in conjunction with ongoing clinical trial efforts.
“By utilizing thenow for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” , said during a June 9 webinar sponsored by the Food and Drug Administration. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.”
During the hour-long webinar, Ms. Stone, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research, demonstrated CURE ID, an Internet-based data repository first developed in 2013 as a collaboration between the FDA and the, a part of the National Institutes of Health (NCATS/NIH). It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. The app can be downloaded for free at . It can also be downloaded from the Apple app store or the Google Play store by searching “CURE ID.”
According to Ms. Stone, the platform’s three main goals are to enhance the understanding of new uses of approved medical products, to facilitate clinical trials and drug development, and to serve as a resource for physicians to share information where no FDA-approved product (which has been proven to be safe and effective) exists for the new use. CURE ID enables users to report their own cases as well as read cases of neglected infectious diseases with no sufficient approved therapies from other clinicians around the world. “It also enables clinicians to engage directly with communities of disease experts around the world, breaking down geographic and specialty silos,” Ms. Stone said. “It also enables them to access information on approved therapies for each disease and as well on active clinical trials.”
To date, CURE-ID contains information on 325 infectious diseases, including 1,580 case reports and 18,907 clinical trials. Initial pilot priority diseases include COVID-19, mycetoma, atypical mycobacteria, drug-resistant gonorrhea, rare and resistant fungal infections, as well as multidrug resistant gram-negative bacteria.
As of June 9, COVID-19-related data on the platform includes 151 case reports that have been extracted from the published literature or entered by clinician users, 80 discussion posts, and links to 694 clinical trials, 303 journal articles, 212 news articles, and 34 events. A total of 65 repurposed drugs have been identified as potential treatments for the virus, including 15 drugs with 10 or more cases.
“This facilitates clinicians reporting their real-world experiences treating COVID-19 patients, when patients are unable to be enrolled in a clinical trial,” Ms. Stone said. “It includes 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.” She pointed out that voluntary submission of cases to CURE ID is not a substitute for filing information with regulatory and public health authorities, where required. The platform also enables data to be entered and adverse events to be automatically shared with the FDA’s MedWatch Adverse Reporting System.
Ms. Stone concluded the webinar by announcing the formation of a new private-public partnership between theand the FDA and NCATS/NIH known as the . The effort will begin with a pilot project focused on furthering drug development for COVID-19 through use of 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,” Ms. Stone said. She reported having no financial disclosures.