《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 ......