国内外药品上市后安全性研究的方案制定要求比较

Key Components Comparison on Protocols for Drug Post-authorization Safety Study among Different Authorities

对于药品上市后临床试验或安全性研究,事先制定并严格执行标准操作程序或研究方案是研究全过程监管及结果质量保证的重要途径。我国及其他发达国家均已在药品上市后安全性相关法律规章或指南性文件中提出研究方案的相关规范要求,但内容详略程度及提及指标完整度等方面不尽相同。本文从研究方案的核心要素(包括方法学描述、数据管理与统计分析计划等模块)着手,系统梳理各国及国际组织权威性文件研究方案撰写异同,为完善我国药品上市后安全性研究方案的制定提供借鉴思路。

Drawing up a standard operating procedure and/or protocol ex ante then strictly implementing the post-authorization safety study/clinical trial(PASS)accorded with the former would guarantee the full-chain supervision and results’reliability.Standardized requirements on PASS protocols have been proposed in related laws,regulations or guidance documents both home and abroad,however,existence of detailed information and completeness of key components listed in protocol requirements differ greatly.Authoritative documents on PASS protocols among different agencies would be systematically sorted out to compare the key components required in protocols(including modules such as methodological description,data management and statistical analysis plan).This would give inspired ideas on modifying PASS protocol requirements in China.