Clinical Trials in Oncology, Third Edition

The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.

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

Stephanie Green, Jacqueline Benedetti