中国药房2025，Vol.36Issue(8)：897-902,6.DOI:10.6039/j.issn.1001-0408.2025.08.01
药品临床综合评价主题遴选指南
Guidelines for topic selection for comprehensive clinical evaluation of drugs
摘要
Abstract
OBJECTIVE To promote the standardized and high-quality development of comprehensive clinical drug evaluation,and enhance the quality of comprehensive evaluation evidence and its application transformation value.METHODS The guidelines were formulated in accordance with the latest definition of guidelines provided by the Institute of Medicine of the National Academy of Sciences and based on the methodology established by the World Health Organization standard guidelines.An index system for topic selection was constructed using the Delphi method,and weights for each index were assigned through the analytic hierarchy process.Research evidence was established following the principles of evidence-based medicine.The evidence grading evaluation was conducted using the evidence grading system of the China Evidence-Based Medicine Center,and recommendation opinions were formed via expert consensus.RESULTS Guidelines for Topic Selection for Comprehensive Clinical Evaluation of Drugs(hereinafter referred to as"the Guidelines")were successfully developed,encompassing the organization and management of topic selection,review processes,and evaluation methods.The evaluation index system for topic selection was established,comprising 5 primary indexes,9 secondary indexes,and 17 tertiary indexes.CONCLUSIONS The development of the Guidelines provides a standardized topic selection tool for the proposed research work of clinical comprehensive evaluation of drugs,enhances the quality of evaluations,facilitates result transformation,and supports scientific health decision-making.关键词
药品临床综合评价/主题遴选/指南/评估指标体系Key words
clinical comprehensive evaluation of drugs/topic selection/guideline/evaluation index system分类
药学引用本文复制引用
《药品临床综合评价主题遴选指南》项目组,李正翔..药品临床综合评价主题遴选指南[J].中国药房,2025,36(8):897-902,6.基金项目
白求恩·求索-药学科研能力建设项目(No.B-19-H-20200622) （No.B-19-H-20200622）
