CURE ID App for Infectious Disease Case Reporting

National Center For Advancing Translational Sciences

Investigators

Abstract

The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) announced the global launch of CURE ID on December 5, 2019. The repository is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is part of NIH. Additionally, FDA and NIH are collaborating with the World Health Organization (WHO), the Infectious Diseases Society of America (IDSA), the Critical Path Institute (C-Path), and other partners to assess the global utility of the CURE ID platform. The repository captures clinical outcomes when drugs are used for new indications, in new populations, in new doses or in new combinations. Health care professionals generally may choose to prescribe or use a legally marketed human drug or medical device for an unapproved or uncleared use when they judge that the unapproved use is medically appropriate for an individual patient. The systematic collection of real-world experience in the app will help identify drug candidates for additional study, encourage further drug development, and may serve as a resource for practitioners making individual patient treatment decisions in the absence of established safe and effective options. Repurposing approved drugs for new clinical indications can potentially offer an efficient drug-development pathway for treatments of diseases and conditions that have few or no therapeutic options. In the context of the COVID-19 global pandemic, FDA announced the launch of a new Partnership to use the CURE ID platform to capture real-world data to identify potential treatments for further study. The National Center for Advancing Translational Sciences (NCATS) is partnering with FDA and the Critical Path Institute (C-Path) on the CURE Drug Repurposing Collaboratory (CDRC). CDRC will provide a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in these areas. CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID platform. Expansion of the CURE ID platform includes data collection from electronic health records (EHRs), successful launch of COVID-19 and MPOX (formerly Monkeypox) case reports forms, and a pilot project focused on Sarcoma. Further development will foster increased global engagement and diversification into a wider range of disease domains.