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
11/25/2020
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...
10/28/2020
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...
10/22/2020
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...
10/14/2020
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...
09/09/2020
This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Jeffrey Brown from...
08/19/2020
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, Judith C...
08/05/2020
This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Vincent Lo Re from the...
07/23/2020
This activity encompasses two aims that are using inpatient electronic health record data from HCA Healthcare:
Aim 1: The objective for Aim 1 is to describe the...
