STATUS: Active Project
CURE ID is a joint initiative between FDA and the National Institutes of Health (NIH) (implemented through the National Center for Advancing Translational Sciences [NCATS]) that includes an online platform and mobile app designed to capture case reports directly from healthcare providers worldwide. In these reports, healthcare providers describe how they use existing, approved drug therapies in new ways (i.e., “drug repurposing”) for the treatment of infectious diseases where there are currently limited or no effective therapeutic options. Recognizing the need to better understand the health outcomes of the different repurposed drugs used in the ongoing pandemic, this project will build a repository of COVID-19 case reports in CURE ID and will expand the platform’s capabilities to enable automated extraction and manual data collection from electronic health records (EHRs) and clinical disease registries.
Once completed, the expanded CURE ID platform will house tens of thousands of COVID-19 case reports, making it substantially larger than at present. This large collection of cases will enable 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. These signals will enable the generation of robust clinical hypotheses and by doing so, may accelerate the identification and development of effective treatments.
While the data infrastructure being built is specific for COVID-19, it is being designed in a sustainable manner so that it can be promptly deployed for future uses, including outbreaks of existing and emerging infectious diseases. This will provide real-time access to the global clinical experience of repurposing drugs when there is an immediate need to identify potential existing treatments in the absence of novel drug development.
PROJECT PURPOSE & OBJECTIVES
The goal of the project is to expand the existing infrastructure to enable collection of data from EHR and clinical disease registries into the CURE ID platform to support identification of promising COVID-19 treatments from the armamentarium of existing FDA-approved therapeutic products. The project has the following specific objectives:
- Develop partnerships with clinical consultants, technical consultants, and data providers to capture the most critical treatment and patient outcomes data from EHRs and registries;
- Build 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);
- Customize the CURE ID data fields to accommodate COVID-19-specific information available in EHRs;
- Make large quantities of de-identified patient-level data on COVID-19 treatment from many different sources rapidly and openly available;
- Expand clinician engagement and creation of global treatment networks and increase patient involvement in the platform;
- Identify promising drugs, drug combinations or treatment regimens for COVID-19 and other diseases with inadequate therapy from the data in CURE ID; and
- Ensure the sustainability and use of the CURE ID Platform’s EHR/registry expansion beyond COVID-19.