Publisher's Synopsis
Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process, Second Edition evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern technologies and novel study designs. The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. More focus on rare diseases and personalized medicines increase the need for more efficient processes. This book focuses on the need to simplify drug development and offers well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. The second edition is completely updated, including new sections on Patient Centricity, Machine Learning, Bayesian Statistics, Disruption in R&D, Wearable technologies, Virtual trials, Real World Evidence, Operational Analytics. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness.
