Colin G. Miller • Joel Krasnow
Lawrence H. Schwartz
Editors

2014

There are a number of books written about clinical trials [1–5]. They take a biostatistical approach providing generic information about how imaging can be used as clinical endpoints or biomarkers. This book is written specifically to address the questions around the application of medical imaging in the complex and highly regulated environment of clinical trials. It has also been timed to coincide with a new set of guidelines issued by the US Food and Drug Administration (FDA) entitled “Guidance on Standards for Clinical Trial Imaging Endpoints” which we have included verbatim, with permission, as Appendix 1 . Medical imaging has made dramatic advances in the last 30 or 40 years with the advent of higher computing power and new technologies. The magnitude of data that clinical trialists and radiologists have to manage has grown exponentially as have the skills required to accurately evaluate and interpret these images.