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

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 R. J. Rijt-Weetink, Kenneth K. Hodson, Bita Rezaallah, Eugene P. Puijenbroek, David J. Lewis and Laura M. Yates
Additional contact information
Jonathan L. Richardson: Newcastle upon Tyne Hospitals NHS Foundation Trust
Alan Moore: Novartis Pharma AG
Rebecca L. Bromley: University of Manchester
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
David J. Lewis: Novartis Pharma GmbH
Laura M. Yates: University of KwaZulu-Natal

Drug Safety, 2023, vol. 46, issue 5, No 6, 479-491

Abstract: 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.

Date: 2023
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DOI: 10.1007/s40264-023-01291-7

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