CC BY-NC-ND 4.0 · Appl Clin Inform 2017; 08(01): 291-305
DOI: 10.4338/ACI-2016-11-RA-0188
Research Article
Schattauer GmbH

Harnessing scientific literature reports for pharmacovigilance

Prototype software analytical tool development and usability testing
Alfred Sorbello
1  US Food and Drug Administration, Office of Translational Sciences, Silver Spring, MD, USA
,
Anna Ripple
2  Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA
,
Joseph Tonning
1  US Food and Drug Administration, Office of Translational Sciences, Silver Spring, MD, USA
,
Monica Munoz
3  US Food and Drug Administration, Office of Surveillance and Epidemiology, Silver Spring, MD, USA
,
Rashedul Hasan
1  US Food and Drug Administration, Office of Translational Sciences, Silver Spring, MD, USA
,
Thomas Ly
1  US Food and Drug Administration, Office of Translational Sciences, Silver Spring, MD, USA
,
Henry Francis
1  US Food and Drug Administration, Office of Translational Sciences, Silver Spring, MD, USA
,
Olivier Bodenreider
2  Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health, Bethesda, MD, USA
› Author Affiliations
Funding We wish to acknowledge financial support from the FDA/CDER/Office of Translational Sciences and the Intramural Research Program, NIH, National Library of Medicine.
Further Information

Publication History

Received: 02 November 2016

Accepted: 14 January 2017

Publication Date:
20 December 2017 (online)

  

Summary

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 regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use.

Results: All usability test participants cited the tool’s ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool’s automated literature search relative to a manual ‘all fields’ PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Conclusions: Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.