Centre for Health Informatics, Australian Institute of Health Innovation, Faculty of Medicine, Health, and Human Sciences, Macquarie University, Sydney, NSW, Australia..
The University of Sydney, Biomedical Informatics and Digital Health, School of Medical Sciences, Faculty of Medicine and Health, Sydney, NSW, Australia..
Contemp Clin Trials. 2022 Jun;117:106785. doi: 10.1016/j.cct.2022.106785. Epub 2022 May 5.
We aimed to investigate the trial characteristics associated with earlier results reporting on ClinicalTrials.gov.
We sampled interventional trials registered with ClinicalTrials.gov and examined the time from trial completion to results reporting on ClinicalTrials.gov as the event of interest. A Cox proportional hazards model was used to examine associations between the time to results reporting on ClinicalTrials.gov with funding type, intervention type, number of enrolled participants, trial phase, trial allocation status, and the year of trial completion. The model accounts for multiple risk factors simultaneously.
Among 102,404 completed trials, the median follow-up for the result reporting event was 18.5 months (IQR 12.7-33.6), during which time 25% (26,608 of 102,404) had results available on ClinicalTrials.gov. Compared to industry funded trials (18.1 months), non-industry trials (median 18.8 months) had results reported slower (HR 0.35, 95% CI 0.34-0.36); compared to drug trials (18.4 months) non-drug trials (19.0 months) were reported slower (HR 0.61, 95% CI 0.59-0.64); compared to trials with more than 50 participants (18.0 months), smaller trials (19.3 months) were reported slower (HR 0.97, 95% CI 0.94-0.99).
Non-industry, non-drug, and earlier phase trials reported results on ClinicalTrials.gov more slowly if at all. Much of the efforts aimed at improving trial reporting through structured reporting on ClinicalTrials.gov have been focused on industry funded drug trials, but these results suggest that incentives and tools targeting non-industry and non-drug trials are also needed.
我们旨在研究与 ClinicalTrials.gov 更早报告结果相关的试验特征。
我们抽取了在 ClinicalTrials.gov 注册的干预性试验，并将从试验完成到在 ClinicalTrials.gov 报告结果的时间作为感兴趣的事件进行了研究。我们使用 Cox 比例风险模型来检验 ClinicalTrials.gov 报告结果的时间与资金类型、干预类型、入组参与者数量、试验阶段、试验分配状态和试验完成年份之间的关联。该模型同时考虑了多个风险因素。
在 102404 项已完成的试验中，结果报告事件的中位随访时间为 18.5 个月（IQR 12.7-33.6），在此期间，有 25%（26608 项）在 ClinicalTrials.gov 上可获得结果。与工业界资助的试验（18.1 个月）相比，非工业界资助的试验（中位数 18.8 个月）报告结果的速度较慢（HR 0.35，95%CI 0.34-0.36）；与药物试验（18.4 个月）相比，非药物试验（19.0 个月）报告结果的速度较慢（HR 0.61，95%CI 0.59-0.64）；与参与者超过 50 人的试验（18.0 个月）相比，参与者较少的试验（19.3 个月）报告结果的速度较慢（HR 0.97，95%CI 0.94-0.99）。
非工业界、非药物和早期阶段的试验，如果有报告结果的话，报告速度会更慢。通过在 ClinicalTrials.gov 上进行结构化报告来提高试验报告质量的努力主要集中在工业界资助的药物试验上，但这些结果表明，也需要针对非工业界和非药物试验制定激励措施和工具。
