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Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project

Author

Listed:
  • Jonathan L. Richardson

    (Newcastle upon Tyne Hospitals NHS Foundation Trust
    Newcastle University)

  • Alan Moore

    (Novartis Pharma AG)

  • Rebecca L. Bromley

    (University of Manchester
    Royal Manchester Children’s Hospital)

  • Michael Stellfeld

    (Novo Nordisk A/S)

  • Yvonne Geissbühler

    (Novartis Pharma AG)

  • Matthew Bluett-Duncan

    (University of Manchester)

  • Ursula Winterfeld

    (University Hospital)

  • Guillaume Favre

    (University Hospital)

  • Amalia Alexe

    (Novartis Pharma AG)

  • Alison M. Oliver

    (Newcastle upon Tyne Hospitals NHS Foundation Trust)

  • Yrea R. J. Rijt-Weetink

    (Pharmacovigilance Centre Lareb)

  • Kenneth K. Hodson

    (Newcastle upon Tyne Hospitals NHS Foundation Trust)

  • Bita Rezaallah

    (Novartis Pharma AG)

  • Eugene P. Puijenbroek

    (Pharmacovigilance Centre Lareb
    University of Groningen)

  • David J. Lewis

    (Novartis Pharma GmbH
    University of Hertfordshire)

  • Laura M. Yates

    (University of KwaZulu-Natal
    Newcastle upon Tyne Hospitals NHS Foundation Trust)

Abstract

Introduction and Objective The risks and benefits of medication use in pregnancy are typically established through post-marketing observational studies. As there is currently no standardised or systematic approach to the post-marketing assessment of medication safety in pregnancy, data generated through pregnancy pharmacovigilance (PregPV) research can be heterogenous and difficult to interpret. The aim of this article is to describe the development of a reference framework of core data elements (CDEs) for collection in primary source PregPV studies that can be used to standardise data collection procedures and, thereby, improve data harmonisation and evidence synthesis capabilities. Methods This CDE reference framework was developed within the Innovative Medicines Initiative (IMI) ConcePTION project by experts in pharmacovigilance, pharmacoepidemiology, medical statistics, risk–benefit communication, clinical teratology, reproductive toxicology, genetics, obstetrics, paediatrics, and child psychology. The framework was produced through a scoping review of data collection systems used by established PregPV datasets, followed by extensive discussion and debate around the value, definition, and derivation of each data item identified from these systems. Results The finalised listing of CDEs comprises 98 individual data elements, arranged into 14 tables of related fields. These data elements are openly available on the European Network of Teratology Information Services (ENTIS) website ( http://www.entis-org.eu/cde ). Discussion With this set of recommendations, we aim to standardise PregPV primary source data collection processes to improve the speed at which high-quality evidence-based statements can be provided about the safety of medication use in pregnancy.

Suggested Citation

  • Jonathan L. Richardson & Alan Moore & Rebecca L. Bromley & Michael Stellfeld & Yvonne Geissbühler & Matthew Bluett-Duncan & Ursula Winterfeld & Guillaume Favre & Amalia Alexe & Alison M. Oliver & Yrea, 2023. "Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project," Drug Safety, Springer, vol. 46(5), pages 479-491, May.
  • Handle: RePEc:spr:drugsa:v:46:y:2023:i:5:d:10.1007_s40264-023-01291-7
    DOI: 10.1007/s40264-023-01291-7
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    References listed on IDEAS

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    1. R. A. Charlton & A. McGrogan & J. Snowball & L. M. Yates & A. Wood & J. Clayton-Smith & W. H. Smithson & J. L. Richardson & N. McHugh & S. H. L. Thomas & G. A. Baker & R. Bromley, 2017. "Sensitivity of the UK Clinical Practice Research Datalink to Detect Neurodevelopmental Effects of Medicine Exposure in Utero: Comparative Analysis of an Antiepileptic Drug-Exposed Cohort," Drug Safety, Springer, vol. 40(5), pages 387-397, May.
    2. Saskia Vorstenbosch & Bernke Winkel & Marleen M. H. J Gelder & Agnes Kant & Nel Roeleveld & Eugène Puijenbroek, 2019. "Aim and Design of pREGnant, the Dutch Pregnancy Drug Register," Drug Safety, Springer, vol. 42(1), pages 1-12, January.
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