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

Aaron M. Gazendam,Nicholas Nucci,Michelle Ghert,Om Bhatt,David Slawaska-Eng

doi:10.3390/medicines9030018

Aaron M. Gazendam, Nicholas Nucci + Show 3 more

Open Access

https://doi.org/10.3390/medicines9030018

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Journal: Medicines	Publication Date: Feb 28, 2022
Citations: 6	License type: CC BY 4.0

Affiliation: McMaster University, University of Toronto

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.

Highlights

Rituximab, an anti-cancer monoclonal antibody, was first approved by the Food andDrug Administration (FDA) for use in the United States in 1997 [1]
We identified 157 randomized controlled trials (RCTs) published between 1 January 2018 and 31 December 2020 that met the inclusion criteria: 93 from New England Journal of Medicine (NEJM), 54 from The Lancet, and 10 from Journal of American Medical Association (JAMA) (Table 1)
We reviewed 157 RCTs that assessed the efficacy of biologic therapies in the three highest impact factor medical journals published in the period of 2018–2020

Summary

Introduction

An anti-cancer monoclonal antibody, was first approved by the Food andDrug Administration (FDA) for use in the United States in 1997 [1]. 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. Industryfunded 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

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