Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development
This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials.
Preceded by Phase I cancer clinical trials: a practical guide / Elizabeth A. Eisenhauer, Christopher Twelves, Marc Buyse. 1st ed. 2006.
NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing--including genomics-based "basket" trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters ...
The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research.
These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost.
Along with relevant references, the book highlights current regulatory views. The book covers all aspects of cancer clinical trial starting from early phase development.
Guidance for industry. Good pharmacovigilance practices and pharmacoepidemiologic assessment; March 2005 (20 pp.). 1Kotterman MA, Schaffer DV. Engineering adeno-associated viruses for clinical gene CLINICAL TRIALS 568 25.
The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials.
This book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials.
BOX 5 Lung Cancer Master Protocol Trial Mary Redman, associate member of the Clinical Research Division at the Fred Hutchinson ... the Foundation for the National Institutes of Health (FNIH), a number of patient advocacy organizations, ...