Interface between Regulation and Statistics in Drug Development

With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs.

• Regulatory and statistical interactions throughout the drug development continuum
• The critical role of the statistician in relation to the changing regulatory and healthcare landscapes
• Statistical issues that commonly arise in the cours