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Journal of Clinical and Experimental Reproductive Medicine

ISSN: 3067-7904

Commentary Open Access
Volume 2 | Issue 1 | DOI: https://doi.org/10.46439/reproductivemed.2.007

Improving data harmonization in pregnancy safety studies: Demonstrating the feasibility of standardized data analysis of pregnancy reports–A contribution from the conception project

Ursula Winterfeld1,*, Guillaume Favre1,2, Jonathan Luke Richardson3,4, Alan Moore5, Yvonne Geissbühler5, Valentine Jehl5, Alison Oliver3, Svetlana Shechtman6, Orna Diav-Citrin6, Maya Berlin7, Tal De Haan7, David Baud2, Alice Panchaud8,9, Anil Mor10, Meritxell Sabido11, Sabrina de Souza11, Christina Chambers12, Eugène P van Puijenbroek13,17, Laura M Yates14,15, François R Girardin1, Michael Stellfeld16
  • 1Swiss Teratology Information Service and Clinical Pharmacology Service, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
  • 2Materno-fetal and Obstetrics Research Unit, Department
  • 3UK Teratology Information Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom
  • 4Institute of Health and Society, Newcastle upon Tyne, United Kingdom
  • 5Novartis Pharma AG, Basel, Switzerland
  • 6The Israeli Teratology Information Service, Ministry of Health, Jerusalem, Israel
  • 7Clinical Pharmacology and Toxicology Unit, Drug Consultation Center, Shamir Medical Center (Assaf Harofeh), Zerifin TIS, affiliated with the Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  • 8Institute of Primary Health Care (BIHAM), University of Bern, Switzerland
  • 9Service of Pharmacy, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
  • 10Sanofi, Bridgewater, USA
  • 11Merck Healthcare KGaA, Darmstadt, Germany
  • 12University of California San Diego, and Organization of Teratology Information Specialists (OTIS)
  • 13Pharmacovigilance Centre Lareb,’s-Hertogenbosch, the Netherlands
  • 14Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, UK
  • 15KRISP, University of KwaZulu-Natal, South Africa
  • 16Novo Nordisk A/S, Søborg, Denmark
  • 17University of Groningen, Groningen Research Institute of Pharmacy, PharmacoTherapy, - Epidemiology & -Economics, Groningen, The Netherlands
+ Affiliations - Affiliations

Corresponding Author

Ursula Winterfeld, ursula.winterfeld@chuv.ch

Received Date: January 21, 2025

Accepted Date: March 28, 2025

Citation:

Winterfeld U, Favre G, Richardson JL, Moore A, Geissbühler Y, Jehl V, et al. Improving data harmonization in pregnancy safety studies: Demonstrating the feasibility of standardized data analysis of pregnancy reports–A contribution from the conception project. J Clin Exp Reprod Med. 2025;2(1):6-12.


Copyright: © 2025 Winterfeld U, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Introduction: Aligned with the Innovative Medicines Initiative (IMI) ConcePTION project’s goal of advancing drug safety research in pregnancy, we explored the feasibility of employing a standardized list of core data elements (CDEs) and statistical outputs to harmonize data collection and analysis across various study partners. 
Methods: Study partners from public research institutions and pharmaceutical companies extracted pregnancy safety data on disease-modifying therapies for multiple sclerosis from their databases, mapped them to the CDE framework, and analysed datasets using a common statistical analysis plan (SAP). Questionnaires were used to gather contextual information on data collection practices, including data definitions and infant follow-up, and to evaluate the feasibility and practicality of the proposed methodology.
Results: The study demonstrated the feasibility of harmonizing pregnancy safety data using standardized CDEs and a common SAP. All six study partners successfully mapped their data into the CDE framework and produced standardized outputs. Challenges were identified in aligning with recommended definitions, such as classifying ‘prospective cases’ based on differing criteria—pregnancies reported while ongoing, before fetal malformation diagnosis, or before any prenatal screening—and categorizing congenital anomalies using the EUROCAT system. The feasibility questionnaires revealed strong support for the methodology, with all six study partners reporting access to the necessary expertise and all six finding the statistical guidance easy to follow. 
Conclusions: This study demonstrates the feasibility of employing standardized CDEs and a common SAP to describe pregnancy exposure and outcome data across diverse data providers. The methodology shows promise for improving consistency in pregnancy safety research but requires addressing challenges such as resource constraints and variability in data collection for broader adoption. 

Keywords

Feasibility, Pregnancy pharmacovigilance, Teratogen surveillance, Medicines, Pregnancy

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