About the Event:
The 21st Century Cures Act established a program to evaluate the potential use of real-world evidence (RWE) to help to support the approval of a new indication for a drug approved and to help to support or satisfy post-approval study requirements. Accordingly, the FDA has been exploring the potential use of Real World Data (RWD) in regulatory decision making. This presentation will start with a general overview of Real-World Data and Real-World Evidence in drug development and an introduction to observational studies and causal inference. Th challenges with RWD/RWE will be discussed from multiple aspects including data quality, study design and statistical methods to adjust potential confounding. At the end of presentation, case studies will be presented.
Speaker: Dr. Joo Yeon Lee
Joo-Yeon Lee, Ph.D. is a senior statistician of Division of Biometrics VII in the Office of Biostatistics in the Center for Drug Evaluation and Research at the FDA. Dr. Lee has involved in FDA-led drug safety studies utilizing sentinel data and other data source such as UK Clinical Practice Research Datalink (CPRD). Dr. Lee has taught the inverse probability weighting method with a case study at causal inference workshop at FDA in November 2017 and short courses at DIA/FDA Biostatistics Industry and Regulator Forum in April 2018 and ASA Biopharmaceutical section regulatory-industry statistics workshop in September 2020.