This book describes statistical techniques for the design and evaluation of research studies on medical diagnostic tests, screening tests, biomarkers and new technologies for classification and prediction in medicine.Readership: Researchers and students in biostatistics (medical statistics), statistics, medical science, public health and clinical research.

"Statistical results are given a methodical treatment. In each chapter statistical results are motivated, stated and usually proven, and then illustrated on a variety of datasets based on actual trials. Many of the results were developed by Pepe and her colleagues, who have advanced the field in seminal ways. Chapters end with a concluding remarks section, a set of exercises, and proofs of more involved theoretical results, when needed. Concluding remarks sections nicely summarize results and discuss open research questions. References to key papers are given throughout. This structure allows the book to serve as both a classroom text and an excellent reference to the current literature." - Journal of Biopharmaceutical Studies

"I very much recommend this book to a range of audiences, from those wanting an introduction to diagnostic test concepts and methods to active researchers in the area. This book is likely to stimulate considerable progress in development of new statistical methods for diagnostic tests, an area that relative to therapeutics has received little attention from biostatisticians." - Journal of Biopharmaceutical Studies