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.
