From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
Thurin, Nicolas H; Pajouheshnia, Romin; Roberto, Giuseppe; Dodd, Caitlin; Hyeraci, Giulia; Bartolini, Claudia; Paoletti, Olga; Nordeng, Hedvig; Wallach-Kildemoes, Helle; Ehrenstein, Vera; Dudukina, Elena; MacDonald, Thomas; De Paoli, Giorgia; Loane, Maria; Damase-Michel, Christine; Beau, Anna-Belle; Droz-Perroteau, Cécile; Lassalle, Régis; Bergman, Jorieke; Swart, Karin; Schink, Tania; Cavero-Carbonell, Clara; Barrachina-Bonet, Laia; Gomez-Lumbreras, Ainhoa; Giner-Soriano, Maria; Aragón, María; Neville, Amanda J; Puccini, Aurora; Pierini, Anna; Ientile, Valentina; Trifirò, Gianluca; Rissmann, Anke; Leinonen, Maarit K; Martikainen, Visa; Jordan, Sue; Thayer, Daniel; Scanlon, Ieuan; Georgiou, Mary E; Cunnington, Marianne; Swertz, Morris; Sturkenboom, Miriam; Gini, Rosa
(2022) Clinical Pharmacology and Therapeutics, volume 111, issue 1, pp. 321 - 331
(Article)
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
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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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Keywords: Risk, Pharmacology (medical), Pharmacology
ISSN: 0009-9236
Publisher: Nature Publishing Group
Note: Funding Information: The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 821520. This Joint Undertaking receives support from the European Union?s Horizon 2020 research and innovation program and EFPIA. The authors acknowledge John Logie, Miriam Gatt, Janet Sultana, Annarita Armaroli, and Ursula Kirchmayer for their contribution to this paper, and Alice Leblond for her support in the submission process. Funding Information: The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 821520. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA. Funding Information: 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. Publisher Copyright: © 2021 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.
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