Yilmaz Taygan, Gallagher Michéal J, Cordero-Coma Miguel, Gealy Daniel, Loporchio Salvatore, Padula William V, Loporchio Dean, Statler Brittney, Migliori Michael
Division of Ophthalmology, Warren Alpert Medical School at Brown University, Providence, RI.
Department of Ophthalmology, Hermitage Medical Clinic, Dublin, Ireland.
Can J Ophthalmol. 2020 Feb;55(1):71-75. doi: 10.1016/j.jcjo.2019.06.007. Epub 2019 Aug 13.
Discontinuation of interventional clinical trials and nonpublication of completed trials represent a waste of already scarce resources. We sought to identify the prevalence of discontinuation and nonpublication of interventional clinical trials conducted in ophthalmology patients.
A retrospective, cross-sectional study of ophthalmology-based interventional clinical trials in ClinicalTrials.gov dating back to 1972 was conducted. χ tests were used to determine any potential associations between trial characteristics and trial completion. The Mann-Whitney U test was used to compare median time to publication between academic and industry-sponsored trials.
Of 2926 included trials, 413 (14%) were discontinued early with only 19 of these studies being published. A total of 2027 (81%) of the 2513 completed trials were not published. A total of 277 419 participants were enrolled in unpublished, completed trials, whereas an estimated 20 843 participants were enrolled in trials that were never completed and never to led to publication. The odds of study discontinuation among industry-sponsored trials were 27% greater than government/academia-sponsored (National Institutes of Health, National Eye Institute, National Institutes of Health Clinical Center, U.S. and foreign university-based teaching hospitals) trials (odds ratio [OR] = 1.27, 95% confidence interval [CI] 1.03-1.57, p = 0.03). Furthermore, the odds of nonpublication among industry-sponsored trials were 55% more than those funded by government/academia (OR = 1.55, 95% CI 1.27-1.89, p < 0.0001).
The nonpublication of many completed trials and of preliminary results of trials that are discontinued early dilutes the quality and decreases the comprehensive nature of the medical literature. This occurs in both industry and academia. Greater transparency through the publication of the entire spectrum of clinical trials' results as well as those that are terminated early could minimize publication bias and thus lead to a more robust medical literature.
终止介入性临床试验以及不发表已完成的试验结果，意味着对本就稀缺的资源造成浪费。我们试图确定在眼科患者中进行的介入性临床试验的终止率和未发表率。
对ClinicalTrials.gov网站上可追溯至1972年的以眼科为基础的介入性临床试验进行了一项回顾性横断面研究。采用χ检验来确定试验特征与试验完成之间的任何潜在关联。使用Mann-Whitney U检验来比较学术赞助试验和行业赞助试验之间的中位发表时间。
在纳入的2926项试验中，413项（14%）提前终止，其中只有19项研究发表。在2513项已完成的试验中，共有2027项（81%）未发表。共有277419名参与者参加了未发表的已完成试验，而估计有20843名参与者参加了从未完成且从未发表的试验。行业赞助试验的研究终止几率比政府/学术界赞助（美国国立卫生研究院、国立眼科研究所、国立卫生研究院临床中心、美国及国外大学附属医院）的试验高27%（优势比[OR]=1.27，95%置信区间[CI]1.03-1.57，p=0.03）。此外，行业赞助试验的未发表几率比政府/学术界资助的试验高55%（OR=1.55，95%CI 1.27-1.89，p<0.0001）。
许多已完成试验以及早期终止试验的初步结果未发表，削弱了医学文献的质量，降低了其全面性。这种情况在行业和学术界都存在。通过发表所有临床试验结果以及早期终止试验的结果来提高透明度，可以最大限度地减少发表偏倚，从而产生更可靠的医学文献。
