2023 FDA Science Forum
Developing Web Applications for Expedited Risk Assessment at the FDA
- Authors:
- Center:
-
Contributing OfficeCenter for Biologics Evaluation and Research
Abstract
A major challenge for the FDA Center for Biologics Evaluation and Research (CBER) is evaluating and responding quickly to the risk of emerging transfusion-transmitted diseases that may impact the blood supply. When a new transfusion-transmitted disease emerges, detailed information about the disease is often limited, scattered across myriad sources, which complicates risk evaluation for regulatory decision-making. CBER’s Office of Biostatistics and Pharmacovigilance (OBPV) created two decision support tools: GIS-based Risk Evaluation and Assessment Tool (GREAT) web application, which provides geographic risk information, and Blood Risk (BRisk) Tool, which performs risk assessment using probabilistic algorithms in predetermined models. These tools were developed as web applications on the FDA OIMT Innovation Lab Sandbox and have been deployed to the FDA’s Amazon Web Services (AWS) GovCloud West organization. GREAT integrates and visualizes disease-related geographic information, generates geographic risk ranking maps, estimates geographic risk contribution and ranks geographic risks. Once the potential regions of interest are identified, BRisk can be used to update models for running simulations of how potential interventions would impact the risk of disease transmission through blood transfusions and the potential donor loss. The AWS-based tools provide decision-makers with information concerning identified threats and possible mitigations and assist in the development and evaluation of emerging donor deferral and blood screening policies. These applications utilize AWS to take advantage of the flexibility and scalability the cloud provides.
