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CURE ID: Aggregating and Analyzing COVID-19 Treatments from EHRs & Registries Globally

CURE ID: Aggregating and Analyzing COVID-19 Treatments from EHRs & Registries Globally
Agency
  • Food and Drug Administration
Start Date
  • 5/01/2021
OS-PCORTF Strategic Plan Alignment
  • Primary: Goal 1: Data Capacity for National Health Priorities

 

STATUS: Completed Project

BACKGROUND 
CURE ID, a collaboration between the U.S. Food and Drug Administration (FDA) and National Center for Advancing Translational Sciences at the National Institutes of Health (NIH/NCATS), is a web-based application designed to capture case reports directly from healthcare providers, patients, and their caregivers describing how they use existing, approved drug therapies in new ways (i.e., “drug repurposing”) for the treatment of diseases where there are currently limited or no effective therapeutic options.  

In the initial stages of the COVID-19 pandemic, the rapid emergence and spread of the disease left limited time for developing new, effective treatments. To better understand the health outcomes of the different repurposed drugs used in the COVID-19 pandemic, this project built a repository of COVID-19 case reports in CURE ID and expanded the platform’s capabilities to enable automated extraction and manual data collection from electronic health records (EHRs) and clinical disease registries. The resulting collection of more than 115,000 COVID-19 cases can be used by the clinical, research, and regulatory communities to identify signals of potentially safe and effective COVID-19 treatments from amongst the existing therapeutics approved by FDA and similar regulatory authorities in other countries, potentially accelerating the identification and development of effective treatments. 

PURPOSE 
This project aimed to expand existing infrastructure to enable the collection of data from EHRs and clinical disease registries into the CURE ID platform by:

  • Developing partnerships with clinical consultants, technical consultants, and data providers to capture the most critical treatment and patient outcomes data from EHRs and registries. 
  • Building the infrastructure, technology, and methodology needed to extract and aggregate targeted clinical data from many global sources (EHRs, registries, and clinician-submitted and published cases). 
  • Customizing CURE ID data fields to accommodate COVID-19-specific information available in EHRs. 
  • Making large quantities of de-identified patient-level data on COVID-19 treatment from many different sources rapidly and openly available. 
  • Expanding clinician engagement and creation of global treatment networks and increasing patient involvement in the platform.
  • Identifying promising drugs, drug combinations, or treatment regimens for COVID-19 and other diseases with inadequate therapy from the data in CURE ID. 
  • Ensuring the sustainability and use of the CURE ID platform’s EHR/registry expansion beyond COVID-19.

KEY IMPACTS 
Providing more relevant, comprehensive data: Expanding CURE ID to include COVID-19 cases 
The project team enabled the CURE ID platform to capture new variables on COVID-19 and draw from new sources of data including EHRs, clinical disease registries, and a patient or caregiver-completed form on Long COVID treatment experiences. Added data elements include those on COVID-19, non-medical factors, and more expansive information on demographics, characteristics of interventions and comparators, and outcomes, among other elements

Improving access and use of data: CURE ID Platform 
To improve clinician and researcher access to and use of timely data on COVID-19 treatments, the project made de-identified patient-level cases available via the CURE ID platform and made the platform accessible to researchers, as well as the broader community of patients, caregivers, clinicians, policymakers, and others. 

PUBLICATIONS: 
CURE ID Database. The CURE ID Database captures over 115,000 acute COVID-19 treatment cases from seven healthcare systems representing more than 100 hospitals in the U.S. and more than 585 cases submitted by patients with Long COVID, as well as their caregivers and clinicians. The capability for patients to report has continued to be refined for Long COVID, MPOX, RASopathies, Sarcoma, and other diseases.

CURE ID and EHR Data Dictionary. This resource provides guidance on the CURE ID data elements included in the EHR-extracted data, how they were defined, and the types of response values.

CURE ID Researcher’s Guide. This guide summarizes data processing and pathways, data sources and characterization, data access, data security, data quality assurance, and frequently asked questions to inform research use and exploration of the data in CURE ID.

CURE ID Data Extraction Toolkit/Guidance Documents. The open-source code for the automated data extraction tool is available on GitHub. The tool allows users to capture targeted fields from diverse EHRs and registries globally.

CURE ID Report on COVID-19 Outcome Measures of Importance to Patients. This report captures findings from interviews conducted with four patients to identify COVID-19 outcome measures important to patients that could be collected via CURE ID.

CURE ID Patient Case Report Form. Patients with any disease or their caregivers can submit a case report form for their condition in CURE ID. This includes a generic patient case report form that mimics the generic clinician case report form for most diseases, as well as disease-specific case report forms for Long COVID, MPOX, RASopathies, and Sarcoma.