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Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details
Session Chair(s)
Yaping Wang, PhD
Mathematical Statistician, OB, OTS, CDER
FDA, United States
Real world data (RWD) are data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources such as electronic health records (EHRs), claims and billing activities, product and disease registries, et al. The RWD is considered as a promising data source that can help fill the gaps of current expensive yet suboptimal clinical trial enterprise. The FDA and EMA have released multiple guidance documents on the usage of real world evidence (RWE). In this session, experts from regulatory agencies (CDER and CDRH) and pharmaceutical industry who work with real clinical trials incorporating real world data will share their experiences and provide insight into implementing trials with RWD/RWE.
Learning Objective : Describe the regulatory context of the real world data (RWD) and real world evidence (RWE) in evaluating medical products, and learn how to apply it from the industry point of view; Discuss the state of statistical science in using RWD/RWE to support label expansion for medical products on the market and to inform clinical study design and analysis for marketing applications.
Speaker(s)
Points to Consider in Evaluating Real-world Data
Thomas E. Gwise, PhD
FDA, United States
Division Director, Division of Biometrics IX, OTS, CDER
State of Science in Statistics to Generate Real World Evidence from Real World Data for Regulatory Considerations
Martin Ho, PhD, MS
Google, United States
Head of Biostatistics
Utilizing Real World Evidence with Clinical Trials
Thomas Jemielita, PhD, MS
Merck & Co., Inc., United States
Senior Scientist, Biostatistics
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