Principles of Clinical Cancer Research

This book on principles of clinical cancer research is primarily for trainees and junior faculty interested in careers in clinical and translational research. It has three principal aims. The first is to introduce readers to the fundamentals of clinical cancer research, including the basic methodologies used in the field. The second is to guide trainees who aspire to careers in this field, by offering a mix of practical advice and analytical tools, and references to resources. The third is to assist educators, by providing them with an organizational structure and a set of practical examples upon which they can build an effective curriculum. The book is organized into 5 parts comprising 29 chapters. Within each chapter, the book attempts to provide a basic theoretical framework and heuristic explanation, coupled with a moderate degree of technicality and real-world examples. The first phase of this book is dedicated to translational research, including principles of molecular and cell biology, mechanisms of tumor growth, therapeutic strategies, and preclinical research methods. It discusses biomarker development and collaborations with industry as a segue into clinical applications. The second phase of this book focuses on fundamentals of human subjects research, including basic study designs and statistical methods. It introduces more sophisticated methods such as generalized linear modeling, time-to-event analysis, and machine learning, as well as introductions to critical branches of the population sciences, including cancer epidemiology, disparities research, and cost-effectiveness analysis. The final phase of the book deals with prospective human subjects research (i.e., clinical trials), including classic early and late phase trial designs, innovative adaptive trial designs, and meta-analysis. Special applications in the context of imaging, screening and prevention, quality of life, and comparative effectiveness research are also considered, to round out the volume.