在试验中补偿患者:伦理委员会的观点与赞助商的观点
Laure Peyro-Saint-Paul1, Cathy Gaillard1, Adeline Paris2
1Pharmacovigilant, Responsable de lunite de vigilance des essais cliniques (UVEC), Direction de la Recherche et de l'innovation, CHU Caen Normandie, Caen, France.
European journal of clinical investigation
|June 22, 2023
概括
尽管有道德准则,但在临床试验中很少提供患者补偿. 外部伦理审查发现,建议和实际的经济补偿之间存在重大差异,强调需要更明确的指导方针.
科学领域:
- 临床研究伦理学
- 临床试验中的患者补偿
- 药物开发中的监管合规性
背景情况:
- 欧洲临床研究立法要求不对参与试验产生不当影响.
- 参与临床试验的财政激励措施应反映患者的不便.
- 赞助商负责确定患者的经济补偿.
研究的目的:
- 评估临床试验中患者经济补偿的充分性.
- 将实际赔偿与外部道德意见进行比较.
- 发现财务补偿评估中的差异.
主要方法:
- 50个临床药物试验的随机选择和审查 (25个学术,25个行业赞助).
- 由外部伦理小组 (法国伦理委员会三名成员) 进行研究特征的回顾性评估.
- 使用科恩的卡帕和麦克内马尔测试来测量协议和差异的统计分析.
主要成果:
- 实际财务补偿和道德小组意见之间没有一致 (Kappa = -0.07).
- 伦理小组建议更多的补偿 (12/50) 比赞助商提供 (2/50).
- 建议的补偿与更多的访问和行业赞助相关;实际的补偿很少提供.
结论:
- 患者很少因参与试验而获得补偿,尽管他们觉得不方便.
- 赞助商和道德委员会在确定适当的财务补偿方面面临着挑战.
- 需要准确的建议来指导赞助商和伦理委员会对患者赔偿.
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