Interface between Regulation and Statistics in Drug Development


Fundamental Principles of Clinical TrialsINTRODUCTIONGENERAL STATISTICAL CONSIDERATIONSEVOLVING ROLES OF THE STATISTICIAN IN DRUG DEVELOPMENTPOTENTIAL STATISTICAL ISSUES IN REGULATORY REVIEWCONCLUDING REMARKSBIBLIOGRAPHYSelected Statistical Topics of Regulatory ImportanceINTRODUCTIONMULTIPLICITYMultiple EndpointsMultiple Testing Over the Course of the StudyMISSING VALUES AND ESTIMANDSGeneral ConsiderationsMissingness MechanismsApproaches for Missing DataSensitivity AnalysesEstimands and Other Recent Regulatory DevelopmentsConcluding RemarksNON-INFERIORITY STUDYINNOVATIVE TRIAL DESIGNSAdaptive DesignsAdaptive RandomizationSample Size ReestimationSequential DesignsAdaptive Designs for Dose and Treatment SelectionAdaptive Enrichment DesignsMaster ProtocolsBAYESIAN ANALYSIS IN A REGULATORY FRAMEWORKIntroductionPotential Areas of ApplicationRegulatory ConsiderationsChallenges with Bayesian StatisticsConcluding RemarksSURROGATE ENDPOINTS AND BIOMARKERSIntroductionStatistical ConsiderationsRegulatory ConsiderationsConcluding RemarksSUBGROUP ANALYSESBENEFIT-RISK ASSESSMENTIntroductionMethodological Considerations in Benefit-Risk AnalysisRegulatory PerspectivesBenefit-Risk in Health-Technology AssessmentConcluding RemarksBIBLIOGRAPHYStatistical Engagement in Regulatory InteractionsINTRODUCTIONINTERNAL BEHAVIORSDATA MONITORING COMMITTEEREGULATORY MEETINGS AND ADVISORY COMMITTEE MEETINGSSTATISTICAL ROLE IN PROMOTIONAL MATERIAL AND MEDICAL COMMUNICATIONCONCLUDING REMARKSBIBLIOGRAPHYEmerging TopicsTHE USE OF RWE TO SUPPORT LICENSING AND LABEL ENHANCEMENTIntroductionMethodological and Operational ConsiderationsCurrent Regulatory LandscapeConcluding RemarksPATIENT-REPORTED OUTCOMES IN REGULATORY SETTINGSIntroductionDevelopment and Validation of PRO InstrumentsStatistical ConsiderationsRegulatory ConsiderationsConcluding RemarksARTIFICIAL INTELLIGENCE AND MODERN ANALYTICS IN REGULATORY SETTINGSIntroductionAl in Drug DevelopmentRegulatory Experience with Machine Learning and Artificial IntelligenceConcluding RemarksBIBLIOGRAPHY
 
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