Deepak Khatry, Ph.D., a Westat Associate Director and a clinical trials biostatistician, has written Evidence Derived from Real-World Data (RWD): Utility, Constraints, and Cautions, the second chapter in a new book: Real-World Evidence in Drug Development and Evaluation, published in 2021 under the Biostatistics Series of Chapman & Hall/CRC Press.

Dr. Khatry addresses

• What RWD is in the context of drug development and clinical practice
• Why RWD is important
• How RWD can be useful
• Study designs and statistical methods necessary to ensure high-quality real-world evidence (RWE)

He concludes with actual biopharmaceutical examples and a summary of findings. He also provides cautions and recommendations to researchers and practitioners on the generation and use of real-world evidence.

Written for pharmaceutical industry and clinical practitioners by experienced researchers in the pharmaceutical industry, the book is a single and comprehensive resource to learn about RWE, an emerging and important area of research and application at the forefront of pharmaceutical innovations. The book contains a wide range of real-world evidence examples with applications throughout the lifecycle of drug product development and evidence evaluation.