This second edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. This edition significantly updates the chapters on p

"Those familiar with the first edition will find substantial updates as well as five entirely new chapters … The scope is wide-ranging …"
—ISCB News, 59, June 2015

"In this second edition, the authors update two chapters on protocol amendment and clinical trial simulation to reflect new developments after the first edition and add five new chapters. … It also provides many useful algorithms for various designs and SAS code throughout the book. … this is an excellent book with wonderful resources on adaptive design methods in clinical trials. It will be very useful to graduate students in the areas of clinical development and biostatistics looking for an advanced textbook on this topic. The book is very well written and a joy to read. I think it would be a critical addition to the bookshelf for statisticians involved in adaptive design and analysis in clinical trials."
—Hongfei Guo, Journal of the American Statistical Association, December 2013

"This second edition remains a useful reference source for anyone interested in advancing innovative trial designs and wishing to incorporate adaptations, modifications, and changes to the drug development process. Five new chapters have been added and are all worth reading; bringing the technical material covered up-to-date. For anyone working in, and studying, clinical research the book is worth purchasing and will make a valuable addition to any library. … this revision continues to provide a balanced summary of statistical methods, together with the authors’ perspective on current regulatory practice."
—International Statistical Review, 80, 2012

Praise for the First Edition
The authors are to be commended for the endeavour to provide a monograph about this rapidly evolving area in- to our knowledge- the first book specifically devoted to adaptive design methods . . . we think it provides a valuable contribution to the area of adaptive design.
—Frank Miller and Stig Johan Wiklund, AstraZeneca, Statistical Medicine, 2008, Vol. 27

In summary, this is an extremely useful book for clinical trials statisticians wishing to stay abreast with the innovative approaches that are being developed amid some controversies regarding their benefits.
—Yuko Palesch, Medical University of South Carolina, Journal of the American Statistical Association, March 2008, Vol. 103, No. 481

…This book is one of the first of its kind to be released solely dealing with adaptive designs in clinical trials. … a useful reference for those who have a mathematical background and wish to understand some of the adaptive design methodologies. …With the ever-increasing need for adaptive trials, we could see this book having a large influence …
—Pharmaceutical Statistics, 2008

…a useful reference source for anyone interested in advancing innovative trial designs and wishing to incorporate adaptations, modifications, and changes to the drug, device, and biological developmental processes.
—C.M. O’Brien, International Statistical Review, Vol. 75, No. 2, 2007

…uses a broad definition of adaptive design methods… .This breadth of coverage is to be commended and makes the book a useful reference and overview for anyone who is starting to explore this area … the book is worth reading.
—Angela Wade, University College London, UK

The book covers a vast area. To my knowledge this book is the first attempt to provide a concise description of various methodologies in a highly dynamic area. The authors deserve to be praised for bringing this huge range of approaches, including very recent trends, together in one book … .
—Tim Friede, University of Warwick, Biometrics, March 2008

"Those familiar with the first edition will find substantial updates as well as five entirely new chapters … The scope is wide-ranging …"
—ISCB News, 59, June 2015

"In this second edition, the authors update two chapters on protocol amendment and clinical trial simulation to reflect new developments after the first edition and add five new chapters. … It also provides many useful algorithms for various designs and SAS code throughout the book. … this is an excellent book with wonderful resources on adaptive design methods in clinical trials. It will be very useful to graduate students in the areas of clinical development and biostatistics looking for an advanced textbook on this topic. The book is very well written and a joy to read. I think it would be a critical addition to the bookshelf for statisticians involved in adaptive design and analysis in clinical trials."
—Hongfei Guo, Journal of the American Statistical Association, December 2013

"This second edition remains a useful reference source for anyone interested in advancing innovative trial designs and wishing to incorporate adaptations, modifications, and changes to the drug development process. Five new chapters have been added and are all worth reading; bringing the technical material covered up-to-date. For anyone working in, and studying, clinical research the book is worth purchasing and will make a valuable addition to any library. … this revision continues to provide a balanced summary of statistical methods, together with the authors’ perspective on current regulatory practice."
—International Statistical Review, 80, 2012

Praise for the First Edition
The authors are to be commended for the endeavour to provide a monograph about this rapidly evolving area in- to our knowledge- the first book specifically devoted to adaptive design methods . . . we think it provides a valuable contribution to the area of adaptive design.
—Frank Miller and Stig Johan Wiklund, AstraZeneca, Statistical Medicine, 2008, Vol. 27

In summary, this is an extremely useful book for clinical trials statisticians wishing to stay abreast with the innovative approaches that are being developed amid some controversies regarding their benefits.
—Yuko Palesch, Medical University of South Carolina, Journal of the American Statistical Association, March 2008, Vol. 103, No. 481

…This book is one of the first of its kind to be released solely dealing with adaptive designs in clinical trials. … a useful reference for those who have a mathematical background and wish to understand some of the adaptive design methodologies. …With the ever-increasing need for adaptive trials, we could see this book having a large influence …
—Pharmaceutical Statistics, 2008

…a useful reference source for anyone interested in advancing innovative trial designs and wishing to incorporate adaptations, modifications, and changes to the drug, device, and biological developmental processes.
—C.M. O’Brien, International Statistical Review, Vol. 75, No. 2, 2007

…uses a broad definition of adaptive design methods… .This breadth of coverage is to be commended and makes the book a useful reference and overview for anyone who is starting to explore this area … the book is worth reading.
—Angela Wade, University College London, UK

The book covers a vast area. To my knowledge this book is the first attempt to provide a concise description of various methodologies in a highly dynamic area. The authors deserve to be praised for bringing this huge range of approaches, including very recent trends, together in one book … .
—Tim Friede, University of Warwick, Biometrics, March 2008

Shein-Chung Chow is a professor in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. Dr. Chow is also an adjunct professor of clinical sciences at Duke–National University of Singapore Graduate Medical School and the editor-in-chief of the Journal of Biopharmaceutical Statistics. He has authored or co-authored numerous papers and books, including the Handbook of Adaptive Designs in Pharmaceutical and Clinical Development and Controversial Statistical Issues in Clinical Trials.

Mark Chang is the executive director of biostatistics and data management at AMAG Pharmaceuticals and an adjunct professor at Boston University. A fellow of the American Statistical Association, Dr. Chang is a co-founder of the International Society for Biopharmaceutical Statistics and serves on the editorial boards of two statistical journals. He has authored many publications, including Adaptive Design Theory and Implementation Using SAS and R and Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies.