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’s Official COVID-19 Drugs page.
|TriNetX Rapid Querying||
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.
|Master protocol development: COVID-19 natural history||
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-demand queries and subsequent inferential studies. The protocol will be adaptable to various data sources with clinically rich data and will include specific populations of interest, such as the pediatric population, pregnant women, and other vulnerable populations identified by FDA.
|COVID MyStudies MobileApp for E-Consent||
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.
|Validation of hospitalized COVID-19 detected from claims-based algorithms||
The goal of this project is to conduct algorithm validation using diagnosis codes to identify potential hospitalized COVID-19 cases and validate the algorithm(s) using laboratory test results.
|Near real-time monitoring of critical drugs for the care of patients with COVID-19||This study aims to sequentially monitor priority drugs for the care of patients hospitalized with COVID-19, including sedatives and other drugs used to assist with mechanical ventilation, therapies for respiratory diseases, thrombolytics, anticoagulants, anti-infectives, and opioid analgesics. Drug utilization in the outpatient care setting will also be examined. The purpose of this activity is to assess changing patterns of use to support regional assessments of drug use and to assess for drug shortages.||In Progress||04/20/2020|
|Methods to monitor medical countermeasure safety and effectiveness||This ongoing methods development project by the FDA Office of Counterterrorism and Emerging Threats (OCET) to examine outcomes among hospitalized patients with influenza-like illness and acute respiratory disease is being expanded to also capture data on hospitalized patients diagnosed with COVID-19.||In Progress||04/20/2020|
|Horizon scan of electronic health record databases||The purpose of this project is to identify promising sources of electronic health records to strengthen the Sentinel System in areas of pediatric, cancer, pregnancy, birth outcomes, and cause-of-death data. With the start of the pandemic, a new focus was added to identify data sources capable of monitoring the diagnosis and treatment of COVID-19 patients.||In Progress||04/20/2020|
|Evaluating the impact of treatments used for COVID-19 using Real World Data||FDA will soon be launching several studies to monitor the treatment impact of drugs used in the public health response for COVID-19.||Planned||04/20/2020|