Off-Label Coronavirus Therapies Become Crowdsourced

The US Food and Drug Administration (FDA) has announced the digital repository CURE ID now empowers the clinical community to report novel uses of existing drugs for difficult-to-treat infectious diseases, such as COVID-19 disease.

The FDA has made critical updates to CURE ID to be a more effective tool in the COVID-19 public health emergency. 

These updates include allowing clinicians to more easily report their real-world experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial.

The CURE ID digital platform enables the 'crowdsourcing' of medical information from healthcare providers to facilitate the development of new treatments for neglected diseases, said the US FDA on June 10, 2020.

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. 

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 CURE ID app also allows clinicians to enter data related to COVID-19 treatments, with adverse events automatically shared with Medwatch.

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.

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 CollaboratoryExternal Link Disclaimer. 

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.

Individuals can download the CURE ID app by searching for “CURE ID” in the iTunes App or Google Play Store.

Institutions interested in partnering with the Collaboratory are encouraged to contact [email protected].

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.

Precision Vaccinations publishes coronavirus therapeutic development news.