2021 FDA Science Forum
The Food and Drug Administration (FDA-CDER-OMP) COVID-19 Knowledge Bank
- Authors:
- Center:
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
Background:
The COVID-19 pandemic generated large volumes of data and highlighted existing knowledge gaps, creating a pressing need to collate and share a repository of evidence-based information on disease pathophysiology and key insights about FDA’s COVID-19 therapeutic supply chain management activities.
Purpose:
To support real time and rapid comprehension of emerging knowledge consistent with the information age, the Office of Medical Policy (OMP) developed a continuously updated COVID-19 Knowledge Bank (KBANK) to provide FDA staff with access to up to date information on evolving topics during the public health emergency, especially data on critical care drugs needed in mitigating pandemic-related drug supply disruptions and facilitating transparency in supply chain management.
Methodology:
Multiple internal and external information resources were evaluated to facilitate access and analytics of large volume and complex data generated in healthcare, research and regulatory settings relevant to the COVID-19 pandemic, including expert medical consensus treatment guidelines and published professional clinical decision support tools that provided background information on this novel infectious disease. FDA discussions and publicly trending COVID-19 topics were also gathered to summarize relevant, science-based information into rapidly comprehensible presentations. Top-line outputs from real-world data monitoring of critical care drug supply, national and global infection, hospitalization and mortality rates were collated. A framework for facile access to compiled information was established with features enhancing user experience through search functionalities, interactive menus for enhanced maneuverability, and embedded videos.
Results:
The COVID-19 KBANK currently consists of over 1200 slides with topics including i) disease overview, ii) outpatient management, iii) infection control, iv) ventilators, v) pregnancy, vi) pediatrics, vii) inpatient therapeutics, and viii) hand sanitizer ingestion and complications. The KBANK continues to be socialized through CDER-wide outreach, cross-Center communication channels, and working group updates.
Conclusion:
The OMP COVID-19 Knowledge Bank provides emerging, streamlined, organized, and accurate content to FDA staff to bridge knowledge gaps and promote public health preparedness. The system serves as a model to support operational efficiency and excellence, and as a framework for public facing communication channels to provide clear and actionable information for broad dissemination and use by diverse consumer and patient populations.
