Clinical Trials in Oncology (Hardcover, 3)

IntroductionA Brief History of Clinical TrialsThe Southwest Oncology Group (SWOG)The Reason for This BookStatistical ConceptsIntroductionThe Single-Arm Phase II Trial?EstimationThe Randomized Phase III Trial?Hypothesis TestingThe Proportional Hazards ModelSample Size CalculationsConcluding RemarksThe Design of Clinical TrialsObjectivesEligibilityTreatment ArmsRandomized Treatment AssignmentEndpointsDifferences to be Detected or Precision of Estimates and Other AssumptionsUse of Independent Data Monitoring CommitteesEthical ConsiderationsConclusionPhase I and Phase I/II TrialsPhase I TrialsPhase I/II DesignsPhase II TrialsSingle-Arm Phase II DesignsMulti-Arm Phase II TrialsOther Phase II Designs Randomized versus Single-Arm: The Pros and ConsConclusion Phase III Trials RandomizationOther Design ConsiderationsEquivalence or Noninferiority Trials Designs for Targeted AgentsMulti-Arm TrialsInterim AnalysesPhase II/III TrialsConcluding RemarkData Management and Quality ControlIntroduction: Why Worry?Protocol DevelopmentData CollectionData SubmissionData EvaluationPublicationQuality Assurance AuditsTrainingDatabase ManagementConclusionReporting of Results Timing of ReportRequired Information AnalysesConclusion PitfallsIntroductionHistorical ControlsCompeting RisksOutcome by Outcome AnalysesSubset AnalysesSurrogate EndpointsExploratory AnalysesIntroductionSome Background and Notation Identification of Prognostic FactorsForming Prognostic GroupsAnalysis of Microarray DataMeta-AnalysisConcluding RemarksSummary and ConclusionsReferencesIndex