In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies and embed quality of life objectives. Reflecting this, Susan Halabi, PhD and Stefan Michiels, PhD edited “A Textbook of Clinical Trials in Oncology: A Statistical Perspective” with the goal to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. This book is intended for statisticians and investigators with minimal clinical trial experience, and it will serves as a guide with case studies which give the work a "hands-on" approach and real examples of flaws in previously reported clinical trials and how to avoid them.
Historically, clinical trials in cancer with cytotoxic agents were conducted sequentially, starting with a phase I trial and advancing to phase II and phase III trials. The advancement in genetic and molecular technologies, however, has challenged this paradigm and as efficient designs, ranging from seamless phase II/III trials to adaptive studies, which have permeated the field. Basket and umbrella trials have also evolved so that trials are conducted efficiently across genetic variants or cancer histologies.
Advances in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology by Internationally recognized statisticians from academia and pharmaceutical companies. Also included in the book are topics such as innovative phase I and II designs, adaptive and biomarker-driven trials, dynamic treatment regimens, designs of trials in immune-oncology and rare diseases, subgroup analysis and developing and validating prognostic models and signatures.
This book is published by Chapman & Hall/CRC and is available as eBook.