The U.S. Food and Drug Administration announced the launch of CURE ID, an internet-based repository that enables the clinical community to report their experiences treating infectious diseases with novel uses of existing FDA-approved drugs, such as medications and vaccines. By enabling healthcare provider-generated crowdsourcing of pertinent medical information to guide potentially life-saving interventions, the hope is that this new tool will facilitate the development of new drugs for neglected diseases.
Key Value Proposition
A key value proposition driving the public expenditure is that the repurposing of 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. Put another way, the platform “harnesses the power of crowdsourcing to help gather medical observations in the field and help identify potentially effective treatments for diseases,” reported NCATS Director Christopher P. Austin, MD.
What is CURE ID?
An online repository, accessible form websites, smartphones or other mobile devices, to capture clinical outcomes when approved drugs are used for new indications, in new populations, in new doses or in new combinations.
How does it Work?
It works by collecting a simple case report form from caregivers about their experience using an approved product for an unapproved use. For example, healthcare professionals simply browse the website and access a collection of cases already documented, including successful and unsuccessful treatments, in addition to viewing relevant clinical trials as well as those open to enrollment at Clinicaltrials.gov. App users can also participate in a treatment discussion forum where they can engage fellow providers globally. The FDA will reach out to health care providers in various disciplines, such as infectious and tropical diseases, to encourage usage.
Who Sponsored and Funded the Site?
CURE ID is the result of a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS)—part of the National Institutes of Health (NIH).
Why is this Important?
The FDA is driving toward the generation of more “real-world” data generation and analysis within healthcare. The agency seeks to leverage “Digital” to accelerate innovation and drive efficiencies (and reduce costs) that are typically associated with research. If the tool is extensively used it opens up a powerful repository of knowledge for researchers to glean actionable insight.
Dr. Amy Abernethy, principal deputy commissioner at the FDA, noted that “Our hope is that this app will serve as a connector among major treatment centers, academics, private practitioners, government facilities and other health care professionals from around the world and ultimately get treatments to patients faster.”
Background on the Development of the App
The full launch of the app follows the release of several pilot versions after an initial innovation award was received from the U.S. Department of Health & Human Services IDEA Lab in April, 2015. During the pilot phases extensive user-testing was conducted in India (2015-2017) and South Africa (2016). Additional feedback was collected from users in America, Europe and Peru. The updated app includes an additional newsfeed, improved search feature with data from 325 different infectious diseases and syndromes to chose from, and inclusion of nearly 1,500 initial cases from clinicians and published literature and over 18,000 clinical trials.
Call to Action: Check out the CURE ID site.