Biostatistics and Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Avda Reyes Católicos 2, Madrid, ES-28040, Spain.
AAPS J. 2024 Jun 18;26(4):72. doi: 10.1208/s12248-024-00943-5.
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.
我们旨在描述已发布知情同意书 (ICF) 的行业资助试验，并评估行业作为“赞助商”或“合作者”所扮演的角色是否会影响几个相关变量。在 ClinicalTrials.gov 上对截至 2023 年 2 月 25 日注册的所有行业资助试验进行了横断面研究。我们注册了干预类型、当前招募状态、设计、入组和涉及的国家。对于对潜在参与者和调查员和/或临床医生具有特殊兴趣的试验，我们分析了行业作为“赞助商”或“合作者”所扮演的角色。在注册的 116,281 项行业资助试验中，有 741 项（0.6%）已发布 ICF。这些试验大多被归类为“已完成”（n=408）或“已终止”（n=107）。对 359 项试验的样本进行审查表明，大多数试验是关于药物和/或生物制剂（59%）、随机（51%）、仅在美国进行（72%），并且已经发布了结果（79%）、方案（92%）和统计分析计划（SAP）（89%）。当试验处于“活跃但不招募”阶段时，行业作为“合作者”参与的试验发布 ICF 的可能性明显高于行业赞助的试验（OR 4.70，99.71%CI 1.59-13.9，p<0.001）。当评估药物/生物制剂时也是如此（OR 2.64，99.71%CI 1.25-5.58，p<0.001）。相反，作为“赞助商”行事的公司发布 ICF 的可能性明显高于参与“合作者”的公司，发布评估设备、辐射干预和/或诊断测试的试验（OR 0.37，99.71%CI 0.17-0.79，p<0.001）。尽管行业资助的试验很少发布 ICF，但当它们发布时，它们高度符合透明度要求。法规和伦理准则应考虑要求发布所有临床试验的方案、SAP 和 ICF，无论赞助商类型如何。
