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Opening Remarks and Session 6: Objectivity and Transparency: Roundtable Discussions on Real-World Studies to Support Regulatory Decision-making
Session Chair(s)
Sarah Martin, PhD, MS
Senior Director - Global Regulatory Policy (Oncology)
Eli Lilly & Co., United States
Opening Remarks and Session 6: Objectivity and Transparency: Roundtable Discussions on Real-World Studies to Support Regulatory Decision-making
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss opportunities and challenges with the use of RWE for regulatory decision making
- Explain ‘objectivity’ in the context of real-world (RW) studies and why it is important, and how emulating the scientific and operational processes from a gold-standard randomized, controlled clinical trial helps maintain objectivity in RW studies
Speaker(s)
Real-world Studies to Support Regulatory Decision-making: The What and the How?
Rohini Hernandez, PhD, MPH
Amgen, United States
Director, Center for Observational Research
Trial Emulation Beyond Study Design: Meeting Regulatory Standards for Objectivity in Real-World Studies
Brian Conroy, PhD, MS
Aetion, United States
Senior Director of Biostatistics