在日本,监管要求的营销后数据库研究可以被利用来评估重要的潜在风险以及已识别的风险
Hiroshi Yamazaki1, Ko Nakajo1, Naoki Hirose1
1Global Epidemiology, Johnson & Johnson, Tokyo, Japan.
Frontiers in pharmacology
|August 5, 2025
概括
在日本的营销后数据库研究 (PMDS) 主要使用对特定风险的队列设计. 加强对潜在风险和罕见事件的使用,可以改善药物监测.
科学领域:
- 药监和药物安全 药监和药物安全
- 流行病学 流行病学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 风险管理计划 (RMP) 在日本对药品的营销后监测至关重要.
- 营销后数据库研究 (PMDS) 是风险管理计划的组成部分,提供有关药物安全性和有效性的真实数据.
- 在RMP中了解PMDS的特征对于优化药监策略至关重要.
研究的目的:
- 描述在日本所有治疗领域的风险管理计划 (RMP) 中包含的营销后数据库研究 (PMDS) 的情况.
- 在日本RMP中分析PMDS的研究设计,目标和数据源.
- 确定提高PMDS在药物监测中的利用和科学价值的机会.
主要方法:
- 从制药和医疗器械局网站 (从2013年4月至2023年12月) 系统和独立审查所有风险管理计划.
- 根据研究设计,目标目标和数据源,识别,审查和总结PMDS.
- 将具体研究目标与所使用的数据源联系起来.
主要成果:
- 在63个RMP中确定了85个PMDS,目标是138个安全和5个有效性目标.
- 大多数PMDS (67.1%) 关注重要已识别的风险,较少的PMDS (34.1%) 关注重要潜在风险.
- 队列研究是主要的设计 (87.1%),经常包括对照组 (74.1%). 共同的安全目标包括感染,代谢,心脏和血管疾病.
- 医疗数据视觉数据库是最常用的数据源 (37.5%),其次是MID-NET® (21.2%) 和JMDC (10.6%).
结论:
- 在RMP中,日本的PMDS主要采用针对已识别风险的队列设计.
- 通过优化研究设计和数据源利用,有可能更好地利用PMDS评估潜在风险和罕见不良事件.
- 更早地向公众提供PMDS协议可以提高研究方法和这些研究对日本药物监督的整体科学贡献.
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