Better medicine safety for pregnant women and breastfeeding mothers
Researchers supported by the EU- and industry-funded ConcePTION project are helping to reduce uncertainty about the safety of medicines used by expectant and breastfeeding mothers. Their new study contributes to the development of a system that can transform existing healthcare data into evidence in a robust and transparent way. This will help to answer questions about medicine use, effectiveness and safety during pregnancy and breastfeeding. Published in the journal ‘Clinical Pharmacology & Therapeutics’, the study introduces a set of concepts to represent heterogeneity across 21 European data sources. It also describes the common data model (CDM) designed as part of the project to manage the heterogeneity of Europe’s diverse databanks. The ConcePTION CDM serves as the keystone of the federated ConcePTION network.
Managing heterogeneous data sources
“This capacity to align very heterogeneous sources and to preserve their levels of detail allows leveraging of specific records, such as those relating to pregnancy, which are challenging to explore in distributed approaches,” the authors report in the study. “In this context, technical choices may have profound consequences on the evidence generated. For example, information about the start of a pregnancy may be captured with different types of records across data banks—date of last menstrual period, or gestational age in weeks, or gestational age in days—and all of those slightly different data items have to be treated in a specific way to enable the estimation of an accurate date. At the same time, having this heterogeneity represented in a CDM allows source-specific data processing to be performed by a common program, which enhances transparency and reproducibility.” The ConcePTION CDM captures routine healthcare, public health surveillance and population data, as well as metadata that is stored in structured tables in databanks across Europe. So far, it has made it possible for at least 13 data sources to run common scripts – lines of computer code enabling data capture – to contribute to major European projects. This highlights the tool’s potential to address questions about medicine use, effectiveness and safety not only in pregnant women and breastfeeding mothers but also more broadly, in the general population. “Many women are concerned about the safety of medicines taken during pregnancy and while breastfeeding, and information is not always available,” notes study co-author Prof. Sue Jordan of ConcePTION project partner Swansea University, United Kingdom, in a news item posted on the university’s website. “Databanks across Europe are working together to address this problem by exploring the benefits and harms to both women and children when medicines are prescribed during these critical periods. Our group is very pleased to contribute to the influential ENCePP guide on research methods.” With the ConcePTION CDM, approved researchers and data scientists can securely access captured data within each databank for linkage and analysis. Analysis results are then pooled at Dutch project coordinator University Medical Center Utrecht, enabling a Europe-wide examination. Thanks to this federated approach, data remains well protected by each databank’s governance and data access protocols. The project aims to create a trusted ecosystem that can generate reliable evidence on the effects of medications used during pregnancy and breastfeeding for women and their healthcare providers. ConcePTION (Building an ecosystem for better monitoring and communicating of medication safety in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation) is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry. For more information, please see: ConcePTION project website
Keywords
ConcePTION, medicine, medication, pregnancy, breastfeeding, common data model
