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Activity Number: 493 - Leveraging Historical Data and Real World Evidence in Drug Development Program Evaluation
Type: Topic Contributed
Date/Time: Wednesday, July 31, 2019 : 10:30 AM to 12:20 PM
Sponsor: Health Policy Statistics Section
Abstract #304151
Title: From Quantitative Drug Safety to Real-World Evidence: Activities at the US FDA
Author(s): Hana Lee* and Mark Levenson
Companies: U.S Food and Drug Administration and FDA CDER
Keywords: FDA; Drug efficacy ; Drug safety; Real-world data; Real-world edivence

In the last decade, the FDA has initiated numerous efforts to continue to improve its evaluations of drug safety both in the premarket and post-market realms. These efforts have entailed making use of novel data sources and novel statistical designs and analyses. Recently there have been increased interests in making additional use of novel data sources to provide evidence of efficacy, an area known as real-world evidence. Under the 21st Century Cures Act, the FDA is required to develop a program to evaluate the use of real world evidence to help support the approval of a new indication for an approved drug or to satisfy post approval study requirements. This talk will review the FDA drug safety and RWE efforts and provide some illustrative examples.

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

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