FDA Sentinel System's Coronavirus (COVID-19) Activities

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 Sentinel Operations Center. It addresses the issue of a lack of standard metrics for describing data across systems and the utilization of data quality management (DQM) as a potential solution. 

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. Maro, and Jeff Brown from Sentinel Operations Center. The presentation includes both “Defining COVID-19 cohorts in real-world data” and “Data Type Considerations in Data Networks”. In “Defining COVID-19 cohorts in real-world data,” Noelle Cocoros provides considerations for cohort identification in claims and electronic health record (EHR) data in relation to real-world data studies. In “Data Type Considerations in Data Networks,” Judith C. Maro and Jeff Brown discuss commonly used electronic data types and the impact of missingness in study protocols.

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 University of Pennsylvania on behalf of the FDA Sentinel COVID-19 Coagulopathy workgroup. It includes updates to the specific aims previously presented on the June 5, 2020 and July 15, 2020 meetings such as the evaluation of arterial and venous thrombotic events separately and study outcomes considerations.

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 natural history of disease among hospitalized COVID-19 patients as identified based on diagnosis codes and/or laboratory results. This project will describe patients’ clinical characteristics, healthcare utilization, disease progression, and outcomes. Queries will be updated periodically to understand trends in the disease course and patient care over time.
 

Aim 2: The objective for Aim 2 is to establish the capacity to monitor critical drugs used in the care of hospitalized COVID-19 patients, and to sequentially monitor utilization through repeated data updates.
 

These projects build on the work conducted for the FDA’s Office of Counterterrorism and Emerging Threats (OCET) in understanding how the Sentinel System may be useful to study the safety and effectiveness of medical countermeasures.

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 University of Pennsylvania on behalf of the FDA Sentinel COVID-19 Coagulopathy workgroup. It includes updates to the study design previously presented on the June 5, 2020 meeting such as priority data sources, inclusions and exclusions within the cohort, and planned data elements.

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 University of Pennsylvania on behalf of the FDA Sentinel COVID-19 Coagulopathy workgroup. It includes the potential aims and methodology for “Descriptive Assessment of Coagulopathy Among COVID-19 Patients in the Inpatient Setting: A Sentinel Feasibility Study,” with a focus on thrombotic complications such as venous and arterial thromboses.

This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Mayura Shinde from Harvard Pilgrim Health Care Institute on behalf of the FDA Sentinel COVID-19 Coagulopathy workgroup.

The purpose of this project is to design and implement a system that enables rapid querying of electronic health record (EHR) data to support FDA's COVID-19 response. The project will partner with TriNetX to provide access to the TriNetX querying platform and TriNetX Live™ data network. On average 85% of the 60 U.S. healthcare organizations (HCOs) in the TriNetX Live™ data network refresh their data every two-to-four weeks. 

This activity supports investigators of COVID-19 related drug trials that need a digital platform for patient informed consent when face to face contact is not possible or practical. The COVID MyStudies application allows for secure and remote electronic consent. The end product is a signed consent form emailed to the patient or legally authorized representative and a copy which the investigator can access in a secure and compliant manner through the platform. The investigator can print the form or transfer an electronic copy into another electronic system. Under the FDA-Catalyst program, the Sentinel Operations Center will coordinate the branding and administration of this application. 

Funding for use of this system by Investigators, Healthcare delivery systems, and Sponsors is provided by the FDA. COVID MyStudies is currently available in the Apple App and Google Play Stores. Investigators, Healthcare delivery systems, and Sponsors can contact CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov to get started.

More information about COVID MyStudies can be found here.