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行业资金对生物疗法随机对照试验的影响。

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

作者信息

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

机构信息

Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON L8S 4L8, Canada.

Division of Orthopaedic Surgery, Department of Surgery, University of Toronto, Toronto, ON M5G 1X5, Canada.

出版信息

Medicines (Basel). 2022 Feb 28;9(3):18. doi: 10.3390/medicines9030018.

Abstract

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. 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. 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%, = 5.867, = 0.015) and were significantly more likely to utilize placebo or no comparator than non-industry-funded trials (78% vs. 49%, = 4.430, = 0.035). 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.

摘要

制药行业对研究和开发新型生物制剂有着浓厚的兴趣。生物制剂领域之外的先前研究表明,行业资金有潜力影响临床试验的设计和结果。本研究的目的是评估行业资金对调查生物疗法疗效的随机对照试验(RCT)的影响。对2018年1月至2020年12月顶级影响因子医学期刊中所有涉及生物疗法的RCT进行了综述。分析了行业资金与具有统计学显著意义的主要结局的存在以及活性对照剂的使用之间的关系。在纳入的157项RCT中,120项(76%)由行业资助,37项(24%)声明无行业资助。与无行业资助的研究相比,行业资助的研究更有可能报告具有统计学显著意义的阳性主要结局(85%对67%,χ² = 5.867,P = 0.015),并且与非行业资助的试验相比,更有可能使用安慰剂或无对照剂(78%对49%,χ² = 4.430,P = 0.035)。与高影响因子医学期刊中无行业资助的生物疗法试验相比,行业资助的生物疗法试验更有可能产生具有统计学显著意义的阳性结局并使用安慰剂对照。

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