StatisticalMonitoringofClinicalTrialsLemuelA.MoyéStatisticalMonitoringofClinicalTrialsFundamentalsforInvestigatorsWith69FiguresLemuelA.MoyéUniversityofTexasHealthScienceCenteratHoustonSchoolofPublicHealthHouston,TX77030USAmoyelaptop@msn.comLibraryofCongressControlNumber:2005931408ISBN-10:0-387-27781-1e-ISBN0-387-27782-XISBN-13:978-0387-277813Printedonacid-freepaper.©2006SpringerScience+BusinessMedia,Inc.Allrightsreserved.Thisworkmaynotbetranslatedorcopiedinwholeorinpartwithoutthewrittenpermissionofthepublisher(SpringerScience+BusinessMedia,Inc.,233SpringStreet,NewYork,NY10013,USA),exceptforbriefexcerptsinconnectionwithreviewsorscholarlyanalysis.Useinconnec-tionwithanyformofinformationstorageandretrieval,electronicadaptation,computersoftware,orbysimilarordissimilarmethodologynowknoworhereafterdevelopedisforbidden.Theuseinthispublicationoftradenames,trademarks,servicemarksandsimilarterms,eveniftheyarenotidentifiedassuch,isnottobetakenasanexpressionofopinionastowhetherornottheyaresubjecttoproprietaryrights.PrintedintheUnitedStatesofAmerica.(MVY)987654321springeronline.comToDixieandtheDELTsviiPrefaceAprefaceisanopportunityforyouandmetoshareanamiableconversationbeforetheseriousworkstarts.Ifyougivemeamoment,Iwillsharewithyoumymotiva-tionsforwritinganintroductorytextaboutthestatisticalmonitoringofclinicaltrials,astapleofmodernresearcheffortsinheatlhcare.Iampleasedtohavebeeninvolvedinclinicalresearchforeighteenyears.ManyofmyeffortsfocusedonpreparationsforandpresentationstoDataMonitor-ingCommittees(DMCs),eachofwhichwastaskedwithoverseeingtheconductofaparticularclinicalstudy.Duringtheseactivities,Ihavespokenwithmanyclini-ciansabouttheepidemiologyandbiostatisticalfoundationofthismodeofclinicalresearch.Inmyexperience,nothingconfusesaDMCmemberasdotheseso-called“stoppingrules”formonitoringtheconductofahealthcareresearchstudy.Theideaofprematurelyendingastudymakesintuitivesensetotheclinicalmembersofthecommittee.Therulesthemselveswiththeirarcaneterminologyaretheproblem.Descr...
