Phase I trials are the first step in the study of novel therapeutic approaches. They aim to identify the recommended dose, schedule and pharmacologic behavior of new drugs, and to describe the adverse effects of treatment. This practical guide discusses the design, conduct, analysis and ethical aspects of Phase I cancer trials.
This was recommended to me by my boss and mentor, and I’d recommend it to anyone working in oncology research. It goes into detail on models and stats as well as biomarker and PK and results outputs