The CURE Drug Repurposing Collaboratory (CDRC) is a public-private partnership initiated in June 2020 by C-Path and the U.S. Food and Drug Administration (FDA) in partnership with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH).
CDRC, in partnership with the FDA-NCATS CURE ID* platform, is a dedicated initiative designed to capture real-world clinical outcome data to advance drug repurposing and inform future clinical trials for diseases of high unmet medical need. The initiative includes emerging/reemerging diseases, anti-microbial drug resistant infections, neglected infectious diseases as well as rare oncology diseases where there are limited treatment options. The Collaboratory is strongly interested in capturing data from diverse populations including pediatric and pregnant women. C-Path leads CDRC, with participation from a diverse set of global stakeholders including, but not limited to, clinicians, scientists, U.S. Health and Human Services (HHS) agencies, non-government organizations, foundations and societies in order to:
- Promote the CURE ID platform to enable the global health community to openly share patient treatment outcomes
- Evaluate drug leads through advanced analytics to identify candidates for repurposing as new treatments in a transparent open forum
- Inform the design of clinical trials of existing marketed drugs for new indications
- Generate real-world evidence for expanding drug labels
- Provide a regulatory roadmap to advance drug repurposing and expedite the availability of safe and efficacious treatments for diseases with limited or no treatment options
* The CURE ID mobile app is an FDA-NCATS collaboration to build an internet-based repository that allows the global clinical community to report novel uses of existing drugs to treat diseases through a website, a smartphone, or other mobile device. The repository captures the clinical outcomes when drugs are used for new indications, in new populations, in new doses, or in new combinations.
COVID-19 Pilot Project
CDRC’s pilot project focuses on COVID-19. With no approved therapy available, the SARS-CoV-2 pandemic has led clinicians to treat patients with off-label drugs and/or different drug combinations, doses and regimens. Gathering much-needed data from clinicians about their COVID-19 patients’ medical outcomes can generate vast amounts of data on a global scale. To address this need, the CURE ID platform will be used to capture individual case reports and serve as the single centralized source of reliable curated publicly available information for COVID-19. The platform will be coordinating with the FDA Adverse Event Reporting System (FAERS) to collect both safety and efficacy data so health care providers do not need to submit duplicate reports.
Data collected via the CURE ID platform will be aggregated and used by CDRC in an attempt to identify existing drugs that demonstrate possible therapeutic benefits for COVID-19 and should be studied further in appropriately powered randomized clinical trials (RCTs) to identify a safe and effective treatment. However, many COVID-19 patients are unable to participate in RCTs because they do not meet eligibility criteria or do not live near a clinical trial site. Furthermore, is it not feasible that every patient can be enrolled in an RCT given the lack of a centralized infrastructure. As a result, hundreds of thousands of patients are likely to receive treatment outside of RCTs.
The COVID-19 working group will reach out to systematically and widely encourage the sharing of clinical outcome data in an aggregable format and use it to generate hypotheses. 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.
Immediate Call to Action for Physicians, Health Care Providers and Organizations:
- Download the CURE ID app today. Without a treatment for COVID-19, thousands more will succumb to the disease. We need your help. Download the app at (https://cure.ncats.io/) and begin submitting cases today. It takes a couple minutes and every case report counts.
- Participate, submit, and discuss cases using the CURE ID platform. Thousands of patient records need to be submitted to find a potential efficacy signal. The current COVID-19 pandemic has left physicians without the tools to effectively treat SARS-CoV-2 patients. As a result, COVID-19 patients are being treated by several drugs off-label. The need to capture and share this data is imperative to help inform clinical trials as well as identify potential signals through real world evidence. The variability in patients’ comorbidities, number of drugs administered, drug doses, as well as disease progression and patient status are just a few variables that will need to be considered.
- To join the CURE Drug Repurposing Collaboratory, please send inquiries to [email protected].
The CURE Drug Repurposing Collaboratory is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award 2U18FD005320 totaling $1,103,978 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.