摘要
我国药品临床综合评价工作目前还存在诸如评价内容设计不科学、评价方法和组织流程欠规范、评价结果无法满足决策需求等问题,亟须对药品临床综合评价项目的全过程进行质量控制。本文从技术角度出发,从评价内容与设计(给出主题遴选流程和方案设计的质量控制要点)、评价方法(探讨2种常用评价方法——文献证据法和真实世界研究的质量控制要素)、结果应用转化(从评价结果综合分析、评价结果转化与决策两方面给出质量控制的建议)3个环节探讨药品临床综合评价的质量控制方法,拟促进该项工作的质量提升。
At present, there are still some problems in China’s clinical comprehensive drug evaluation, such as the unscientific design of the evaluation content, the nonstandard evaluation method and organizational process, and the evaluation results not meeting the decision-making needs. It is urgent to carry out quality control over the whole process of the clinical comprehensive drug evaluation project. From the technical point of view, the quality control methods of clinical comprehensive drug evaluation are discussed through three links of the evaluation content and design(giving the quality control key points of the theme selection process and scheme design), the evaluation method(discussing the quality control elements of two common evaluation methods, i. e. documentary evidence method and real-world research) and result application transformation(giving suggestions on quality control from the comprehensive analysis of evaluation results, transformation of evaluation results and decision-making), so as to promote the quality improvement of clinical comprehensive drug evaluation.
作者
王舒
董名扬
陈朋军
菅凌燕
WANG Shu;DONG Mingyang;CHEN Pengjun;JIAN Lingyan(Dept.of Pharmacy,Shengjing Hospital of China Medical University,Shenyang 110004,China)
出处
《中国药房》
CAS
北大核心
2023年第3期275-279,共5页
China Pharmacy
基金
中国博士后科学基金面上资助项目(No.2022MD-713822)
中国医科大学附属盛京医院“345人才工程”项目。
关键词
药品临床综合评价
技术方法
质量控制
clinical comprehensive drug evaluation
technical method
quality control
