在clinicalTrials.gov上发布知情同意表格的行业资助试验的主要特征:跨部门分析
Rafael Dal-Ré1, Ignacio Mahillo-Fernández2
1Biostatistics and Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Avda Reyes Católicos 2, Madrid, ES-28040, Spain. rafael.dalre@quironsalud.es.
The AAPS journal
|June 18, 2024
概括
工业资助的临床试验很少发布知情同意表 (ICF),但那些确实展示了高透明度的临床试验. 对于所有试验,应考虑对协议,统计分析计划 (SAP) 和ICF的发布要求.
科学领域:
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
- 监管科学 监管科学
背景情况:
- 工业资助的临床试验对于医学进步至关重要.
- 临床试验文档的透明度,包括知情同意表 (ICF),对于道德行为和公众信任至关重要.
- 行业的作用 (赞助商与合作者) 可能会影响试验透明度实践.
研究的目的:
- 描述已发布ICF的行业资助的试验.
- 评估行业作为"赞助商"或"合作者"的作用是否会影响ICF和其他试验变量的发布.
- 评估ICF后的行业资助试验的透明度合规性.
主要方法:
- 在2023年2月25日之前在ClinicalTrials.gov注册的行业资助的试验的横截面研究.
- 试验特征的分析,包括干预类型,招募状态,设计,招生和参与的国家.
- 具体分析行业作为"赞助商"或"合作者"在试验样本中的作用.
主要成果:
- 在行业资助的试验中,只有0.6% (741分116,281) 发布了ICF.
- 工业作为"合作者"的试验更有可能发布ICF,特别是在"积极,不招募"阶段和药物/生物制剂.
- 与合作者相比,工业"赞助商"更有可能发布ICF用于涉及设备,辐射或诊断测试的试验.
结论:
- 工业资助的试验很少发布ICF,但当他们这样做时,会显示出高度的透明度.
- 产业的作用 (赞助商与合作者) 影响了ICF的部署可能性.
- 建议包括考虑强制发布所有临床试验的协议,SAP和ICF.
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