时间间隔的持续时间 降低风险的时间间隔 降低风险的时间间隔 衡量效果研究 效果研究
Sharon C M Essink1,2, Inge M Zomerdijk2, Thomas Goedecke3
1Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Clinical pharmacology and therapeutics
|January 24, 2025
概括
在授权后安全研究 (PASS) 中评估风险最小化措施 (RMM) 的有效性需要四年时间. 在研究请求和启动之间出现了最长的延迟,这凸显了需要改进的指导和及时提交协议的需要.
科学领域:
- 药监和药物安全 药监和药物安全
- 监管科学 监管科学
- 制药政策 制药政策
背景情况:
- 对药物的监管监督需要对风险最小化措施 (RMMs) 的有效性进行严格的评估.
- 授权后安全研究 (PASS) 对于在现实环境中评估RMM至关重要.
- 了解RMM有效性研究的时间表可以识别监管过程中的瓶.
研究的目的:
- 评估RMM有效性研究的关键监管里程碑之间的时间间隔.
- 为了确定RMM有效性评估中最耗时的阶段,PASS.
- 为优化RMM有效性评估过程提供见解.
主要方法:
- 追溯分析2016年至2022年期间由欧洲药品署药监风险评估委员会 (PRAC) 评估的完成的RMM有效性PASS.
- 从EMA数据库中提取监管文件日期.
- 计算研究请求,协议评估,研究开始和最终研究报告评估之间的时间长度.
主要成果:
- 从研究请求到RMM有效性PASS的最终PRAC结果的中位持续时间为52个月 (超过4年).
- 从研究请求到研究开始的时间平均为21个月,这代表了显著的时间滞后.
- 对采用已批准的方案进行的研究的协议评估平均需要7个月的时间.
结论:
- 评估RMM有效性的总体时间表大大超过了四年.
- 研究前阶段 (研究开始请求) 是延长持续时间的主要贡献者.
- 改进指导和鼓励及时提交协议可以加快对RMM有效性的评估.
相关概念视频
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