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

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 thr...

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Published in:Drug safety 2023-05, Vol.46 (5), p.479-491
Main Authors: Richardson, Jonathan L., Moore, Alan, Bromley, Rebecca L., Stellfeld, Michael, Geissbühler, Yvonne, Bluett-Duncan, Matthew, Winterfeld, Ursula, Favre, Guillaume, Alexe, Amalia, Oliver, Alison M., van Rijt-Weetink, Yrea R. J., Hodson, Kenneth K., Rezaallah, Bita, van Puijenbroek, Eugene P., Lewis, David J., Yates, Laura M.
Format: Article
Language:English
Subjects:
Breastfeeding & lactation
Data collection
Datasets
Dictionaries
Drug Safety and Pharmacovigilance
Genetics
Information services
Marketing
Medical statistics
Medicine
Medicine & Public Health
Obstetrics
Original
Original Research Article
Pediatrics
Pharmaceutical industry
Pharmacology/Toxicology
Pharmacovigilance
Pregnancy
Risk communication
Safety
Surveillance
Toxicology
Websites
Womens health
Working groups
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Summary: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.
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-023-01291-7