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《药品临床综合评价工作流程指南》团体标准解读
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| 篇名： | 《药品临床综合评价工作流程指南》团体标准解读 |
| TITLE： | Interpretation of the group standard of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs |
| 摘要： | 为规范药品临床综合评价工作流程，加强研究证据的评价及研究成果应用转化价值，中国药师协会于2025年6月发布了《药品临床综合评价工作流程指南》团体标准（T/CLPA5-2025），核心要点包括明确药品临床综合评价的概念以及规范主要工作流程和技术要点。本文针对该标准的制定技术方法、4个核心环节（主题遴选、评价实施、证据评价、结果应用转化）操作逻辑、核心技术要点等进行详细解读，旨在帮助医疗机构技术人员、政策制定者及科研人员准确把握该标准内涵，解决实践中流程衔接、技术应用等困惑，提升评价工作质量与同质化水平，为卫生健康决策科学化、临床用药合理化提供支撑。 |
| ABSTRACT： | In order to standardize the workflow for the clinical comprehensive evaluation of drugs， enhance the assessment of research evidence， and improve the application value of research outcomes in translational practice， the Chinese Pharmaceutical Association issued the Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs （T/CLPA 5-2025） in June 2025. The core points include clarifying the concept of clinical comprehensive evaluation of drugs and standardizing the main work processes and technical essentials. This article provides a detailed interpretation of the technical methods for standard formulation， the operational logic of the four core processes （theme selection， evaluation implementation， evidence evaluation， result application transformation）， and the key points of core technologies. The aim is to assist medical institution technicians， policymakers and researchers in accurately grasping the connotation of the standards， resolving practical concerns such as process connection and technology application， and enhancing the quality and homogenization of evaluation work. It provides support for the scientific decision-making of healthcare and health， and the rational clinical medication. |
| 期刊： | 2025年第36卷第23期 |
| 作者： | 段蓉；李正翔 |
| AUTHORS： | DUAN Rong，LI Zhengxiang |
| 关键字： | 药品临床综合评价；工作流程指南；团体标准；解读 |
| KEYWORDS： | clinical comprehensive evaluation of drugs； guideline for the workflow； group standard； interpretation |
| 阅读数： | 2 次 |
| 本月下载数： | 0 次 |
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