Industry Sponsorship and Research Outcomes in A Sample of Landmark Ophthalmology Trials.

Abstract

To evaluate ophthalmology trials, with versus without industry sponsorship, on the reporting of outcomes, conclusions, and risk of bias, to evaluate whether they favour the investigational product. Retrospective cohort study. We identified a sample of landmark ophthalmology trials (with any publication year) defined as those indexed by 1 of several publicly available sources, including EyeWiki, 1 textbook, the National Institutes of Health, and ophthalmologist-led online sources. A sponsor-favoured intervention was defined as: a) the active treatment in placebo-controlled studies, b) the product produced by the sponsor in head-to-head studies, or c) if both interventions were produced by the sponsor, the intervention with the more recent US Food and Drug Administration approval or recency in clinical trial development. Primary trial results were considered favorable for the industry sponsor if the sponsor-favoured intervention was efficacious, had reduced harms surveillance, or was non-inferior compared to the control arm. The main outcomes were reporting of favourable results, favourable study conclusions, and risk of bias (RoB2 tool). Relative risk (RR) with 95% CIs were calculated to compare the incidence of these outcomes between funding groups. We identified 114 trials, including 50 (43.9%) trials that received industry funding and 64 (56.1%) trials without industry funding. Industry sponsored trials were significantly associated with more frequent reporting of results (RR=1.50 [95% CI: 1.11-2.03], P = .03) and conclusions (RR = 1.64 [95% CI: 1.23-2.17], P = .01) that were favourable to investigational products. Industry-sponsorship was significantly associated with missing outcomes based on RoB2 evaluation (β = 2.33, P = .03), whereas no difference was noted for other domains and the total RoB2 rating. Among pivotal ophthalmology trials, industry sponsorship was associated with results and conclusions that favoured investigational products compared to non-industry sponsored trials. This disparity was not comprehensively explained by the commonly used RoB2 tool, since both groups did not significantly differ over most domains. Our results support need for transparent research practices and continued critical appraisal of the existing trial literature.