药品风险最小化评价研究报告规范解读

Interpretations of reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES)statement

目的通过介绍国际药品风险最小化评价研究(pharmaceutical risk minimization evaluation studies,RIMES)报告规范(RIMES报告规范)条目并开展实例解读,帮助实施者和读者更好理解并应用RIMES清单工具。方法总结药品风险最小化项目的特点及研究现状,同时基于翻译完整过程(translation integrity procedure,TIP)经过前向、后向对译等多环节,完成RIMES清单翻译并开展实例解读。结果梳理RIMES清单所包含的关键信息、研究设计、实施和评价等4个维度共43个条目。结论随着全球药物警戒管理机构进一步的推行,RIMES报告规范将为RIMES提供重要的框架指导。

Objective To help implementers and readers better understand and apply the reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES)statements by introducing the checklist of RIMES statements and interpreting them.Methods The characteristics and current research of RIMES were summarized.Meanwhile,the checklist of RIMES statements was translated based on the translation integrity procedure(TIP)through forward and backward translation.Results There were 43 items in the RIMES checklist in four dimensions,including key information,research design,implementation and evaluation.Conclusion With the increasing regulators of global pharmacovigilance,RIMES statements will provide an important framework for RIMES.