|
Activity Number:
|
605
- Innovations in Use of Historical Control Data in Clinical Trials
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Thursday, August 1, 2019 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
|
Abstract #306960
|
Presentation
|
|
Title:
|
Exploring External Controls Using Prior Clinical Trial Data
|
|
Author(s):
|
Pallavi Mishra-Kalyani*
|
|
Companies:
|
US Food and Drug Administration
|
|
Keywords:
|
Non-randomized data;
External controls;
Real world data
|
|
Abstract:
|
The establishment of comparative efficacy using data from sources other than traditional randomized control trials growing interest in the scientific community. One possible design is to include data from a prior clinical trial to replace or augment the control arm when comparing to an experimental therapy. Using clinical trial data submitted to the FDA for new drug and biologic applications, the use of external controls from prior clinical trials is considered as an option for identifying the comparative treatment effect of newer therapies.
|
Authors who are presenting talks have a * after their name.
