|
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
|
|
Abstract:
|
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.
