FDA Launches App for Health Care Professionals

FDAThe U.S. Food and Drug Administration announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases. The repository is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is part of the National Institutes of Health (NIH).

"The CURE ID application focuses on drugs for infectious diseases lacking adequate treatments, including neglected tropical diseases, emerging infectious threats and infections caused by antimicrobial-resistant organisms. When health care professionals directly input their clinical cases into the app, CURE ID allows these real-world experiences to be organized and analyzed much faster, making it easier to spot promising new uses for existing drugs," said Amy Abernethy, M.D., Ph.D., FDA Principal Deputy Commissioner. "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."

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.

"The potential importance of new therapeutic opportunities from repurposing drugs can’t be understated," said NCATS Director Christopher P. Austin, M.D. "The CURE ID platform exemplifies how collaborative efforts can spark innovations that benefit patients. This new platform harnesses the power of crowdsourcing to help gather medical observations in the field and help identify potentially effective treatments for diseases."

The app works by collecting a simple case report form from caregivers about their experience using an approved product for an unapproved use. Health care professionals can browse from a collection of cases that have already been documented, including successful and unsuccessful treatments, in addition to viewing relevant clinical trials and those open to enrollment at clinicaltrials.gov. App users can also participate in a treatment discussion forum where they can engage with fellow providers globally. The FDA plans to reach out to health care providers in various disciplines, including infectious and tropical diseases, to encourage them to use 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 pilots, extensive user-testing was conducted in India (2015 and 2017) and South Africa (2016). Additional feedback was also collected from users in the U.S., Europe and Peru. The updated app that launched today includes the addition of a newsfeed, an improved search feature with data from 325 different infectious diseases and syndromes to choose from, and the inclusion of nearly 1,500 initial cases from clinicians and the published literature and over 18,000 clinical trials.

To download and use the CURE ID application, visit https://cure.ncats.io or download "CURE ID" from the App or Play Store.

About FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

AI-Pathway Companion Prostate Cancer fro…

AI-Pathway Companion Prostate Cancer(2), a digital companion from Siemens Healthineers to support clinical decision-making, has recently received the CE mark for use in the clinical pathway of prostate cancer, the...

Philips Launches HealthSuite System of E…

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the HealthSuite System of Engagement, an integrated, modular set of standards-based capabilities that support the development...

AI may Help Spot Newborns at Risk for Mo…

An artificial intelligence (AI) device that has been fast-tracked for approval by the Food and Drug Administration may help identify newborns at risk for aggressive posterior retinopathy of prematurity (AP-ROP)...

International Scientific Symposium DigiH…

13 November 2020, Pfarrkirchen, Germany DigiHealthDay @DIT-ECRI is going to be a daylong action-packed event targeting primarily academia - from established researchers, to young scientists and students. Following the theme "How...

Siemens Healthineers Introduces Teamplay…

Siemens Healthineers announces market introduction of the teamplay digital health platform. With the teamplay digital health platform Siemens Healthineers paves the way for healthcare providers' digital transformation - facilitating easy...

Digital Heart Model will Help Predict Fu…

In recent times, researchers have increasing found that the power of computers and artificial intelligence is enabling more accurate diagnosis of a patient's current heart health and can provide an...

Fighting Hand Tremors: First comes AI, t…

Robots hold promise for a large number of people with neurological movement disorders severely affecting the quality of their lives. Now researchers have tapped artificial intelligence techniques to build an...

Portable AI Device Turns Coughing Sounds…

University of Massachusetts Amherst researchers have invented a portable surveillance device powered by machine learning - called FluSense - which can detect coughing and crowd size in real time, then...

Oxford University Provide Evidence for C…

A team of medical research and bioethics experts at Oxford University are supporting several European governments to explore the feasibility of a coronavirus mobile app for instant contact tracing. If...

Buddy Healthcare Launches COVID-19 Remot…

Buddy Healthcare wants to help hospitals and healthcare professionals in the battle against the COVID-19. BuddyCare virtual care platform can be used for not only symptom tracking, remote monitoring and...

Preventicus Appoints Ljubisav Matejevic …

Preventicus is proud to announce that the company continues to grow by bringing its unique, comprehensive care management programs for prevention of strokes and cardiovascular events to new international markets...