SpringerBriefsinPharmaceuticalScience&DrugDevelopmentForfurthervolumes:http://www.springer.com/series/10224J.RickTurnerKeyStatisticalConceptsinClinicalTrialsforPharma123J.RickTurner,Ph.D.CardiacSafetyServices,QuintilesEmperorBoulevard4820Durham,NC27703USAe-mail:rick.turner@quintiles.comISSN1864-8118e-ISSN1864-8126ISBN978-1-4614-1661-6e-ISBN978-1-4614-1662-3DOI10.1007/978-1-4614-1662-3SpringerNewYorkDordrechtHeidelbergLondonLibraryofCongressControlNumber:2011938148�TheAuthor(s)2012Allrightsreserved.Thisworkmaynotbetranslatedorcopiedinwholeorinpartwithoutthewrittenpermissionofthepublisher(SpringerScience+BusinessMedia,LLC,233SpringStreet,NewYork,NY10013,USA),exceptforbriefexcerptsinconnectionwithreviewsorscholarlyanalysis.Useinconnectionwithanyformofinformationstorageandretrieval,electronicadaptation,computersoftware,orbysimilarordissimilarmethodologynowknownorhereafterdevelopedisforbidden.Theuseinthispublicationoftradenames,trademarks,servicemarks,andsimilarterms,eveniftheyarenotidentifiedassuch,isnottobetakenasanexpressionofopinionastowhetherornottheyaresubjecttoproprietaryrights.Printedonacid-freepaperSpringerispartofSpringerScience+BusinessMedia(www.springer.com)PrefaceTheultimatepurposeoftheresultsfromaclinicaltrialisnottotelluspreciselywhathappenedinthattrial,but,incombinationwithresultsfromothertrialsinthedrug’sclinicaldevelopmentprogram,togaininsightintolikelydrugresponsesinpatientswhowouldbeprescribedthedrugshoulditbeapprovedformarketing.ThedisciplineofStatisticsenablesustodothis.Thisbookdiscusseskeystatisticalconceptsthatfacilitatetheanalysisofdatacollectedfromagroupofindividualsparticipatinginabiopharmaceuticalclinicaltrial,theestimationoftheirclinicalsignificanceinthegeneralpopulationofindividualslikelytobeprescribedthedrugifapproved,andtherelateddecisionmakingthatoccursatboththepublichealthlevel(byregulatoryagencieswhendecidingwhetherornottoapproveanewdrugformarketing)andtheindividualpatientlevel(byphysiciansandtheirpatientswhendecidingwhetherornotth...
