FDA’s Clinical Methodologies Group (ClinMeth) within CDER’s Office of Medical Policy received a $9.2 million grant through the HHS Office of the Assistant Secretary for Planning and Evaluation’s (ASPE) Patient Centered Outcomes Research Trust Fund.
The ASPE grant will fund expansion of the CURE ID platform to allow automated data collection from electronic health records (EHR) worldwide and clinical disease registries for COVID-19 and other difficult-to-treat infectious diseases.
CURE ID is a web-based platform and mobile application that allows the global clinical community to share novel uses of existing drugs for challenging infectious diseases. CURE ID was developed by FDA and NIH’s National Center for Advancing Translational Sciences (NCATS). The Critical Path Institute is now convening a public-private partnership for CURE ID in collaboration with FDA and NCATS. The public-private partnership is known as the CURE Drug Repurposing Collaboratory.
Over the next two years, ClinMeth will work with hundreds of medical institutions to expand CURE ID to include EHR and registry data. As part of the expansion, ClinMeth will work with Johns Hopkins to develop a tool to automate the extraction of data elements from EHRs and registries into the CURE ID case report form. This infrastructure is being built for COVID-19, but it is also designed for future outbreaks of existing and emerging infectious diseases.
The data enhancement will enable health care providers and researchers interested in patient-centered outcomes research for COVID-19 and other infectious diseases to have access to comprehensive (de-identified) case reports on tens of thousands of patients, including treatment outcomes, such as recovery, deterioration, hospitalization, ICU admission, and death.
By enabling data extraction in an automated fashion, CURE ID may facilitate the clinical, research, and regulatory communities to identify signals of potentially safe and effective COVID-19 therapies. These treatments may be candidates for additional study in randomized clinical trials.