Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.

ABSTRACT:

Objectives

We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool.

Methods

A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regu

SUBMITTER: Sorbello A 

PROVIDER: S-EPMC5373771 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature