The Impact of Industry Funding on Randomized Controlled Trials of Biologic Therapies

Abstract

Background: There has been substantial interest from the pharmaceutical industry to study and develop new biologic agents. Previous studies outside of the biologics field have demonstrated that industry funding has the potential to impact the design and findings of clinical trials. The objective of this study was to evaluate the impact of industry funding on randomized controlled trials (RCTs) that investigated the efficacy of biologic therapies. Methods: A review of all RCTs involving biologic therapies in top impact factor medical journals from January 2018 to December 2020 was performed. The relationship between industry funding and the presence of statistically significant primary outcomes and the use of active comparators were analyzed. Results: Among the 157 RCTs included, 120 (76%) were industry funded and 37 (24%) declared no industry funding. Industry-funded studies were significantly more likely to report a statistically significant positive primary outcome compared to studies without industry funding (85% vs. 67%, χ2 = 5.867, p = 0.015) and were significantly more likely to utilize placebo or no comparator than non-industry-funded trials (78% vs. 49%, χ2 = 4.430, p = 0.035). Conclusions: Industry-funded trials investigating biologic therapies are more likely to yield statistically significant positive outcomes and use placebo comparators when compared to non-industry-funded biologic therapy trials in high-impact medical journals.

Keywords

• biologics
• immunotherapy
• monoclonal antibodies
• randomized controlled trials
• industry funding
• bias