Handbook of Statistics in Clinical Oncology

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Antje Hoering (Fred Hutchinson Cancer Research Center, USA) Megan Othus (Fred Hutchinson Cancer Center, USA)

Handbook of Statistics in Clinical Oncology

Antje Hoering (Fred Hutchinson Cancer Research Center, USA), Megan Othus (Fred Hutchinson Cancer Center, USA), John Crowley (Cancer Research and Biostatistics, Seattle, Washington, USA)

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Hardback

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English

Chapman & Hall/CRC
31 December 2025

Clinical trials; Oncology; Probability & statistics; Biology, life sciences; Pharmaceutical technology

Since the third edition of this handbook, significant advances have transformed the field of oncology. Most cancer types now offer multiple treatment options, with immunotherapies and targeted therapies becoming the standard of care. Master protocols, which allow the addition of new treatment arms without requiring new protocols, have gained popularity—not only to expedite the approval process for new therapies but also to ensure that patients receive the most beneficial treatments tailored to their individual needs. This revised edition features contributions from leading cancer trial statisticians, providing expert insights into modern oncology trial design and methodology. The handbook is structured into five key parts:

Part 1: Cancer prevention and screening trial designs, including risk prediction models and prevention trials Part 2: Early-phase trial designs, covering dose-finding studies, selection designs, and multi-strata trials Part 3: Late-stage trial designs, including approaches for IO therapies, cure-rate models, targeted agents, and considerations for pediatric oncology trials Part 4: Trial conduct and operations, addressing best practices for Data Monitoring Committees (DMCs), SWOG/CRAB calculators, pragmatic trials, and clinical trial innovation Part 5: Beyond primary endpoints, exploring surrogate endpoints, microbiome research, patient-reported outcomes (PROs), and tree-based partitioning methods

This updated edition provides a comprehensive resource for researchers, clinicians, and statisticians involved in the evolving landscape of oncology clinical trials.

Edited by: Antje Hoering (Fred Hutchinson Cancer Research Center USA), Megan Othus (Fred Hutchinson Cancer Center, USA), John Crowley (Cancer Research and Biostatistics, Seattle, Washington, USA)
Imprint: Chapman & Hall/CRC
Country of Publication: United Kingdom
Edition: 4th edition
Dimensions: Height: 254mm, Width: 178mm,
ISBN: 9781032596952
ISBN 10: 1032596953
Pages: 526
Publication Date: 31 December 2025
Audience: Professional and scholarly , College/higher education , Undergraduate , Further / Higher Education
Format: Hardback
Publisher's Status: Forthcoming

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

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.