我们的目标是描述发布知情同意书(ICF)的行业资助试验,并评估行业作为“赞助者”或“合作者”所扮演的角色是否会影响几个相关变量。在ClinicalTrials.gov上对2023年2月25日或之前注册的所有行业资助的试验进行了横断面研究。我们记录了干预的类型,目前的招聘状态,设计,招生,和参与的国家。对于潜在参与者和研究者和/或临床医生特别感兴趣的试验,对行业作为“赞助者”或“合作者”所扮演的角色进行了分析。在注册的116,281项行业资助的试验中,741(0.6%)发布了ICF。这些试验大多数被归类为“完成”(n=408)或“终止”(n=107)。对359项试验样本的审查显示,大多数是关于药物和/或生物制剂(59%),随机化(51%),仅在美国进行(72%),并公布了结果(79%),协议(92%),和统计分析计划(SAP)(89%)。当试验处于活跃状态时,行业作为“合作者”参与的试验更有可能发布ICF,与行业赞助的试验相比,未招募阶段(OR4.70,99.71%CI1.59-13.9,p<0.001)。在评估药物/生物制剂时也是如此(OR2.64,99.71%CI1.25-5.58,p<0.001)。相反,作为“赞助商”的公司更有可能发布带有试验评估设备的ICF,辐射干预和/或诊断测试(OR0.37,99.71%CI0.17-0.79,p<0.001)比作为“合作者”参与时。虽然行业资助的试验很少发布ICF,当他们这样做的时候,他们高度符合透明度要求。法规和道德守则应考虑要求发布协议,SAP,以及所有临床试验的ICFs,无论赞助商的类型。
We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as \'sponsor\' or \'collaborator\' could impact several relevant variables. A cross-sectional study was conducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as \'sponsor\' or \'collaborator\' was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as \'completed\' (n = 408) or \'terminated\' (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as \'collaborator\' were significantly more likely to post ICFs when trials were in the \'active, not recruiting\' phase (OR 4.70, 99.71% CI 1.59-13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25-5.58, p < 0.001). Conversely, companies acting as \'sponsors\' were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17-0.79, p < 0.001) than when participating as \'collaborators\'. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor.