2012 and 2017 about non-small cell lung cancer (NSCLC). The trials had to include ≥1 experimental treatment and include only patients with advanced or metastatic NSCLC.
The strength of evidence was higher in trials funded by the PI. PI-funded studies were more likely to have a randomized design compared with trials funded by other sources (55% vs 44%, respectively), whereas PI-funded studies were less likely to have a single-arm (33% vs 62%, respectively) or retrospective case-control (1% vs 5%, respectively) design (P =.031; odds ratio [OR], 1.67; 95% CI, 1.05-2.66).
PI-funded trials were also more likely to test innovative treatment, with 72% of studies compared with 36% of studies funded by other sources (P <.001; OR, 2.81; 95% CI, 1.73-4.56). Trials funded by the PI were also more likely to enroll a higher number of patients and evaluated more expensive therapies.
The results from PI-funded trials were more often published as open-access, in 63% of articles, compared with 47% of articles from trials funded by other sources (P =.004; OR, 1.98; 95% CI, 1.24-3.14). The PI-funded trials were registered with ClinicalTrials.gov 78% of the time compared with 37% of trials funded by other sources. There was no evidence of reporting bias with either funding source.
The proportion of trials that evaluated first- or second-line therapies, biomarker testing, and those which showed a superior outcome with the experimental therapy were similar between PI-funded trials and those funded by other sources.
“We conclude that studies funded by the PI had stronger evidence, tested more innovative therapies, were more accessible to readers, and did not have significantly higher risk of bias or report higher experimental arm superiority than those developed with other sources of funding,” the authors wrote. They also acknowledged that lung cancer trials usually study unequivocal endpoints, which could limit the reporting of inaccurate results.
Reference
de Souza Gutierres B, Aguiar PN, Dourado BB, et al. Evidence strength of pharmaceutical industry- funded clinical trials in metastatic NSCLC: a comparison with other sources of funding. J Thoracic Oncol. 2020;15:1170-1176.
