Suppr超能文献

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。

相似文献

1
The Impact of Industry Funding on Randomized Controlled Trials of Biologic Therapies.
Medicines (Basel). 2022 Feb 28;9(3):18. doi: 10.3390/medicines9030018.
2
The Quality of Randomized Controlled Trials in High-impact Rheumatology Journals, 1998-2018.
J Rheumatol. 2020 Sep 1;47(9):1446-1449. doi: 10.3899/jrheum.191306. Epub 2020 Apr 1.
4
Industry Funding of Oncology Randomised Controlled Trials: Implications for Design, Results and Interpretation.
Clin Oncol (R Coll Radiol). 2022 Jan;34(1):28-35. doi: 10.1016/j.clon.2021.08.003. Epub 2021 Aug 31.
5
Industry-funded versus non-profit-funded critical care research: a meta-epidemiological overview.
Intensive Care Med. 2018 Oct;44(10):1613-1627. doi: 10.1007/s00134-018-5325-3. Epub 2018 Aug 27.
7
Failure to disclose industry funding impacts outcomes in randomized controlled trials of platelet-rich plasma.
Knee Surg Sports Traumatol Arthrosc. 2023 Feb;31(2):626-631. doi: 10.1007/s00167-022-07118-9. Epub 2022 Aug 20.
8

引用本文的文献

2
Wound management, healing, and early prosthetic rehabilitation: Part 2 - A scoping review of physical biomarkers.
Can Prosthet Orthot J. 2024 Dec 5;7(2):43716. doi: 10.33137/cpoj.v7i2.43716. eCollection 2024.
3
Wound management, healing, and early prosthetic rehabilitation: Part 1 - A scoping review of healing and non-healing definitions.
Can Prosthet Orthot J. 2024 Nov 15;7(2):43715. doi: 10.33137/cpoj.v7i2.43715. eCollection 2024.
4
A single-center real-world review of 10 kHz high-frequency spinal cord stimulation outcomes for treatment of chronic pain.
Interv Pain Med. 2024 Mar 11;3(1):100402. doi: 10.1016/j.inpm.2024.100402. eCollection 2024 Mar.
6
Completeness of intervention description in invasive cardiology trials: an observational study of registry and corresponding publications.
Front Med (Lausanne). 2023 Oct 10;10:1276847. doi: 10.3389/fmed.2023.1276847. eCollection 2023.
7
Disclosing Conflicts of Interest to Potential Research Participants: Good for Nothing?
Ethics Hum Res. 2023 Mar;45(2):2-13. doi: 10.1002/eahr.500157.
8
Systematic review of sample size calculations and reporting in randomized controlled trials in ophthalmology over a 20-year period.
Int Ophthalmol. 2023 Aug;43(8):2999-3010. doi: 10.1007/s10792-023-02687-1. Epub 2023 Mar 14.

本文引用的文献

2
Cost-effectiveness and comparative effectiveness of biologic therapy for asthma: To biologic or not to biologic?
Ann Allergy Asthma Immunol. 2019 Apr;122(4):367-372. doi: 10.1016/j.anai.2019.01.018. Epub 2019 Jan 28.
3
New 2016 Data and Statistics for Global Pharmaceutical Products and Projections through 2017.
ACS Chem Neurosci. 2017 Aug 16;8(8):1635-1636. doi: 10.1021/acschemneuro.7b00253.
4
Industry sponsorship and research outcome.
Cochrane Database Syst Rev. 2017 Feb 16;2(2):MR000033. doi: 10.1002/14651858.MR000033.pub3.
5
Rayyan-a web and mobile app for systematic reviews.
Syst Rev. 2016 Dec 5;5(1):210. doi: 10.1186/s13643-016-0384-4.
6
The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review.
PLoS One. 2015 Mar 17;10(3):e0119683. doi: 10.1371/journal.pone.0119683. eCollection 2015.
8
Biologic agents in rheumatology: unmet issues after 200 trials and $200 billion sales.
Nat Rev Rheumatol. 2013 Nov;9(11):665-73. doi: 10.1038/nrrheum.2013.134. Epub 2013 Sep 3.
9
Treatment success in cancer: industry compared to publicly sponsored randomized controlled trials.
PLoS One. 2013;8(3):e58711. doi: 10.1371/journal.pone.0058711. Epub 2013 Mar 21.
10
Interrater reliability: the kappa statistic.
Biochem Med (Zagreb). 2012;22(3):276-82.

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验