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Information Visualization Platform for Postmarket Surveillance Decision Support.

Jonathan Spiker1, Kory Kreimeyer1, Oanh Dang2

  • 1The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

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|May 24, 2020
PubMed
Summary
This summary is machine-generated.

A new Information Visualization Platform (InfoViP) helps US FDA Safety Evaluators (SEs) integrate and visualize drug safety data. This tool enhances decision-making for postmarket surveillance by processing diverse information sources efficiently.

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Health Informatics
  • Data Visualization

Background:

  • The US Food and Drug Administration (FDA) receives over 2 million postmarket reports annually.
  • Safety Evaluators (SEs) face challenges integrating and analyzing vast amounts of postmarket data alongside external information.
  • Increasing data volume necessitates more efficient solutions for drug safety surveillance and signal detection.

Purpose of the Study:

  • To develop an interactive decision support application for drug safety surveillance.
  • To integrate and visualize information from postmarket reports, product labels, and biomedical literature.
  • To enhance the efficiency of identifying potential safety signals.

Main Methods:

  • Conducted requirements gathering with seven FDA SEs to design the Information Visualization Platform (InfoViP).
  • Developed InfoViP as a web application using infographic design principles, integrating data from FDA Adverse Event Reporting System, DailyMed, and PubMed.
  • Utilized a Python and JavaScript framework with natural language processing for free-text information analysis and time plot generation.

Main Results:

  • The InfoViP prototype was developed based on SEs' workflows and requirements, focusing on automating time-consuming tasks.
  • SEs provided positive feedback on the prototype's functionalities, particularly the visualization of external information and time plot construction.
  • Suggestions from SEs were incorporated into the final version of the InfoViP system.

Conclusions:

  • The InfoViP system provides context-driven interactive visualizations and informatics tools.
  • It assists FDA SEs in synthesizing data from multiple sources for comprehensive case series analyses.
  • The platform aims to improve the efficiency and effectiveness of postmarket drug safety surveillance.