Handbook of Statistics in Clinical Oncology

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.

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.