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Thursday, June 18 • 9:30am - 10:30am
#415 SL: Opportunities and Challenges for Real World Data and Real World Evidence: Dive Into the Details

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-729-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Yaping Wang, PhD

Speaker

Points to Consider in Evaluating Real-world Data
Thomas E. Gwise, PhD

State of Science in Statistics to Generate Real World Evidence from Real World Data for Regulatory Considerations
Martin Ho, MS

Utilizing Real World Evidence with Clinical Trials
Thomas Jemielita, PhD, MS


Speakers
avatar for Martin Ho

Martin Ho

Associate Director, Office of Biostatistics and Epidemiology, CBER, FDA
Mr. Martin Ho is Associate Director of Quantitative Patient Inputs & Real-World Patient Evidence at Office of Biostatistics & Epidemiology, CBER, US FDA. Prior, he was the Director of Quantitative Innovation at Center for Devices, turning new data sources into regulatory-grade evidence... Read More →
avatar for Thomas Jemielita

Thomas Jemielita

Senior Scientist, Biostatistics, Merck & Co., Inc.
Thomas Jemielita is a senior scientist in Early Development Statistics (EDS) within BARDS at Merck & Co., Inc., currently providing statistical support for various early oncology trials. Prior to joining Merck in 2017, Thomas received his PhD in Biostatistics from the University of... Read More →
TG

Thomas Gwise

Division Director, Division of Biometrics IX, OTS, CDER, FDA
Thomas E. Gwise, Ph.D. is the Director of the Division of Biometrics IX. The Division, which is part of the Offices of Translational Science and Biostatistics in FDA’s Center for Drug Evaluation and Research, provides statistical expertise to the Office of New Drugs and the Oncology... Read More →
avatar for Yaping Wang

Yaping Wang

Mathematical Statistician, OB, OTS, CDER, FDA

Thursday June 18, 2020 9:30am - 10:30am EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session