1. Home
  2. Science & Research
  3. About Science & Research at FDA
  4. The FDA Science Forum
  5. Walking the Talk- Harnessing COVID-19 EHR Data to Inform Clinical Trial Design Using CURE ID
  1. The FDA Science Forum

2021 FDA Science Forum

Walking the Talk- Harnessing COVID-19 EHR Data to Inform Clinical Trial Design Using CURE ID

Download the Poster (PDF; 0.88 MB)
Authors:
Poster Author(s)
Nhundu, Belinda, C-Path; Paul, Parvesh, NCATS/NIH; Duggal, Mili, FDA; Stone, Heather, FDA; Charles, Reema, C-Path; Borkowski, Katarzyna, FDA; Sacks, Leonard, FDA; Schito, Marco, C-Path; Gorobet, Serghei, NCATS/NIH; Nieves, Dominic, NCATS/NIH; Sheils, Timothy, NCATS/NIH; Geng, Ruby, NCATS/NIH; Garcia Aviles, Marco, NCATS/NIH
Center:
Contributing Office
Center for Drug Evaluation and Research

Abstract

Poster Abstract

Background 

The COVID-19 pandemic has brought great attention to both the opportunity presented by drug repurposing, as well as the challenges of harnessing real-world data to generate clinical evidence. 

Purpose

The CURE ID platform developed collaboratively by the FDA and NCATS/NIH is an open-access mobile application and website that allows clinicians globally to share their clinical experience with repurposed drugs. CURE ID serves as a real-world data repository allowing for systematic case-sharing while simultaneously being a platform for rapid communication and discussion for healthcare providers during an outbreak. Currently CURE ID relies on manual data extraction, which is time-consuming, and unsustainable. Electronic Health Records (EHR) and registries provide a larger source of available data that can be probed electronically without requiring additional effort by healthcare providers, serving as a powerful resource to identify potential treatments for COVID-19, pending the development of new drugs.

Methodology and Results

CURE ID in collaboration with the Society of Critical Care Medicine (SCCM)/Mayo Clinic’s VIRUS Registry and the Johns Hopkins School of Medicine is developing an automated extraction tool to enable data from several different EHR and registry systems to be extracted and converted into the CURE ID format. This will leverage data from more than 250 participating sites. The CURE ID expanded platform will provide healthcare providers and researchers interested in patient-centered outcomes research with open access to case reports on patients including treatment outcomes. The expanded CURE ID platform is expected to include over 100,000 new cases within the next year. 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 armamentarium of existing FDA approved therapeutics that could then be studied further in randomized controlled trials. 

Conclusion 

Expansion to EHR and registry data will enable the generation of robust clinical hypotheses and by doing so, may accelerate the identification and development of effective treatments.
Inclusive partnerships with all stakeholders – public and private sectors partners, academia, policy makers and most importantly patients will leverage our comparative strengths and respective voices towards collective solutions to identify safe and effective treatments.

Poster Image
Preview image of the scientific poster. For more information, please refer to the abstract or download the PDF version of the poster.

Download the Poster (PDF; 0.88 MB)

Back to Top