This book on improving the efficiency of clinical development was published by John Wiley & Sons and has been included in the Journal for Clinical Studies Library and The First Clinical Research Bookshelf.
“Dr Rosenberg’s new book The Agile Approach to Adaptive Research first outlines the current state of the pharmaceutical and biotechnology industries, where considerably increased research and development expenditures have not led to a greater number of investigational drugs reaching marketing approval. He then captures the current excitement surrounding adaptive clinical research (also called adaptive design), and provides a very readable introduction to the methodologies involved in implementing such research.” Journal for Clinical Studies March 2010
“The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development” presents adaptive methods of clinical research from three welcome perspectives. First, it discusses the use of adaptive methods in protocol design: dose-ranging, randomization, treatment switching, etc. Second, it expands adaptive concepts to study operations. Third, it explains how to obtain the real-time information needed to adapt with agility. Unlike other volumes that focus on the statistics of protocol design, this book includes almost no formulae and takes a much broader perspective. As a result, it is ideal for senior executives who want a strategic view of adaptive methods, managers looking for practical opportunities to significantly improve the efficiency of their operations, and statisticians interested in learning the broader ramifications of their arcane expertise.” Journal of Clinical Research Best Practices April 2010