Interface between Regulation and Statistics in Drug Development

This book provides a comprehensive and accessible overview of the interplay between statistics and drug development,with a focus on emerging themes and challenges in the field. It is designed to be a valuable resource for statisticians, medical researchers, and regulatory personnel, as well as graduate students in the health sciences.

Format: Paperback / softback
Length: 146 pages
Publication date: 01 August 2022
Publisher: Taylor & Francis Ltd

The significance of statistics in the design, execution, analysis, and reporting of clinical trials or observational studies aimed at regulatory purposes cannot be overstated. As a result, regulatory authorities worldwide have issued numerous guidelines that specifically address statistical issues related to drug development. However, the available literature on this crucial topic is somewhat sporadic and often not readily accessible to drug developers and regulatory personnel. This book aims to bridge this gap by providing a comprehensive and systematic exposition of the interplay between statistics and drug development.

Throughout the drug development continuum, regulatory and statistical interactions are of paramount importance. The role of the statistician becomes particularly crucial in navigating the evolving regulatory and healthcare landscapes. This book delves into the various statistical challenges that arise during drug development and highlights the significance of effective communication and collaboration between statisticians and other stakeholders.

One of the key themes explored in this book is the importance of statistical methodology in drug development. The authors discuss the various statistical techniques and approaches used in clinical trials and observational studies, including hypothesis testing, sample size determination, and data analysis. They also address the challenges associated with these methodologies, such as selecting appropriate statistical models, addressing confounding factors, and interpreting results.

Another important aspect of this book is the consideration of emerging trends in drug development. The authors highlight the growing emphasis on personalized medicine, the use of real-world data, and the development of novel drug delivery systems. They discuss the challenges and opportunities associated with these trends, including the need for robust statistical methodologies, the integration of diverse data sources, and the development of regulatory frameworks that support innovation.

The book is designed to be accessible to readers with an intermediate knowledge of statistics, making it a valuable resource for statisticians, medical researchers, regulatory personnel, and graduate students in the health sciences. The authors, with their extensive experience in the pharmaceutical industry and academia, as well as their extensive regulatory experience, bring a wealth of knowledge and insights to the many examples and case studies presented throughout the book.

In conclusion, the significance of statistics in drug development cannot be overstated. This book provides a comprehensive and systematic exposition of the interplay between statistics and drug development, offering valuable insights to a wide range of stakeholders. By addressing the challenges and opportunities in this field, the book contributes to the acceleration of the development of pharmaceutical medicines that serve patients with unmet needs.

Weight: 320g
Dimension: 234 x 156 (mm)
ISBN-13: 9780367608286