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1、DataMonitoringinClinicalTrialsDavidL.DeMetsCurtD.FurbergLawrenceM.FriedmanEditorsDataMonitoringinClinicalTrialsACaseStudiesApproachWith40IllustrationsDavidL.DeMetsCurtD.FurbergDepartmentofBiostatisticsandMedicalDepartmentofPublicHealthSciencesInformaticsWakeForest
2、UniversitySchoolUniversityofWisconsinMedicalSchoolofMedicineMadison,WI53972-4675Winston-Salem,NC27157USAUSALawrenceM.FriedmanBethesda,MDUSALibraryofCongressControlNumber:ISBN-10:0-387-20330-3Printedonacid-freepaper.ISBN-13:978-0387-20330-0©2006SpringerScience+Busi
3、nessMedia,Inc.Allrightsreserved.Thisworkmaynotbetranslatedorcopiedinwholeorinpartwithoutthewrittenpermissionofthepublisher(SpringerScience+BusinessMedia,Inc.,233SpringStreet,NewYork,NY10013,USA),exceptforbriefexcerptsinconnectionwithreviewsorscholarlyanalysis.Usei
4、nconnectionwithanyformofinformationstorageandretrieval,electronicadaptation,com-putersoftware,orbysimilarordissimilarmethodologynowknownorhereafterdevelopedisfor-bidden.Theuseinthispublicationoftradenames,trademarks,servicemarks,andsimilarterms,eveniftheyarenotide
5、ntifiedassuch,isnottobetakenasanexpressionofopinionastowhetherornottheyaresubjecttoproprietaryrights.PrintedintheUnitedStatesofAmerica.(MP)987654321springeronline.comPrefaceMonitoringofclinicaltrialsforearlyevidenceofbenefitandharmhas12–4gottenconsiderableattention
6、.Moreformalguidelinesandrequirementshaveevolvedinrecentyears,butinfactmonitoringoftrialsisapracticethat5hasbeengoingonforalmostfourdecades.Fortrialsthatinvolvedconditionsorinterventionswithseriousrisks,suchasmortalityormajormorbidity,thetraditionandpolicyhasbeento
7、haveanindependentmonitoringcommitteetoreviewaccumulatingdataforevidenceofharmorconvincingbenefitthatwouldrequiremodifyingorterminatingatrialearly.Duringthepastfourdecades,manytrialshavehadmonitoringcommitteestoassumethisrespon-sibility.Withthenewemphasisonmonitorin
8、g,thistypeofactivityisincreas-ingdramaticallyasthenumberofclinicaltrialsbeingconductedtoevaluatenewinterventionsforpatientsorparticipantswithseriousrisk
