From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Abstract

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project-Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation-with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and motherchild linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population.

Myocarditis and pericarditis associated with SARS-CoV-2 vaccines: A population-based descriptive cohort and a nested self-controlled risk interval study using electronic health care data from four European countries

“…All five data sources converted their local data to the Conception common data model (Thurin et al, 2022) resulting in structurally harmonised local datasets that were Frontiers in Pharmacology frontiersin.org quality checked (Hoxhaj, 2022a;van den Bor, 2022;Hoxhaj, 2022b). Analyses were performed locally, and the aggregated output was uploaded to a Digital Research Environment for standardisation and meta-analysis.…”

Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework

“…In Europe, the ConcePTION consortium, begun in 2019, included 20 experts in complementary fields from 10 countries to select, identify and define core evidence elements to assess safety in pregnancy, followed by a stakeholder consultation with external experts [ 24 ]. The report includes core outcome data elements and addresses measurement of maternal exposure and the aetiological window for each outcome, confounders, study designs, analytical considerations, statistical power and quality assessment [ 25 ]; the European Health Data and Evidence Network is supporting adoption of the ConcePTION Common Data Model across Europe to create a federated network of data systems [ 26 ].…”

Time to Treatment Intensification in Patients Receiving DPP4 Inhibitors Versus Sulfonylureas as the First Add-On to Metformin Monotherapy: A Retrospective Cohort Study

“…This study was based on the analysis of data from four Italian regions, Piedmont (northern Italy), Tuscany and Umbria (central Italy), and one LHA, Caserta (southern Italy) covering an overall source population of around 10 million people ( http://demo.istat.it/bil2015/index.html ). The four data sources are based on different data banks ( Thurin et al, 2021 ), which collect person-level information on the utilization of healthcare services reimbursed by the National Healthcare Service (NHS) and dispensed to any subject who is resident and registered with a general practitioner in the relevant catchment areas. Through a pseudoanonymized identification code, patient-level information recorded in different registries can be linked.…”