FDA’s Sentinel System is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic, ranging from monitoring the use of drugs, describing the course of illness among hospitalized patients, and evaluating the treatment impact of therapies actively being used under real-world conditions. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity and also visit:
FDA Sentinel System's Coronavirus (COVID-19) Activities
Sentinel Projects
04/02/2021
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐...
02/26/2021
Administrative claims data, which comprise most of the data in the current Sentinel Distributed Database, are limited in their ability to study severely ill hospitalized patients,...
02/24/2021
The Sentinel System can be used to address numerous questions of importance to FDA during the COVID‐19 pandemic. One population of significant interest for study is pregnant women....
12/21/2020
Among hospitalized non-pregnant adults with COVID-19, we aimed to describe the number of patients with hospitalized thrombotic events or death through 28 days. We stratified each outcome...
11/24/2020
To inform future sample size calculations pertaining to thrombosis in COVID-19-associated coagulopathy, we describe occurrence of thrombotic events and death among patients aged 40-79...
10/27/2020
This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Noelle Cocoros from...
10/21/2020
The goal of this project is to describe the natural history of coagulopathy among COVID-19 patients in the inpatient setting. Activities will include development of a study synopsis for...
10/13/2020
The COVID-19 Natural History Master Protocol effort involves the development of a protocol designed to identify multiple COVID-19 cohorts to support a variety of on-...
09/14/2020
This project supports FDA’s COVID-19 response through:
- Adding COVID-19 laboratory results data to the Sentinel Common Data Model (SCDM) for routine querying in the Active...
