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关于实施注册表的政策建议,以尽量减少在I期临床试验中的过度志愿者

Roberto Abadie¹, Jill A Fisher², Shadreck Mwale³

¹Department of Kinesiology, School of Education, University of Wisconsin-Madison, Madison, WI, USA.

Clinical trials (London, England)

|July 29, 2025

概括

参与多项临床试验的健康志愿者可能会因过度志愿而受到伤害. 实施强制性注册对于志愿者安全和可靠的研究结果至关重要.

科学领域:

临床研究临床研究
药物开发药物开发
公共卫生公共卫生

背景情况:

每年有成千上万的健康志愿者参加I期临床试验,通常是为了获得经济激励.
过度的志愿服务,包括同时参与或跳过洗期,对志愿者和数据完整性构成风险.
第一阶段试验,特别是首次在人体上进行的试验,具有固有的,不可预测的风险,这些风险可以通过未披露的多重试验参与而被放大.

研究的目的:

突出在I期临床试验中过度志愿服务的风险.
检查当前临床试验登记册的情况,以对志愿者进行监督.
倡导广泛采用强制性登记册,以提高志愿者安全和研究可靠性.

主要方法:

对现有文献和案例的审查,涉及志愿者过度参与临床试验.
分析目前在不同国家实施的国家和私人注册系统.
讨论实施强制性临床试验注册表的障碍和促进因素.

主要成果:

虽然一些国家和私人实体使用注册表,但追踪临床试验招生的强制性系统并未被普遍采用.
过度志愿服务可能会导致不良事件的增加和受损的试验数据,由于潜在的药物相互作用.
现有的注册表在范围和强制执行方面各不相同,许多国家缺乏全面的监督.

结论:

广泛采用强制性临床试验注册表对于保护健康志愿者免受潜在伤害至关重要.
注册表提高了临床试验结果的透明度,可靠性和完整性.
实施强大的注册系统对于开发更安全,更有效的药物至关重要.

关键词:

第一期临床试验临床试验.障碍物障碍物障碍物伦理学伦理伦理学人类志愿者是人类志愿者.实施实施实施实施实施.过度的志愿服务.登记处登记处登记处登记处

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