Fundamental Concepts for New Clinical Trialists

This text describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. It offers first-hand perspectives on real-world issues, such as common and challenging clinical trial designs and the proper reporting of clinical trial results in the medical literature. Drawing on their experiences in academia and industry, the authors provide a foundation for understanding the fundamental concepts necessary for working in clinical trials.