StatisticsinClinicalVaccineTrials•JozefNautaStatisticsinClinicalVaccineTrials123JozefNautaSolvayPharmaceuticalsGlobalStatisticsC.J.vanHoutenlaan361381CPWeespNetherlandsj.nautaekimp@worldonline.nlISBN978-3-642-14690-9e-ISBN978-3-642-14691-6DOI10.1007/978-3-642-14691-6SpringerHeidelbergDordrechtLondonNewYorkcThisworkissubjecttocopyright.Allrightsarereserved,whetherthewholeorpartofthematerialisconcerned,specificallytherightsoftranslation,reprinting,reuseofillustrations,recitation,broadcasting,reproductiononmicrofilmorinanyotherway,andstorageindatabanks.DuplicationofthispublicationorpartsthereofispermittedonlyundertheprovisionsoftheGermanCopyrightLawofSeptember9,1965,initscurrentversion,andpermissionforusemustalwaysbeobtainedfromSpringer.ViolationsareliabletoprosecutionundertheGermanCopyrightLaw.Theuseofgeneraldescriptivenames,registerednames,trademarks,etc.inthispublicationdoesnotimply,evenintheabsenceofaspecificstatement,thatsuchnamesareexemptfromtherelevantprotectivelawsandregulationsandthereforefreeforgeneraluse.Coverdesign:WMXDesignGmbH,HeidelbergPrintedonacid-freepaperSpringerispartofSpringerScience+BusinessMedia(www.springer.com)LibraryofCongressControlNumber:2010937985⃝Springer-VerlagBerlinHeidelberg2011TomywifeErnaKimp,andoursonIzaak.•PrefaceThisbookisintendedforstatisticiansworkinginclinicalvaccinedevelopmentinthepharmaceuticalindustry,atuniversities,atnationalvaccinesinstitutes,etc.Statisti-ciansalreadyinvolvedinclinicalvaccinetrialsmayfindsomeinterestingnewideasinit,whilecolleagueswhoarenewtovaccineswillbeabletofamiliarizethem-selvesquicklywiththestatisticalmethodology.Agoodknowledgeofstatisticsisassumed.Thereadershouldbefamiliarwithhypothesistesting,pointandconfidenceintervalestimation,likelihoodmethods,regression,mathematicalandstatisticalnotation,etc.Abookthatwouldprovidethenecessarybackgroundis:ArmitageP.,BerryG.andMatthewsJ.N.S.StatisticalMethodsinMedicalResearch,4thedition,BlackwellScience,NewYork,2001.Thescopeofthebookispracticalratherthantheore...
