Real-World Evidence in Drug Development and Evaluation

About the author

Harry Yang, Ph.D., is Vice President and Head of Biometrics at Fate Therapeutics. He has 25 years of experience across all aspects of drug research and development, from early target discovery, through pre-clinical, clinical, and CMC programs to regulatory approval and post-approval lifecycle management. He has published 7 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP.
Binbing Yu, Ph.D., is Associate Director in the Oncology Statistical Innovation group at AstraZeneca. He serves as the statistical expert across the whole spectrum of drug R&D, including drug discovery, clinical trials, operation and manufacturing, clinical pharmacology, oncology medical affairs and post-marketing surveillance. He obtained his PhD in Statistics from the George Washington University. His primary research interests are clinical trial design and analysis, cancer epidemiology, causal inference in observation studies, PKPD modeling and Bayesian analysis.

Summary

This book concerns use of real world data (RWD) and real world evidence (RWE) to aid drug development across product cycle. RWD are healthcare data that are collected outside the constraints of conventual controlled randomized trials (CRTs); whereas RWE is the knowledge derived from aggregation and analysis of RWD.

Product details

• Authors: Harry (Medimmune Yang, Harry Yu Yang
• Assisted by: Harry Yang (Editor), Yang Harry (Editor), Binbing Yu (Editor), Yu Binbing (Editor)
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 03.03.2021
• EAN: 9780367026219
• ISBN: 978-0-367-02621-9
• No. of pages: 178
• Series: Chapman & Hall/CRC Biostatistics Series
• Subjects: Natural sciences, medicine, IT, technology > Medicine > General; Medical research, MATHEMATICS / Probability & Statistics / General, SCIENCE / Life Sciences / Biology, MEDICAL / Research, Biology, life sciences, Probability & statistics, Pharmaceutical technology, Probability and statistics, Clinical Trials, Pharmaceutical chemistry and technology, TECHNOLOGY & ENGINEERING / Pharmaceutical