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. NCATS partners with FDA and the Critical Path Institute (C-Path) on the CURE Drug Repurposing Collaboratory (CDRC) producing CURE ID as the repository of information. The CURE ID platform expansions include case report forms and reporting for sarcomas, rasopathies, rare cancers, rare genetic disorders and a wide variety of other diseases. Further development will foster increased global engagement and diversification into a wider range of disease domains.