西班牙的低干预临床试验:它们有进展吗?
Claudia Erika Delgado-Espinoza1,2,3, Mayro J Cortés Pestana1,2,3, Kristopher Amaro1,2,3
1Department of Pharmacology and Therapeutics, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
低干预临床试验 (LICTs) 仍然是西班牙研究的一小部分,主要是非商业性和评估经批准的药物. 它们的设计可以更强大,但最近的监管变化对LICT活动没有影响.
科学领域:
- 临床药理学 临床药理学
- 监管科学是一种监管科学.
- 医疗服务研究 医疗服务研究
背景情况:
- 低干预临床试验 (LICTs) 是对经授权药物的实用研究.
- 2014年,为支持非商业临床试验 (NCCT) 引入了简化规定.
- 2023年实施临床试验信息系统 (CTIS) 可能会影响LICT的可行性.
研究的目的:
- 描述2014年至2023年在西班牙批准的LICT的特性.
- 评估监管变化和CTIS对LICT的影响.
主要方法:
- 对LICTs进行横截面描述性分析.
- 来自西班牙临床研究注册表 (REec) (2014-2023) 的数据.
主要成果:
- 在所有注册的试验中,LICTs占3.8% (322/8497).
- 大多数LICT都是非商业性赞助,第四阶段,单心,并评估授权药物.
- 疗效/安全是主要目标;药物经济学和生物等价性不太常见. 设计通常是随机的,但很少是盲目的或安慰剂控制的.
结论:
- LICTs对于现实世界的证据至关重要,但在西班牙的试验中仍然占很小比例.
- 在LICT设计中,在强度方面还有改进的余地.
- 在2023年,CTIS的实施似乎不会影响LICT活动.
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