Antje Hoering - Böcker

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 trialsPart 2: Early-phase trial designs, covering dose-finding studies, selection designs, and multi-strata trialsPart 3: Late-stage trial designs, including approaches for IO therapies, cure-rate models, targeted agents, and considerations for pediatric oncology trialsPart 4: Trial conduct and operations, addressing best practices for Data Monitoring Committees (DMCs), SWOG/CRAB calculators, pragmatic trials, and clinical trial innovationPart 5: Beyond primary endpoints, exploring surrogate endpoints, microbiome research, patient-reported outcomes (PROs), and tree-based partitioning methodsThis updated edition provides a comprehensive resource for researchers, clinicians, and statisticians involved in the evolving landscape of oncology clinical trials.

Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging techniques have become common practice, and statistical methods on how to analyse such data have been refined in this area. A compilation of statistical topics relevant to these new advances in cancer research, this third edition of Handbook of Statistics in Clinical Oncology focuses on the design and analysis of oncology clinical trials and translational research. Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials, incorporating updates to all four parts: Phase I trials: Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches, along with new chapters on phase 0 trials and phase I trial design for targeted agents.Phase II trials: Updates to current experience in single-arm and randomized phase II trial designs. New chapters include phase II designs with multiple strata and phase II/III designs.Phase III trials: Many new chapters include interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials.Exploratory and high-dimensional data analyses: All chapters in this part have been thoroughly updated since the last edition. New chapters address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added.Accessible to statisticians and oncologists interested in clinical trial methodology, the book is a single-source collection of up-to-date statistical approaches to research in clinical oncology.