In the race to find safe and effective treatments or cures for COVID-19, health care providers have been looking to repurpose existing drugs in addition to developing new treatment options. Repurposing drugs entails using drugs shown to be safe and effective in humans for one disease and identifying their potential use for other diseases or conditions. It can take 10 to 15 years and significant financial and logistical investment to bring new drugs to market, according to the Pharmaceutical Research and Manufacturers of America. Time is of the essence during a pandemic, and studying existing drugs that may have additional applications can potentially reduce these investments and cut down on the time needed to develop treatments.
Drug repurposing is not a new concept brought about by COVID-19. In recent years, drug repurposing has been gaining traction in the medical community because of its time and cost savings and potential patient care benefits. In fact, FDA and the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) formally launched the CURE IDExternal Link Disclaimer application in December 2019. CURE ID allows health care providers to report new uses of existing drugs for 325 difficult-to-treat, infectious diseases through a standardized and simple case report form (CRF) from a website or mobile device. Users can browse from a collection of cases that have already been documented, including results of treatment, in addition to viewing relevant clinical trials and those open to enrollment at clinicaltrials.gov. App users can also participate in a treatment discussion forum where they can engage with fellow providers globally.
In 2020, the Critical Path Institute (C-Path) convened a public-private partnership in collaboration with FDA and NCATS/NIH called the CURE Drug Repurposing CollaboratoryExternal Link Disclaimer (CDRC) for ongoing management of the CURE ID program and expansion of its partnerships. The CDRC currently has participants from more than 30 partner organizations.
Automating the data
The CURE ID program, run at FDA by the Clinical Methodologies Group (ClinMeth) within CDER’s Office of Medical Policy, planned on expanding the app by adding other illnesses, but as a new disease that has caused a pandemic, COVID-19 has expedited the process. To make the app more effective during this public health emergency, ClinMeth created a user-friendly CRF tailored to COVID-19 and included 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. With so many health care specialists working on COVID-19, the ability to systematically capture and learn from other providers’ treatment experiences is invaluable.
To obtain more COVID-19 treatment-related information, ClinMeth received a $9.2 million grant in March 2021 through the HHS Office of the Assistant Secretary for Planning and Evaluation’s Patient Centered Outcomes Research Trust Fund. This grant will allow ClinMeth to work with partners over the next two years to expand the open-access CURE ID platform of case reports to include anonymized electronic health record (EHR) and registry data. The CDRC will serve as the partnership coordinating center for the grant.
The expansion will enable access to data from around 300 hospitals, through four primary institutional partners: The Society of Critical Care Medicine’s VIRUS Registry, Johns Hopkins School of Medicine, Emory School of Medicine, and the University of California San Francisco. In addition, CDRC has partnered with the Infectious Disease Data Observatory at Oxford University to collaborate and harmonize with international data collection efforts. Partners at Johns Hopkins are developing a tool to automate the extraction of data elements from EHRs and reg...
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