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Activity Number: 153 - Utilization of Historical Data for Confirmatory Trials
Type: Topic Contributed
Date/Time: Tuesday, August 4, 2020 : 10:00 AM to 11:50 AM
Sponsor: Biopharmaceutical Section
Abstract #309859
Title: Use of Historical Data in Regulatory Applications – Advantages and Challenges
Author(s): Shiowjen Lee*
Companies: FDA/CBER/OBE/DB
Keywords: historical data; historical control; rare disease

Randomized controlled trials has long representing the gold standards for the approval of a medical product. They are not without limitations. For example, there are logistically, analytically as well as ethical concerns in trials for rare diseases. Modernization of product development and approval have been advocated. This includes numerous explorations and understanding of the roles of historical data in the approval of medical products. The known issues of using historical data include the temporal effect and bias when use publications to extract historical data or/and historical controls. These issues have made its use challenging in the interpretation of trial results. In this talk, I will present FDA’s experiences and approaches in the use of historical data in regulatory decision making and medical products approval. Examples and case studies will be included.

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

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