医疗机构药品临床综合评价的质量控制

Quality control of clinical comprehensive evaluation in medical institutions

国家卫生健康委员会已于2021年7月下发《药品临床综合评价管理指南(试行)》,文件为药品临床综合评价工作提供指导原则。虽然在指南中明确评价流程、内容及维度,强调证据评价和应用、证据信息及评价质量控制,但质量控制的详细内容与标准尚需探索。该文从文献综述、原始研究、经济性研究及调研访谈四个角度提出医疗机构药品综合评价运行的质量控制体系,希望能为医疗机构的药品临床综合评价应用提供参考。

The National Health Commission has issued the Guidelines for the Management of Clinical Comprehensive Evaluation(Trial)in July 2021 to provide guiding principles for the clinical comprehensive evaluation of drugs.Although the evaluation process,content and dimension are clearly defined in the guide,and the evidence information and evaluation quality control for evidence evaluation and application are emphasized,the detailed content and standards of quality control still need to be explored.This paper proposed a quality control system for clinical comprehensive evaluation of drugs in medical institutions from the perspectives of literature review,original research,economic research and investigation,hoping to provide references for the clinical application of drug comprehensive evaluation in medical institutions.