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Regulatory Focus™ > News Articles > 2020 > 6 > UPDATED: FDA’s CURE ID app gets COVID-19 refresh

UPDATED: FDA’s CURE ID app gets COVID-19 refresh

Posted 12 June 2020 | By Kari Oakes 

UPDATED: FDA’s CURE ID app gets COVID-19 refresh

This article, originally published 10 June, was updated 12 June to include commentary from an FDA spokesperson.

An online case reporting platform has been optimized for COVID-19 and will be the springboard for a new public-private drug repurposing collaboration.
The CURE ID online platform was developed to allow clinicians to report off-label uses of drugs to treat infectious diseases, with the goal of generating hypotheses for further study of difficult-to-treat infectious diseases. The internet repository of these cases can also be accessed by clinicians and other users, with the option to view aggregated datasets as well as the individual case reports. The platform can be used via a computer browser or Apple and Android-based smartphone apps.
The updates to CURE ID, said the US Food and Drug Administration (FDA), will make the application “a more effective tool during the COVID-19 public health emergency.” The streamlined version targeted at COVID-19 has “data fields that have been harmonized with other real-world data and clinical trial platforms,” according to FDA. Adverse events entered into the app are also automatically shared with Medwatch, the FDA’s safety and adverse event reporting program. However, using the CURE ID app does not obviate the need for required regulatory and public health reporting.

"We have seen a vast increase in the use of the program, including the addition of more than 1000 new registered users in the past few months," said an FDA spokersperson. "More than 150 case reports of COVID-19 treatments that have been extracted from the published literature or entered by clinician users, with the data displayed as both the detailed individual case reports, and in an aggregated format. There has also been significant activity in the discussion forum – both on COVID-19 and other diseases."

Said the spokesperson, "While the app has always had a very streamlined, user-friendly case report form, we felt clinicians treating COVID-19 patients would want a form that more clearly focused on the things of greatest concern when treating this disease (i.e. was the diagnosis based on clinical, lab, and/or imaging findings, did the patient experience adverse events on the treatment, etc.)."

Regarding the app's utility, the spokesperson said, "We also wanted to be sure the data captured would have utility in conjunction with other data sources, so the data fields have been harmonized with other real-world data and clinical trial platforms. The app also allows clinicians to enter safety and efficacy data related to COVID-19 treatments simultaneously, with adverse events automatically shared with Medwatch."

Original collaborators on CURE ID included FDA and the National Center for Advancing Translational Sciences at the National Institutes of Health (NCATS/NIH).
These two agencies now join a new public-private partnership led by the non-profit Critical Path Institute (C-PATH). The collaboration plans to use CURE ID real-world data to aid in drug repurposing efforts, as well as in the advancement of clinical trials “for diseases of high unmet need,” according to C-PATH. The effort, dubbed the CURE Drug Repurposing Collaboratory (CDRC), includes other US and global stakeholders including regulatory bodies, non-government organizations and other private foundations.
The repurposing effort will use advanced analytics in a “transparent open forum,” said C-PATH, to promote the use of existing drugs for new indications, expand drug labels, and to assist regulators and regulatory professionals in developing a roadmap for drug repurposing for diseases with unmet need.
Within the larger CDRC effort, the COVID-19 pilot project will examine case report data on existing drugs that may have therapeutic benefit for COVID-19 patients. One advantage of the app-based approach to data collection is that it allows the contribution and use of data from patients who are not able to participate in clinical trials because of lack of eligibility or geographic constraints.

"The Collaboratory is up and running now and will be totally live next week. The pilot is the most significant focus for at least the first year, then we will aim to more significantly build out both other infectious disease areas, as well as rare oncology," said the FDA spokesperson.
A working group focused on the COVID-19 pilot plan to “reach out to systematically and widely encourage the sharing of clinical outcome data in an aggregable format and use it to generate hypotheses,” said C-PATH. “These data are publicly available and can be further analyzed to inform the design of clinical trials. In addition, real-world evidence will be assessed to determine what additional data would be necessary to advance drug repurposing for COVID-19.”
Those interested in joining the Collaboratory should send an inquiry to C-PATH is a public-private partnership with FDA that operates under the FDA’s Critical Path Initiative program.



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