Controversial Statistical Issues in Clinical Trials

"... it is very valuable that the book calls the reader's attention to the numerous problems which are relevant every day and I recommend to make this book available to personnel in all biometrical university departments, CROs and operating departments in the pharmaceutical industry to enable them to cope with the most important controversial aspects in planning and execution of clinical studies."
-Rainer Muche, ISCB News, December 2013

"This volume deals with an important area-issues in clinical trials research which are perhaps not fully resolved. ... it is wide ranging, covering all aspects of clinical trials, and has excellent links and references to regulatory aspects. It will therefore provide a useful reference work for clinical trials researchers."
-David J. Hand, International Statistical Review, 2012

"I would recommend this book since it covers a number of areas that have not been covered in as much detail elsewhere. In particular, I thought the chapters on molecularly targeted therapies, follow-on biologics, multiregional clinical trials and good statistical practices were well written and useful."
-William Mietlowski, Journal of Biopharmaceutical Statistics, Issue 5, 2012

"Written by one of the preeminent experts in the field, this book provides a useful desk reference and state-of-the art examination of problematic issues in clinical trials for scientists in the pharmaceutical industry, medical/statistical reviewers in government regulatory agencies, and researchers and students in academia."
-Zentralblatt MATH