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. 2022 Jan;111(1):321-331.
doi: 10.1002/cpt.2476. Epub 2021 Nov 26.

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

Nicolas H Thurin  1 , Romin Pajouheshnia  2 , Giuseppe Roberto  3 , Caitlin Dodd  4 , Giulia Hyeraci  3 , Claudia Bartolini  3 , Olga Paoletti  3 , Hedvig Nordeng  4 , Helle Wallach-Kildemoes  4 , Vera Ehrenstein  5 , Elena Dudukina  5 , Thomas MacDonald  6 , Giorgia De Paoli  6 , Maria Loane  7 , Christine Damase-Michel  8 , Anna-Belle Beau  8 , Cécile Droz-Perroteau  1 , Régis Lassalle  1 , Jorieke Bergman  9 , Karin Swart  10 , Tania Schink  11 , Clara Cavero-Carbonell  12 , Laia Barrachina-Bonet  12 , Ainhoa Gomez-Lumbreras  13 , Maria Giner-Soriano  13 , María Aragón  13 , Amanda J Neville  14 , Aurora Puccini  15 , Anna Pierini  16 , Valentina Ientile  17 , Gianluca Trifirò  18 , Anke Rissmann  19 , Maarit K Leinonen  20 , Visa Martikainen  20 , Sue Jordan  21 , Daniel Thayer  21 , Ieuan Scanlon  21 , Mary E Georgiou  22 , Marianne Cunnington  22 , Morris Swertz  9 , Miriam Sturkenboom  23 , Rosa Gini  3
Affiliations

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

Nicolas H Thurin et al. Clin Pharmacol Ther. 2022 Jan.

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 mother-child 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.

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Conflict of interest statement

N.H.T., C.D.‐P., and R.L. are researchers at Bordeaux PharmacoEpi, an independent research platform of the Bordeaux University and its subsidiary the ADERA SAS, which performs financially supported studies for public and private partners. G.R., G.H., C.B., O.P., and R.G. are employed by ARS, a public health agency that conducts or participates in pharmacoepidemiology studies compliant with the ENCePP Code of Conduct. The budget of ARS is partially sustained by such studies. R.P. received funding for two projects under EMA contract EMA/2017/09/PE/04, which makes use of the ConcePTION common data model and other materials described in this manuscript. V.E. and E.D. are salaried employees by the Department of Clinical Epidemiology, Aarhus University, which is involved in studies with institutional funding from regulators and from various pharmaceutical companies, as research grants to and administered by Aarhus University. None of these studies is related to the current study. T.M.D. has received funding from UK NIHR and previously from Menarini, as well as consultancy fees from Astra Zeneca. K.S. is an employee of the PHARMO Institute for Drug Outcomes Research. This independent research institute performs financially supported studies for government and related healthcare authorities and several pharmaceutical companies. T.S. is an employee of the Leibniz Institute for Prevention Research and Epidemiology – BIPS, an independent, non‐profit research institute, which performs among others financially supported studies for government and related healthcare authorities and pharmaceutical companies. A.G.‐L., M.G.‐S., and M.A. are employees of IDIAPJGol. They are working on other projects funded by pharmaceutical companies in the institution, which are not related to this study and with no personal profit. G.T. has been involved in advisory boards and has received research grants from public and private partners, which are not related to the topic of this paper. M.E.G. and M.C. are employees of, and hold shares in GSK. M.S. has been the principal investigator on an EMA requested post‐authorization safety study (Novartis) not related to the topic, and has received research grant and pending grants. All other co‐authors declared no competing interests for this work.

Figures

Figure 1
Figure 1
Data banks in each data source. Only data banks included in at least two data sources are represented, the others are summarized in “Other.” The data banks are described in Table 2.
Figure 2
Figure 2
ConcePTION CDM version 2.2. Solid black lines refer to the linkage across records of the same person; dotted lines refer to linkage across items extracted from the same record; solid grey lines refer to linkage from items referring to a medicinal product to the product itself. Tables are color coded according to the section of the common data model they belong to: Routine healthcare data are represented in green, Surveillance data in dark blue, Curated data in light blue, and Metadata in grey. CDM, Common Data Model; ETL, Extract, Transform and Load.
Figure 3
Figure 3
Example of Entity‐Attribute‐Value structure. The data contained in the upper table is represented in the lower table as an Entity Attribute Value fashion. Person_id is the Entity; HEIGHT, WEIGHT, and GESTAGE_WEEKS are the Attributes; and, for instance, 169 is the Value of Attribute HEIGHT for Entity P1.
Figure 4
Figure 4
Common ETL between original families of data banks and tables of the ConcePTION CDM version 2.2. In the Figure, each arrow represents a pair formed by an original family of data bank and a ConcePTION CDM target table. CDM, Common Data Model.
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