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Activity Number: 150 - Lead with Statistics in Medical Device Innovations and Beyond
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #328414 Presentation
Title: Use of Real-World Data and Real-World Evidence for Regulatory Decisions: Opportunities and Challenges
Author(s): Lilly Yue* and Nelson Lu and Yunling Xu
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration and FDA/CDRH
Keywords: Real-world data; Real-world evidence; Regulatory decision-making

There are many sources of real world healthcare data that could be leveraged in the clinical studies in the regulatory settings. While such large quantities of data reflect real world clinical practice and could potentially be used to reduce the cost of clinical trials, challenges arise concerning real-world data (RWD) quality, innovative methods for developing robust real-world evidence (RWE) from RWD, and appropriate use of RWE for regulatory decisions. This presentation will discuss such opportunities and challenges from statistical and regulatory perspectives, illustrated with real examples in both therapeutic and diagnostic device areas from regulatory submissions.

Authors who are presenting talks have a * after their name.

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