Drug Safety

, Volume 40, Issue 5, pp 399–408

Validation of New Signal Detection Methods for Web Query Log Data Compared to Signal Detection Algorithms Used With FAERS

  • Susan Colilla
  • Elad Yom Tov
  • Ling Zhang
  • Marie-Laure Kurzinger
  • Stephanie Tcherny-Lessenot
  • Catherine Penfornis
  • Shang Jen
  • Danny S. Gonzalez
  • Patrick Caubel
  • Susan Welsh
  • Juhaeri Juhaeri
Original Research Article

DOI: 10.1007/s40264-017-0507-4

Cite this article as:
Colilla, S., Tov, E.Y., Zhang, L. et al. Drug Saf (2017) 40: 399. doi:10.1007/s40264-017-0507-4

Abstract

Introduction

Post-marketing drug surveillance is largely based on signals found in spontaneous reports from patients and healthcare providers. Rare adverse drug reactions and adverse events (AEs) that may develop after long-term exposure to a drug or from drug interactions may be missed. The US FDA and others have proposed that web-based data could be mined as a resource to detect latent signals associated with adverse drug reactions.

Methods

Recently, a web-based search query method called a query log reaction score (QLRS) was developed to detect whether AEs associated with certain drugs could be found from search engine query data. In this study, we compare the performance of two other algorithms, the proportional query ratio (PQR) and the proportional query rate ratio (Q-PRR) against that of two reference signal-detection algorithms (SDAs) commonly used with the FDA AE Reporting System (FAERS) database.

Results

In summary, the web query methods have moderate sensitivity (80%) in detecting signals in web query data compared with reference SDAs in FAERS when the web query data are filtered, but the query metrics generate many false-positives and have low specificity compared with reference SDAs in FAERS.

Conclusion

Future research is needed to find better refinements of query data and/or the metrics to improve the specificity of these web query log algorithms.

Supplementary material

40264_2017_507_MOESM1_ESM.docx (103 kb)
Supplementary material 1 (DOCX 102 kb)

Funding information

Funder NameGrant NumberFunding Note
Sanofi

    Copyright information

    © Springer International Publishing Switzerland 2017

    Authors and Affiliations

    • Susan Colilla
      • 1
    • Elad Yom Tov
      • 2
    • Ling Zhang
      • 1
    • Marie-Laure Kurzinger
      • 3
    • Stephanie Tcherny-Lessenot
      • 3
    • Catherine Penfornis
      • 3
    • Shang Jen
      • 4
    • Danny S. Gonzalez
      • 5
    • Patrick Caubel
      • 6
    • Susan Welsh
      • 1
    • Juhaeri Juhaeri
      • 1
    1. 1.PharmacoepidemiologyGlobal Safety Sciences, SanofiBridgewaterUSA
    2. 2.Microsoft ResearchHerzeliyaIsrael
    3. 3.Pharmacoepidemiology & Signal Detection, Global Safety SciencesSanofiChilly-MazarinFrance
    4. 4.Baxalta US, Inc., Global Drug SafetyCambridgeUSA
    5. 5.US Food and Drug AdministrationSilver SpringUSA
    6. 6.Pfizer, Worldwide SafetyNew YorkUSA

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