将已完成药品试验的临床试验结果和其他关键信息发布在 ClinicalTrials.gov 上。
Posting of clinical trial results and other critical information from completed medicines trials on ClinicalTrials.gov.
机构信息
Unidad de Bioestadística y Epidemiología, Instituto de Investigación Sanitaria-Hospital Universitario Fundación Jiménez Díaz, Universidad Autónoma de Madrid, Avda. Reyes Católicos 2, E-28040, Madrid, Spain.
Biostatistics and Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain.
出版信息
Eur J Clin Pharmacol. 2023 Oct;79(10):1385-1390. doi: 10.1007/s00228-023-03550-z. Epub 2023 Aug 15.
PURPOSE
Clinical trials transparency requires trial registration and the posting of results on a public register. US regulations also require the posting of protocols and statistical analysis plans (SAPs). For US Federal agency funded trials to be started on or after 21 January 2019, informed consent forms (ICFs) must also be posted. Posting these documents is not mandatory in other countries. We aimed to assess compliance with US regulations of trials conducted in the US or in other countries with respect to ICFs, protocols, SAPs, and results.
METHODS
This cross-sectional analysis (27 April 2023) comprised completed medicines trials to be started on or after 21 January 2019 registered on ClinicalTrials.gov. Trial data were registered by funder type (i.e., 'US federal agencies', industry, and 'all others') and development phase.
RESULTS
Of 5,584 trials, 40% were conducted solely in the US. 47% and 12% of US and non-US trials had posted results. Some 40% of US trials had posted protocols and SAPs as did 9% of trials conducted in other countries. Only 10% (US) and 2% (other countries) of trials had posted ICFs. When the margin of the last 2 and 12 months after primary completion date were considered in the analysis, ICF posting rate did not change, but posting results increased to 64% for US trials. 'US Federal agencies' funded trials were significantly more likely to post ICFs than industry [OR 23.9 (12.5-45.7; <.001)] or 'all others' [OR 3.16 (1.79-5.56; <.001)].
CONCLUSION
Future interventions should be considered to encourage timely posting of trial results and information.
目的
临床试验透明度要求试验注册，并将结果发布在公共注册机构上。美国法规还要求发布方案和统计分析计划（SAP）。对于 2019 年 1 月 21 日或之后开始的由美国联邦机构资助的试验，还必须发布知情同意书（ICF）。在其他国家，发布这些文件并非强制性要求。我们旨在评估在美国或其他国家进行的试验在 ICF、方案、SAP 和结果方面是否符合美国法规。
方法
这是一项横断面分析（2023 年 4 月 27 日），包括将于 2019 年 1 月 21 日或之后开始的已完成的药物试验，这些试验均在 ClinicalTrials.gov 上注册。试验数据按资助者类型（即“美国联邦机构”、行业和“其他所有人”）和开发阶段进行登记。
结果
在 5584 项试验中，40%仅在美国开展。47%和 12%的美国和非美国试验已发布结果。约 40%的美国试验发布了方案和 SAP，同样比例的其他国家试验也发布了 SAP。只有 10%（美国）和 2%（其他国家）的试验发布了 ICF。当分析中考虑到主要完成日期后最后 2 个月和 12 个月的差距时，ICF 发布率没有变化，但美国试验的结果发布率增加到 64%。与行业相比，“美国联邦机构”资助的试验更有可能发布 ICF [OR 23.9（12.5-45.7）；<.001]或“其他所有人”[OR 3.16（1.79-5.56）；<.001]。
结论
应考虑采取未来干预措施，鼓励及时发布试验结果和信息。
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