ABSTRACT
Use of real-world data (RWD) and real-world evidence (RWE) are increasingly recognized as important for synthesizing relevant information to aid clinical decision-making, and for advancing healthcare. Acceleration in the use of RWD and RWE is expected to continue with newer developments in technology and advancements in computer-aided analytics. This chapter integrates some key sections to provide a state-of-the-art summary and synthesis of the latest thinking on the topic with potential practical implications for clinical research and development: (1) What is RWD in the context of drug development and clinical practice? (2) Why is RWD important? (3) For what purposes can RWD be useful? (4) What study designs and statistical methods will be necessary to ensure high quality RWE? The chapter concludes with application examples from the biopharmaceutical real world, a summary of the main findings, and cautions and recommendations to researchers and practitioners interested in conducting real-world studies to generate and use real-world evidence.
