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

Abstract

Introduction and ObjectiveThe risks and benefits of medication use in pregnancy are typically established through postmarketing 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. ResultsThe 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.

Expert consensus on neurodevelopmental outcomes in pregnancy pharmacovigilance studies

“…Therefore, approaches should be undertaken to ensure that these important factors inherent in the medication exposure are included in all PregPV studies. Efforts have been made recently to develop core data elements for both PregPV primary and secondary data collection approaches ( Damase-Michel and Wurst, 2021 ; Richardson et al, 2023 ).…”

An innovative mobile app for the provision of medical information and collection of safety data on exposure to medicines during pregnancy or breastfeeding: An IHI ConcePTION contribution

“…The pregnancy and breastfeeding information exchange app was developed by redesigning and reconfiguring an existing safety-reporting app (Yellow Card/Med Safety app). 15 Questions and fields (developed based on the common data elements proposed by ConcePTION), specific for pregnancy and lactation, 16 were added.…”

Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project

“…Combining and/or comparing research results on medication safety in pregnancy, whether comparing between studies of the same medication or between medications for the same disease, is also complicated by heterogeneity in the identification and the definitions of key data elements [ 4 ]. This heterogeneity impedes the ability to rapidly combine raw data and/or to assimilate the evidence generated from different studies in order to decrease the time taken to provide reliable conclusions about the safety of medication in pregnancy [ 5 ]. These challenges have been identified since the 1990s and remain unresolved [ 6 ].…”

“…A prerequisite would be that data from the various data access providers (DAPs) can be harmonised according to an agreed set of standard rules concerning the structure and content of the data. A reference framework of core data elements (CDEs) recommended for collection of primary data in pregnancy pharmacovigilance or studies investigating foetal safety following maternal medication use during pregnancy was recently developed in the ConcePTION project as a first step in this process [ 5 ]. The aim of the CDE framework is to help optimise and standardise data collection procedures in primary source pregnancy pharmacovigilance studies to improve data harmonisation and evidence synthesis capabilities.…”