200 million women get pregnant each year, most of them use at least one medication during pregnancy, but safety data are lacking! The ConcePTION project is developing an ecosystem to generate robust evidence on medicines safety information in pregnancy and breastfeeding. Because of the diversity of data across many sites and countries, the ConcePTION common data model is an important part of this safety evidence ecosystem. It enables consistent research approaches to be applied to a large number of datasets across Europe. Something that is needed to fill the knowledge gap regarding medicine safety in pregnancy and breastfeeding. The common data model, and how to harmonize data to support knowledge generation on the safety of medicines for pregnant and breastfeeding women, is described in a paper recently published in Clinical Pharmacology & Therapeutics.
“We need to reduce the uncertainty that is currently surrounding medicine safety for pregnant and breastfeeding women. There is a societal obligation to do so and to do it quickly. We have looked at how to preserve, leverage and report on information held within existing European data sources. And how that can support our pharmacoepidemiological analyses of medicine safety in pregnancy and lactation,” says Miriam Sturkenboom, ConcePTION coordinator and one of the authors.
The ConcePTION common data model is an important tool for knowledge generation and a key part of the infrastructure that transforms data into the evidence needed to fill existing knowledge gaps. The common data model was designed based on data availability and content analysis of 21 European data sources. 10 years of experience in building European common data models went into the design of the ConcePTION model. A model that will allow for capturing data from routine healthcare, public health surveillance measures, registers and teratology data.
Within the first few years of ConcePTION, the common data model has already been applied in 13 of the 21 European data sources and allows research study designs and common analytical scripts to be run consistently and efficiently. So far, it has contributed to major EU-projects related to COVID-19 disease, pregnancy or vaccines and facilitates effective and transparent analytics to address questions about utilization, effectiveness, and safety of medicines in particular populations. Among them pregnant and breastfeeding women.
“Our strategy has been to develop a novel generation of a common data model that can preserve the heterogeneity of European data and its details, that can be implemented within time and budget constraints, and that can conduct distributed analyses transparently and efficiently. Our work to achieve this is what we outline in this paper,” Nicolas Thurin, pharmacoepidemiologist at the University of Bordeaux, and another one of the co-authors concludes.
By Anna Holm
Thurin NH, Pajouheshnia R, Roberto G, From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding, Clinical Pharmacology & Therapeutics, First online 26 November 2021