预测定期安全更新报告的提交频率:开发和应用EURD工具
María Gordillo-Marañón1,2, Gianmario Candore1, Marta López-Fauqued3
1Healthcare Data Workstream, Data Analytics and Methods Task Force, European Medicines Agency, Amsterdam, Netherlands.
Frontiers in medicine
|February 23, 2024
概括
新的统计方法EURD工具预测了药物的定期安全更新报告 (PSUR) 频率. 这种数据驱动的方法确保了监管机构的一致基于风险的评估和可管理的工作负载.
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
- 生物统计学 生物统计学
背景情况:
- 定期安全更新报告 (PSUR) 对于评估药物获准后的药物益处风险平衡至关重要.
- 目前的PSUR提交频率是个别确定,缺乏基于风险的标准化方法.
- 对于欧洲药品监管网络 (EMRN) 等监管网络来说,有效的工作负载管理至关重要.
研究的目的:
- 开发和应用EURD工具,一种用于预测PSUR频率的统计方法.
- 建立一个一致的,数据驱动的,基于风险的方法来确定PSUR频率.
- 评估预测频率对监管工作负载的影响.
主要方法:
- 从欧洲药物局数据源中识别相关变量.
- 与国家主管当局进行调查,以优先考虑变量并提出频率.
- 开发回归模型,应用于更大的物质清单,并通过专家调查进行验证.
主要成果:
- 欧元网工具应用于1032条条目,预测PSUR频率.
- 分析表明,所有条目可以在2038年之前进行审查,平均年工作量增加15%.
- 拟议的频率旨在优化EMRN内的审查过程.
结论:
- 该工具是第一个数据驱动的应用程序,支持PSUR频率决策.
- 它为欧盟授权的物质分配PSUR提交频率提供了潜在的改进.
- 其他需要定期评估安全数据和工作负载平衡的机构也可以从这种方法中受益.
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