ClinicalTrialDesign:BayesianandFrequentistAdaptiveMethods

Abalancedtreatmentofthetheories,methodologies,anddesignissuesinvolvedinclinicaltrialsusingstatisticalmethodsTherehasbeenenormousinterestanddevelopmentinBayesianadaptivedesigns,especiallyforearlyphasesofclinicaltrials.However,forphaseIIItrials,frequentistmethodsstillplayadominantrolethroughcontrollingtypeIandtypeIIerrorsinthehypothesistestingframework.Frompracticalperspectives,ClinicalTrialDesign:BayesianandFrequentistAdaptiveMethodsprovidescomprehensivecoverageofbothBayesianandfrequentistapproachestoallphasesofclinicaltrialdesign.Beforeunderpinningvariousadaptivemethods,thebookestablishesanoverviewofthefundamentalsofclinicaltrialsaswellasacomparisonofBayesianandfrequentiststatistics.Recognizingthatclinicaltrialdesignisoneofthemostimportantandusefulskillsinthepharmaceuticalindustry,thisbookprovidesdetaileddiscussionsonavarietyofstatisticaldesigns,theirproperties,andoperatingcharacteristicsforphaseI,II,andIIIclinicaltrialsaswellasanintroductiontophaseIVtrials.Manypracticalissuesandchallengesarisinginclinicaltrialsareaddressed.Additionaltopicsofcoverageinclude:Riskandbenefitanalysisfortoxicityandefficacytrade-offsBayesianpredictiveprobabilitytrialmonitoringBayesianadaptiverandomizationLateonsettoxicityandresponseDosefindingindrugcombinationtrialsTargetedtherapydesignsTheauthorutilizescutting-edgeclinicaltrialdesignsandstatisticalmethodsthathavebeenemployedattheworld'sleadingmedicalcentersaswellasinthepharmaceuticalindustry.Thesoftwareusedthroughoutthebookisfreelyavailableonthebook'srelatedwebsite,equippingreaderswiththenecessarytoolsfordesigningclinicaltrials.ClinicalTrialDesignisanexcellentbookforcoursesonthetopicatthegraduatelevel.Thebookalsoservesasavaluablereferenceforstatisticiansandbiostatisticiansinthepharmaceuticalindustryaswellasforresearchersandpractitionerswhodesign,conduct,andmonitorclinicaltrialsintheireverydaywork.