USA – FDA updates platform for off-label drug use

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. »…