药品临床综合评价主题选指南
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《药品临床综合评价主题选指南》项目组
中图分类号R95 文献标志码A 文章编号 1001-0408（2025）08-0897-06
DOI 10.6039/j.issn.1001-0408.2025.08.01
Guidelines for topic selection for comprehensive clinical evaluation of drugs Project Team of Guidelines for Topic Selection for Comprehensive Clinical Evaluation of Drugs
ABSTRACTOBJECTIVETo promote thestandardizedandhigh-qualitydevelopmentofcomprehensiveclinicaldrug evaluation， and enhace thequalityofcomprehensiveevaluationevidenceanditsapplicationtransformationvalueMETHODSThe guidelines werforulatedinaccrdancewiththelatestdefinitionofguidelinesprovidedbytheInsttuteofMedicineoftheNationalAcademy ofSciencesandbasedonthemethodologyestablishedbytheWorldHealthOrganizationstandardguidelinesAnindexsystemfor topicselectionwasconstructedusingtheDelphimethod，andweightsforeachindexwereasignedthroughtheanalytic hierarchy process.Researchevidencewasestablishedfollwing the principlesofevidence-basedmedicineTheevidencegrading evaluation wasconductedusing theevidence grading systemof the ChinaEvidence-BasedMedicine Center，andrecommendationopinions wereformed viaexpertconsensus.RESULTSGuidelines forTopic Selection forComprehensive ClinicalEvaluationof Drugs （hereinafterreferredtoas“theuidelines"）were sucessullydeveloped，encompassingtheorganizationandmanagementoftoic selectioneviewprocesesandealuatinmethodsTheevaluatinindexsstemforopicelectionwasestablished，mprising primary indexes，9secondary indexes，and17tertiary indexes.CONCLUSIONSThedevelopment of the Guidelines providesa standardizedtopicelectionolfortheproposedresearchworkofclinicalcomprehensiveevaluationofdrugsenhancesthequality of evaluations， facilitates result transformation， and supports scientific health decision-making.
KEYWORDSclinical comprehensive evaluation of drugs；topic selection； guideline； evaluation index system
药品临床综合评价是药品供应保障决策的重要技术工具。（剩余11708字）