GCP驻科药师在皮肤病专业药物临床试验管理中的实践路径与效果评价

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中图分类号R95；R969.4 文献标志码A 文章编号 1001-0408（2025）20-2507-05

DOI10.6039/j.issn.1001-0408.2025.20.04

Practice pathway and efectiveness evaluation of GCP resident pharmacists in the management of dermatological drug clinical trials

WANG Yunlong， ZHOU Limin，ZHANG Hua，LI Quanchao （Dept. of Pharmacy，Nanyang First People’sHospital，Henan Nanyang 473010，China）

ABSTRACTOBJECTIVEToexplore the practice pathwayandevaluatetheefectivenessof theresident pharmacistsstationed in theDrugClinicalTrialInstitutionOfice（hereinafterreferredtoasthe“GCPresidentpharmacist”）inthemanagementof dermatologicaldrugclinicaltrials.METHODsThepracticalapproachofGCPresidentpharmacistsparticipating indermatological drugclinicaltrialsatourhospitalwasintroducedAretrospectiveanalysiswasconductedonthedataofdermatologicaldrugcliical trialsfrom2021to2024，comparingeficiencyandqualityindicatorsbetweendermatologicalclinicaltrialsandthoseofother specialties.RESULTSWiththeinvolvementofourhospital’sGCPresidentpharmaciststhroughout，theprocessfordermatology drugclinical trials wasconstructedandotimized，adedicatedqualitycontrolsystem was established，andtheaccelerationstrategy forsubjectenrollmentwasoptimized.Thenumberofermatologicaldrugclinical tralsatourhospitalshowedacompoundanual growth rate of 69.56% from 2021 to 2023.In terms of efficiency indicators，theapproval waiting time for dermatological drug clinical trials was（ （12.31±4.99） days，which was significantly shorter than that of other specialties[ （19.68±6.09） days， P<0.05⋅ 一 Regarding quality indicators，the enrollment rate for dermatological drug clinical trials was 75.71%（50.00%，114.48%） ，which was significantly higher than that of other specialties [51.00%（25.00%，174.17%） ， P<0.05] . The numbers of first quality control issues [ （8.31±3.25） itemsvs. （11.68±4.49 ）items]and protocol deviations [5.5（2.0，11.0）times vs.11.0（5.5，17.5）times] were significantly lower than those of other specialties ⋅P<0.05 ）.CONCLUSIONS GCP resident pharmacists significantly enhance the overall efficiencyofdermatologicaldrugclinicaltrials，playingacrucialroleinensuringthereliabilityandauthentityofdrugcliical trials，as well as safeguarding the rights and safety of trial subjects.

KEYWORDS GCP resident pharmacist；drug clinical trials；dermatological specialty；quality control

国家于2019年采取药物临床试验机构备案制管理后，国内药物临床试验机构不断增加，截至2024年底，药物临床试验机构备案管理信息平台显示的药物临床试验备案机构有近1700家[1-2]。（剩余8852字）