Handbook of Statistics in Clinical Oncology

Antje Hoering is the President and CEO of Cancer Research And Biostatistics (CRAB) and leads a team of approximately eighty talented and dedicated oncology research professionals, all united in our mission to help conquer cancer. She also serves as the lead statistician of the SWOG Myeloma Committee and holds affiliate appointments at the University of Washington Biostatistics department and the Fred Hutch Cancer Center.Megan Othus is a Professor of Biostatistics at the Fred Hutchinson Cancer. She serves as the lead statistician of the SWOG Leukemia and Rare Cancer Committees. Her research interests focus on the design and endpoints in oncology clinical trials.John Crowley received his master’s and doctorate degrees (in 1970 and 1973, respectively) in Biomathematics from the University of Washington, and was the Director of the SWOG Statistical Center from 1984 to 2012. In 1997 Dr. Crowley founded Cancer Research And Biostatistics (CRAB), was the President and CEO of CRAB until 2014, and currently serves as the Chief of Strategic Alliances. Dr. Crowley's research interests focus on the design and analysis of cancer clinical and translation trials.

• SECTION 1 Cancer Prevention & ScreeningChapter 1 Cancer Screening TrialsChapter 2 Cancer Risk Prediction ModelsChapter 3 Incorporating External Registry Data Into Cohort-based Cancer Risk Prediction ToolsSECTION 2 Trial Design | Early-Phase TrialsChapter 4 Phase I – Overview and Recent Trial DesignsChapter 5 Statistical and Machine Learning Methods for Phase I Dose-FindingChapter 6 Seamless Phase I/II Trial Design for Assessing Toxicity and Efficacy for Targeted AgentsChapter 7 Designs Using Time to Event Endpoints / Single Arm versus Randomized Phase II DesignsChapter 8 Phase II Selection DesignsChapter 9 Phase II Trials with Multiple StrataSECTION 3 Trial Design | Late-Phase TrialsChapter 10 Cure Rate Survival ModelsChapter 11 Phase III Trials for Targeted AgentsChapter 12 Phase II and III Clinical Trial Designs for Precision MedicineChapter 13 SMARTs in OncologyChapter 14 Statistical Considerations in the Design and Analysis of Cancer Trials with Immune-Oncology TherapiesChapter 15 Alpha SplittingChapter 16 Early Stopping of Clinical Trials Evaluating Targeted TherapiesChapter 17 Noninferiority TrialsChapter 18 Considerations for Pediatric Oncology TrialsSECTION 4 Trial ConductChapter 19 An Overview of Master ProtocolsChapter 20 On Use of Covariates in Randomization and Analysis of Clinical TrialsChapter 21 Pragmatic Clinical Trials in Clinical Oncology: A Statistical PerspectiveChapter 22 Dynamic Treatment Regimens and Sequential Multiple Assignment Randomized Trial in Cancer ResearchChapter 23 Outcome-Adaptive RandomizationChapter 24 Current Suggested Practices and Issues for Data and Safety Monitoring Committees in Cancer Clinical TrialsChapter 25 Improving Data Collection: EHR-to-EDC Assisted Data TransferChapter 26 Barriers and Disparities in Access to Cancer Clinical Trials – Causes and Implications Chapter 27 SWOG Statistical Calculators for Design and Analysis of Clinical TrialsChapter 28 Streamlining Data Collection and Trial ConductSECTION 5 Beyond the Primary EndpointChapter 29 Use of Circulating Tumor DNA in Oncology – ctMoniTRChapter 30 Statistical Analysis of -Omics DataChapter 31 Principles of Design and Analysis for Patient-Reported OutcomesChapter 32 X Intermediate and Surrogate Endpoints in Phase III RandomizedChapter 33 Prognostic Groups via Interpretable Function Approximation: Tree-based and Extreme Regression Models