2021 FDA Science Forum
A Rapid Query Model to Prioritize COVID-19 Questions from a Real-World Clinical Data Warehouse in California
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Contributing OfficeOffice of the Commissioner
Abstract
Background
The urgency of the COVID-19 pandemic demands development of new approaches to answer critical research and operational questions quickly. Real-world data (RWD) sources are particularly well-suited to address these needs. The United States Food and Drug Administration (US FDA) initiated this proposal with the University of California Health System (UC-Health) within the Center of Excellence in Regulatory Science and Innovation (CERSI) collaboration.
Methods
UC-Health, with 19 health professional schools, 5 academic medical centers, and 12 hospitals, has built a secure central EHR based data warehouse (UC Health Data Warehouse, or UCHDW) for operational improvement, promotion of quality patient care, and to enable the next generation of clinical research. Since the start of the COVID-19 pandemic, the University of California has created a standardized HIPAA Limited Data Set, The UC COVID Research Data Set (UC CORDS) designed for research purposes, contains clinical and inpatient information of the patients tested for SARS-CoV-2 infection across UC Health. The rapid-query model is a multi-step framework comprising a computational pipeline to rapidly query the data warehouse and refine the question further with a follow-up statistical analysis. UC-Health proposes to deliver preliminary answers within 2-4 days of the questions being transmitted, and more determinant answers within two weeks of the final refined question. Answers are delivered in regular reports accompanied by tables of counts and data visualizations.
Results
The collaboration has developed processes for implementing the rapid-query model, including outcome measures. Questions are prioritized for consideration by a team led by FDA’s Principal Deputy Commissioner.
Conclusions
This project meets the regulatory science objective of development of methods and tools to improve and streamline clinical and post-marketing evaluation of FDA-regulated products. Results from this project will inform FDA’s utilization of RWD data sources for efficient decision-making. The rapid-query model initiated between the US-FDA and UC-Health will enable real-world evidence generation in a statistically rigorous manner to help inform medical and policy level decision making.
