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登记的玻璃眼试验的出版率和模式

Leo L T Meller¹, Michael Saheb Kashaf¹, Angel Sambo¹

¹Hamilton Glaucoma Research Center, Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California.

|April 11, 2025

概括

已注册的玻璃眼试验的公布率很低,只有53%的研究结果被公布,而大量的延迟阻碍了对关键研究结果的及时传播.

科学领域:

眼科和临床研究.
生物医学数据科学生物医学数据科学
基于证据的医学基于证据的医学.

背景情况:

青光眼的研究依赖于及时公布注册临床试验以获得基于证据的实践.
理解出版模式对于评估科学文献的完整性至关重要.
美国食品和药物管理局 (FDA) 要求对试验结果进行报告期.

研究的目的:

分析在clinicaltrials.gov.gov上注册的青光眼临床试验的发表率和模式.
为了确定与公布青光眼试验结果相关的因素.
评估是否遵守强制性报告时间表和发布延迟.

主要方法:

来自ClinicalTrials.gov (查询时间为2024年8月) 的所有注册的玻璃眼试验的横截面分析.
提取的研究特征和从研究开始到初级完成的时间.
使用PubMed.gov,ClinicalTrials.gov和Google Scholar.gov验证了出版状况

主要成果:

在969项注册的玻璃眼试验中,53%被公布,只有23%符合FDA的12-24个月报告期.
从研究完成到出版,观察到大约34个月的显著出版延迟.
非美国和非行业赞助的试验显示出更高的出版可能性;干预性试验更有可能被公布,而不是观察性试验.

结论:

只有不到一半的注册的玻璃眼试验被公布,对FDA报告时间表的遵守很差.
在试验完成和发表之间存在相当大的延迟,这可能表明信息传播偏差.
需要进一步调查及时发表青光眼试验的障碍和促进因素.

关键词:

在临床试验.gov.青光眼临床试验青光眼临床试验出版偏见出版偏见的偏见

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