藥品臨床綜合評(píng)價(jià)主題選指南

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《藥品臨床綜合評(píng)價(jià)主題選指南》項(xiàng)目組

中圖分類號(hào)R95 文獻(xiàn)標(biāo)志碼A 文章編號(hào) 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

藥品臨床綜合評(píng)價(jià)是藥品供應(yīng)保障決策的重要技術(shù)工具。（剩余11708字）