This book is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development.

Wei Zhang is the Vice President, Head of Biometrics at AffaMed Therapeutics, New York.

Fangrong Yan is a Professor of Biostatistics in the School of Science, and Director of Biostatistics and Computational Pharmacy Research Center at China Pharmaceutical University (CPU).

Feng Chen is a Professor of Biostatistics in School of Public Health, Nanjing Medical University (NJMU).

Shein-Chung Chow is currently a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham.

1 Introduction, 2 Complex Innovative Design, 3 Validation Strategy for Biomarker guided Precision/Personalized Medicine, 4 Model-Informed Drug Development, 5 Real-world data and real-world evidence, 6 AI/ML in Medical Research and Drug Development, 7 Challenges in Cancer Clinical Trials, 8 Statistical Methods for Assessment of Biosimilars, 9 Statistical Methods for Assessment of Complex Generic Drugs, 10 Rare Diseases Drug Development