An App for “systematic collection of real-world experience”

From the FDA:

CURE ID is an internet-based repository that lets the clinical community report novel uses of existing drugs for difficult-to-treat infectious diseases through a website, a smartphone or other mobile device. The platform enables the crowdsourcing of medical information from health care providers to facilitate the development of new treatments for neglected diseases. CURE ID is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). FDA and NIH are also collaborating with the World Health Organization and the Infectious Disease Society of America to assess the global utility of the CURE ID platform for COVID-19 case information.

The repository captures clinical outcomes when drugs are used for new conditions, 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 serve as a resource for physicians to share information where no FDA-approved product proven to be safe and effective exists for the new use. Repurposing approved drugs for new clinical uses can potentially offer an efficient drug-development pathway for treatments of diseases and conditions that have few or no therapeutic options.

The app works by collecting a simple case report forms from healthcare providers about their experience using an approved product for an unapproved use. Users can browse from a collection of cases that have already been documented, including results of treatment, 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.

Effective Tool in the COVID-19 Public Health Emergency

FDA and NCATS have made critical updates to CURE ID to be a more effective tool in the COVID-19 public health emergency. These updates allow clinicians to more easily report their real-world experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial.

There is now an updated case report form tailored to COVID-19 and 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).

The full case report form remains highly focused and can be completed in a few minutes by any staff member with access to the patient’s medical records.

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. All users can see the de-identified data that clinicians submit through the electronic case report form. These data are available as full individual case reports as well as multiple reports aggregated together, providing real-time information and complete data transparency.

CURE ID was initiated in 2013 and promises to be a long-term initiative, as the Critical Path Institute 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.

 

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