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工业参与和透明度在最受引用的临床试验,2019-2022年
Leonardo M Siena1,2, Lazaros Papamanolis2, Maximilian J Siebert2
1Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
JAMA network open
|November 14, 2023
概括
行业参与在顶级临床试验中很常见,影响资金,作者和分析,往往导致赞助商有利的结论. 尽管有声明的意图,但数据和代码共享的透明度仍然有限.
科学领域:
- 临床试验研究 临床试验研究
- 医学研究 透明度 医疗研究 透明度
- 工业赞助的研究 工业赞助的研究
背景情况:
- 行业资金显著影响着重要的临床试验.
- 临床试验报告和数据共享的透明度高度可变.
- 了解行业参与的程度和性质对于评估研究完整性至关重要.
研究的目的:
- 评估行业参与高度引用的临床试验的方式.
- 评估这些有影响力的试验的透明度特征,包括数据和协议的可用性.
- 确定行业参与与试验结果之间的关联.
主要方法:
- 600个高度引用的临床试验 (2019年或以后出版) 的横截面元研究研究.
- 分析包括所有医学领域的随机和非随机试验.
- 衡量的主要结果是行业融资,作者权,分析师角色和透明度要素 (协议,SAP,数据/代码可用性).
主要成果:
- 68.2%的试验获得了行业资助,而50.5%的试验仅由行业资助.
- 行业作者 (59.0%) 和分析师 (46.6%) 是很常见的;20.8%的人只使用行业分析师.
- 行业资助的试验经常有利于赞助商 (89.0%),独家资助和行业作者与有利的结论 (ORs ≈ 2.9) 有关.
- 虽然协议 (82.0%) 和统计分析计划 (74.3%) 经常可用,但易于获取的原始数据 (2.7%) 和分析代码 (4.5%) 很少.
- 与非随机试验相比,随机试验更有可能拥有行业分析师和可用的协议/SAP.
结论:
- 行业参与有影响力的临床试验的范围不仅仅是资金,还包括作者和分析,往往与赞助商有利的结果相关联.
- 尽管有意分享,但实际上原始数据和分析代码的可用性非常低.
- 调查结果强调,需要加强对受行业影响的临床研究的透明度和独立监督.
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