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Session 9: Understanding Logistical and Regulatory Barriers to Using Real-World Data in New Drug Applications or Supplements
Session Chair(s)
Yueqin Zhao, PhD
Lead Mathematical Statistician, OB, OTS, CDER
FDA, United States
Judith C. Maro, PhD, MS
Assistant Professor, Department of Population Medicine
Harvard Medical School, United States
This session is designed to introduce biostatisticians to some of the regulatory concerns when using Real-World Data to support New Drug Applications or Supplemental New Drug Applications. Prior use cases include real world data as external control arms primarily in cancer and rare disease therapeutic areas. Real-World Data holds many promises to enhance data from what would otherwise be single arm trials, however use of data not owned by the sponsor brings logistical and statistical challenges for incorporation. Data granularity and access can be significantly different from data gathered explicitly to support the trial.
Learning Objective : - Discuss the differences in types of Real-World Data that might be considered for incorporation into applications
- Understand the added complexities for incorporating RWD into applications
- Discuss the regulatory considerations associated with use of data not owned by the sponsor
Speaker(s)
Real-World Evidence Data Landscape
Mary Elizabeth Ritchey, PhD
Med Tech Epi, LLC, United States
Principal and Owner
Regulatory Considerations for Access to Real-World Data
Stefanie Kraus, JD, MPH
FDA, United States
Senior Regulatory Counsel, Office of Regulatory Policy, CDER
Presentation of Use Case and Statistical Considerations
Sajan Khosla, MSc
AstraZeneca, United Kingdom
Executive Director, Head of Real World Evidence, Oncology R&D
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