在临床药物试验中,认知安全在很大程度上被忽视:对注册研究协议的研究
Arne Reimers1,2, Hanna Ljung3
1Division of Clinical Chemistry and Pharmacology, Department of Laboratory Medicine, Faculty of Medicine, Lund University, 221 85, Lund, Sweden. arne.reimers@med.lu.se.
Drug safety
|November 16, 2023
概括
药物诱导的记忆障碍越来越令人担忧,但临床试验很少评估认知安全性. 这项研究发现,最近的试验中只有6.5%积极评估认知功能,突出了药物安全研究中的关键差距.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 临床研究方法论 临床研究方法论
- 神经科学是一个神经科学.
背景情况:
- 药物诱导的认知障碍是可逆性痴呆症的一个重要原因.
- 在2000年至2022年期间,对FDA提出的疑似药物诱导的记忆障碍报告增加了30倍.
- 尽管药物引起的认知障碍很普遍,但对药物引起的认知障碍的研究仍然有限.
研究的目的:
- 评估认知安全评估在注册的,受控的临床药物试验中的包括和方法.
- 识别不同药物类别和试验阶段认知安全评估的趋势.
主要方法:
- 随机对照临床试验的系统审查,使用来自主要注册表的可用协议.
- 用于认知安全评估方法的803个选定的试验协议的手动审查.
- 药物的分类 (中枢神经系统向与非中枢神经系统向,旧与新) 和评估方法 (问卷,查,神经心理测试).
主要成果:
- 在803个试验中,只有52个 (6.5%) 试验积极评估认知安全;其余的依赖于自发报告.
- 即使对于新药 (7.5%) 和中枢神经系统 (CNS) 药物 (13.5%),积极认知安全评估也很低.
- 在评估时,认知功能通常使用基本查工具或问卷进行评估.
结论:
- 最近的受控临床试验在很大程度上忽视了认知安全评估.
- 这种监督甚至在涉及新药和针对中枢神经系统的药物试验中仍然存在.
- 制药公司,监管机构和临床医生迫切需要优先考虑与药物相关的认知安全.
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