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Expert consensus on neurodevelopmental outcomes in pregnancy pharmacovigilance studies

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Last modified
  • 06/25/2025
Type of Material
Authors
    RL Bromley, University of ManchesterM Bickle Graz, Lausanne University HospitalM Bluett-Duncan, University of ManchesterC Chambers, University of California San DiegoP Damkier, University of Southern DenmarkK Dietrich, University of CincinnatiH Dolk, Ulster UniversityK Grant, University of Washington, SeattleS Mattson, San Diego State UniversityKJ Meador, Stanford UniversityH Nordeng, University of OsloTF Oberlander, University of British ColumbiaA Ornoy, Ariel UniversityA Revet, INSERM University of ToulouseJ Richardson, UK Teratology Information ServiceJ Rovet, University of TorontoL Schuler-Faccini, Universidade Federal Do Rio Grande Do SulE Smearman, Emory UniversityV Simms, Ulster UniversityC Vorhees, University of CincinnatiK Wide, Karolinska University HospitalA Wood, Murdoch Children’s Research InstituteL Yates, Newcastle Upon Tyne Hospitals NHS Foundation TrustE Ystrom, Norwegian Institute of Public HealthTA Supraja, National Institute of Mental Health and Neurosciences NIMHANS, BangaloreJ Adams, University of Massachusetts Boston
Language
  • English
Date
  • 2023-06-01
Publisher
  • Frontiers Media
Publication Version
Copyright Statement
  • © 2023 Bromley, Bickle Graz, Bluett-Duncan, Chambers, Damkier, Dietrich, Dolk, Grant, Mattson, Meador, Nordeng, Oberlander, Ornoy, Revet, Richardson, Rovet, Schuler-Faccini, Smearman, Simms, Vorhees, Wide, Wood, Yates, Ystrom, Supraja and Adams.
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Final Published Version (URL)
Title of Journal or Parent Work
Volume
  • 14
Grant/Funding Information
  • This work has been completed as part of the ConcePTION study. 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.
Supplemental Material (URL)
Abstract
  • Background: Exposure in utero to certain medications can disrupt processes of fetal development, including brain development, leading to a continuum of neurodevelopmental difficulties. Recognizing the deficiency of neurodevelopmental investigations within pregnancy pharmacovigilance, an international Neurodevelopmental Expert Working Group was convened to achieve consensus regarding the core neurodevelopmental outcomes, optimization of methodological approaches and barriers to conducting pregnancy pharmacovigilance studies with neurodevelopmental outcomes. Methods: A modified Delphi study was undertaken based on stakeholder and expert input. Stakeholders (patient, pharmaceutical, academic and regulatory) were invited to define topics, pertaining to neurodevelopmental investigations in medication-exposed pregnancies. Experts were identified for their experience regarding neurodevelopmental outcomes following medicinal, substances of misuse or environmental exposures in utero. Two questionnaire rounds and a virtual discussion meeting were used to explore expert opinion on the topics identified by the stakeholders. Results: Twenty-five experts, from 13 countries and professionally diverse backgrounds took part in the development of 11 recommendations. The recommendations focus on the importance of neurodevelopment as a core feature of pregnancy pharmacovigilance, the timing of study initiation and a core set of distinct but interrelated neurodevelopmental skills or diagnoses which require investigation. Studies should start in infancy with an extended period of investigation into adolescence, with more frequent sampling during rapid periods of development. Additionally, recommendations are made regarding optimal approach to neurodevelopmental outcome measurement, comparator groups, exposure factors, a core set of confounding and mediating variables, attrition, reporting of results and the required improvements in funding for potential later emerging effects. Different study designs will be required depending on the specific neurodevelopmental outcome type under investigation and whether the medicine in question is newly approved or already in widespread use. Conclusion: An improved focus on neurodevelopmental outcomes is required within pregnancy pharmacovigilance. These expert recommendations should be met across a complementary set of studies which converge to form a comprehensive set of evidence regarding neurodevelopmental outcomes in pregnancy pharmacovigilance.
Author Notes
Keywords
Research Categories
  • Health Sciences, Pharmacology
  • Psychology, General
  • Environmental Sciences
  • Biology, Neuroscience

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