Meller Leo L T, Kashaf Michael Saheb, Sambo Angel, Cizmic Julian, Chen Jeffrey, Moghimi Sasan, Weinreb Robert N
Hamilton Glaucoma Research Center, Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California.
Hamilton Glaucoma Research Center, Viterbi Family Department of Ophthalmology and Shiley Eye Institute, University of California San Diego, La Jolla, California.
Ophthalmology. 2025 Apr 10. doi: 10.1016/j.ophtha.2025.04.007.
To examine the publication rates and patterns of registered glaucoma trials.
Cross-sectional analysis.
All registered glaucoma trials from ClinicalTrials.gov.
The National Institutes of Health ClinicalTrials.gov was queried in August 2024 for all registered glaucoma trials. Study characteristics and time from study start date to primary completion date were extracted, and verification of publication in peer-reviewed journals was confirmed using PubMed.gov, ClinicalTrials.gov, and Google Scholar.
Publication status and characteristics associated with publication.
A total of 969 trials were identified, of which 510 (53%) were published, 222 (23%) were published within the mandated reporting period of 12 to 24 months by the Food and Drug Administration (FDA), and 312 (32%) had results available on ClinicalTrials.gov. Of the evaluated trials, 575 (59%) were nonsurgical (did not focus on surgical procedures), 748 were interventional (77%), 518 were international (54%), and 512 were industry sponsored (53%). The average time from study start date to primary completion date was 24 months, with a delay of primary completion date to publication date of another 34 months. In the overall cohort, non-US-based compared with US-based studies and nonindustry compared with industry sponsorships were more likely to be published (P < 0.05 for both). Industry-sponsored trials were more likely to be interventional (investigator assigned participants to an intervention or no intervention) than observational (participants may receive interventions as part of a study group but not specifically assigned by investigators) (88% vs. 65%, P < 0.01), to be medical rather than surgical (71% vs. 46%, P < 0.01), to be based in the United States (58% vs. 34%, P < 0.01), to have results available on ClinicalTrials.gov (45% vs. 18%, P < 0.01), and to be completed sooner (22 vs. 32 months, P < 0.01). For both industry- and nonindustry-sponsored trials, interventional trials were more likely to be published compared with observational trials (P = 0.04, P = 0.02, respectively).
Only about half of all registered glaucoma trials from ClinicalTrials.gov were published, with less than 25% complying with the mandated FDA report period of 1 to 2 years and overall, a significant delay of nearly 3 years from study primary completion date to publication date. This suggests potential bias in information dissemination of glaucoma trials.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
研究已注册青光眼试验的发表率及模式。
横断面分析。
来自ClinicalTrials.gov的所有已注册青光眼试验。
2024年8月查询美国国立卫生研究院ClinicalTrials.gov上所有已注册的青光眼试验。提取研究特征以及从研究开始日期到主要完成日期的时间，并使用PubMed.gov、ClinicalTrials.gov和谷歌学术搜索确认在同行评审期刊上的发表情况。
发表状态及与发表相关的特征。
共识别出969项试验，其中510项（53%）已发表，222项（23%）在食品药品监督管理局（FDA）规定的12至24个月报告期内发表，312项（32%）在ClinicalTrials.gov上有结果。在评估的试验中，575项（59%）为非手术试验（未聚焦于手术操作），748项为干预性试验（77%），518项为国际试验（54%），512项由行业赞助（53%）。从研究开始日期到主要完成日期的平均时间为24个月，从主要完成日期到发表日期又延迟了34个月。在整个队列中，与美国的研究相比，非美国的研究以及与行业赞助相比，非行业赞助的试验更有可能发表（两者P均<0.05）。行业赞助的试验比观察性试验更有可能是干预性试验（研究者将参与者分配到干预组或非干预组）（88%对65%，P<0.01），更有可能是医学试验而非手术试验（71%对46%，P<0.01），更有可能设在美国（58%对34%，P<0.01），在ClinicalTrials.gov上有结果（45%对18%，P<0.01），且完成得更快（22个月对32个月，P<0.01）。对于行业赞助和非行业赞助的试验，干预性试验比观察性试验更有可能发表（分别为P = 0.04，P = 0.02）。
ClinicalTrials.gov上所有已注册青光眼试验中只有约一半发表，不到25%符合FDA规定的1至2年报告期，总体而言，从研究主要完成日期到发表日期有近3年的显著延迟。这表明青光眼试验信息传播可能存在偏差。
在参考文献之后可能会有专利或商业披露。
