FDA and NIH Make Updates to CURE ID App to Speed Drug Development During the COVID-19 Public Health Emergency

FDA and NIH Make Updates to CURE ID App to Speed Drug Development During the COVID-19 Public Health Emergency

Agencies Launch Public-Private Partnership Called the CURE Drug Repurposing Collaboratory  

The U.S. Food and Drug Administration (FDA) and National Center for Advancing Translational Sciences at the National Institutes of Health (NCATS/NIH) have made updates to the CURE ID application to be a more effective tool during the COVID-19 public health emergency.  CURE ID is an internet-based repository that allows clinicians to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing drugs through a website, a smartphone or other mobile device. Clinicians can also access cases entered by other users and view them as individual case reports or an aggregated dataset.

FDA and NCATS/NIH are also collaborating with the National Institute of Allergy and Infectious Diseases at NIH, the Centers for Disease Control and Prevention, the Critical Path Institute (C-Path), the World Health Organization and the Infectious Diseases Society of America  to assess the global utility of the CURE ID platform for COVID-19 case information. Healthcare providers worldwide are encouraged to share their COVID-19 treatment experiences via the CURE ID platform. 

FDA and NIH have made updates to the platform to allow clinicians to more easily report their experiences treating COVID-19 patients (with either positive or negative treatment outcomes) who are unable to be enrolled in a clinical trial.

The full case report form remains highly focused and can be completed in a few minutes. It can be entered by any staff member with access to the patient’s medical records. The goal of the case reporting is to generate hypotheses to be further studied in randomized clinical trials.

With these updates, CURE ID now includes a revised case report form tailored to COVID-19 with data fields that have been harmonized with other real-world data and clinical trial platforms. The app also allows clinicians to enter data related to COVID-19 treatments, with adverse events automatically shared with Medwatch. (Voluntary submission of cases to CURE ID is not a substitute for filing information with regulatory and public health authorities, where required).

CURE ID includes information on almost all clinical trials submitted to clinicaltrials.gov for COVID-19 drugs, biologics, and vaccines as well as relevant journal articles, news articles and events, with these items updated nearly daily. Case reports extracted from the published literature and displayed with aggregated data are also available.

CURE ID was initiated in 2013 and promises to be a long-term initiative, as C-Path is convening a public-private partnership on behalf of FDA and NCATS called the CURE Drug Repurposing Collaboratory. It will begin with a pilot focused on furthering drug development for COVID-19 through the CURE ID platform. The Collaboratory will demonstrate how data shared from clinicians in real-time can be used to inform ongoing and future clinical trials, and potentially drug labeling.

Individuals can visit the website here or download the app by searching for “CURE ID” in the iTunes App or Google Play Store. Institutions interested in partnering with the Collaboratory are encouraged to contact cdrc@c-path.org.