"It stands ready to satisfy the appetite of any pharmaceutical scientist with a respectable statistical appetite." (Journal of Clinical Research, June 2008)

"Biostatisticians, applied statisticians, and clinical scientists will find this book very valuable, and it is suitable for a graduate level clinical trial course." (Journal of Statistical Computation and Simulation, September 2005)

"…a comprehensive introduction…highly recommended…" (Statistical Methods in Medical Research, Vol. 14, 2005)

"…I will find this book a handy resource for future consulting with medical researchers." (Journal of the American Statistical Association, June 2005)

"…the authors have done a commendable job of blending large amounts of statistical and regulatory information in a way that is easy to comprehend and directly applicable…" (Clinical Chemistry, April 2005)

"…provides a comprehensive overview of the rather general area of clinical trials…an essential reference text." (Journal of Applied Statistics, Vol.32, No.3, April 2005)

"Numerous real-life examples and illustrations form clinical case studies are included…" (Zentralblatt Math, Vol.1050, 2005)

"…certainly comprehensive...should be a standard reference for both clinical scientists and biostatisticians…" (Technometrics, February 2005)