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经验和挑战与新的欧洲临床试验法规

Thale D J H Patrick-Brown¹, Josephine Bourner², Sabrina Kali³

¹Clinic for Surgery, Inflammatory Medicine and Transplantation (KIT Research), Oslo University Hospital, Oslo, Norway. d.j.patrick-brown@medisin.uio.no.

|January 3, 2024

概括

欧洲新的临床试验信息系统 (CTIS) 没有降低临床试验的行政负担,尽管有承诺. 延误和技术问题阻碍了研究,特别是疫情防控.

科学领域:

临床研究法规临床研究法规
欧洲药品管理局 (EMA) 是欧洲药品管理局.
传染病研究传染病研究.

背景情况:

欧洲药品署 (EMA) 根据临床试验法规 (CTR EU 536/2014) 于2022年1月31日实施临床试验信息系统 (CTIS).
CTIS的目的是简化欧洲范围内的临床试验注册流程.
这项研究利用了三项欧洲跨国研究的经验,这些研究重点关注易爆发的传染病.

研究的目的:

评估新的CTIS提交程序的优缺点.
评估CTIS对跨国临床研究的实际影响.
确定欧洲临床试验监管框架的挑战和需要改进的领域.

主要方法:

对三项多国欧洲研究的监管和伦理审批的时间分析.
评估申请档案的大小和信息请求 (RFI) 的数量.
使用CTIS对欧盟和非欧盟监管环境中的研究经验进行定性评估.

主要成果:

虽然审批时间有所改善,但审批时间仍然很慢,特别是在与疫情相关的研究中.
发现了相互冲突的申请要求,增加的文件负担和提交障碍.
在CTIS平台中遇到重大技术障碍和削弱性问题.

结论:

CTIS尚未实现其减少临床试验行政负担的目标.
迫切需要改进,以解决系统的局限性和延误.
当前系统的低效性给跨国研究带来了挑战,特别是在疫情防控和应对方面,这引发了伦理方面的担忧.

关键词:

临床试验临床试验是指临床试验的临床试验.流行病流行病流行病政府监管政府法规.多中心试验的多中心试验.流行病是一种流行病.

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