Clinical trials require strategic thinking and innovative methods since some traditional methods are not adequate for the 21st century.To solve these problems requires good methodological skills, but also an in-depth knowledge of the practical problems we are dealing with and a strategic vision of the pig picture.
"This is the first edition of a comprehensive book covering the most recent methodology on innovative clinical trial designs for drugs and biological products. It is a great reference book for statisticians, clinicians, and other stakeholders involved in drug discovery and development. ...Chang et al aimed to provide the statistical framework to reach the overall development program optimizations in this book. In addition, innovative methodology to mitigate the risks of failed efficacy, safety, strategy, commercial and operation failures have been described by Chang et al. Special techniques such as clinical trial simulations are highly recommended by the authors. ....
In summary, this is an excellent reference book for statisticians, clinicians, and all stakeholders involved in clinical development program with a common goal to reach clinical development optimization.”
—Holly Huang in the Journal of Biopharmaceutical Statistics, October 2019
