对临床试验参与者进行高风险,不可逆转治疗的评估,需要更多的试验后支持
Alex Harris1, Frederic Gilbert2
1Department of Biomedical Engineering, The University of Melbourne, Melbourne, Victoria, Australia alexrharris@gmail.com.
Journal of medical ethics
|June 4, 2024
概括
高风险研究中的临床试验参与者可能在没有保证支持的情况下面临长期伤害. 未来的试验设计必须解决参与者的持续健康和试验后的需求.
科学领域:
- 临床研究伦理学
- 患者倡导 患者倡导
背景情况:
- 越来越多的临床试验涉及高风险,不可逆转的治疗方法.
- 这些试验的参与者主要是为社会知识做出贡献,而不是个人治疗收益.
- 潜在的长期参与者伤害和排除从未来的治疗存在.
研究的目的:
- 要强调缺乏对经历长期后果的参与者进行审判后支持.
- 倡导将试验后支持纳入临床试验设计.
- 解决试验参与者的医疗,心理,社会,技术和财务需求.
主要方法:
- 审查当前的临床试验实践和伦理考虑.
- 对试验参与者的潜在长期影响的分析.
- 讨论审判后护理的伦理义务.
主要成果:
- 目前的审判后支持主要集中在那些受益者获得治疗的机会上,忽视了那些长期受到伤害的人.
- 在试验结束后,参与者可能会面临重大未满足的需求.
- 缺乏确定的要求,以解决参与者在试验后的福祉问题.
结论:
- 临床试验,特别是那些具有高风险治疗的临床试验,必须包含全面的试验后支持计划.
- 试验设计应主动考虑所有参与者的长期健康和支持需求.
- 伦理试验行为需要解决参与者后果的全部范围,包括长期伤害.
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