c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper
Aurich B, Apele-Freimane D, Banaschewski T, Chouchana L, Day S, Kaguelidou F, Kelly LE, Kindblom JM, Neubert A, Wong ICK (2021)
Publication Type: Journal article, Review article
Publication year: 2021
Journal
DOI: 10.1111/bcp.15119
Abstract
Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population-specific factors (e.g., more frequent use of off-label/unlicensed drugs). In recognition of these challenges, a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life-cycle of medicinal products which are described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development, safety data collection and analysis. Furthermore, they describe the specific details of post-marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record-linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit-risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life-cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs.
Authors with CRIS profile
Involved external institutions
Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal
France (FR)
Pauls Stradiņš Clinical University Hospital / Paula Stradiņa Klīniskā universitātes slimnīca
Latvia (LV)
Ruprecht-Karls-Universität Heidelberg
Germany (DE)
University of Paris 4 - Paris-Sorbonne / Université paris IV Paris-Sorbonne
France (FR)
Clinical Trials Consulting & Training Limited
United Kingdom (GB)
University of Manitoba
Canada (CA)
Sahlgrenska University Hospital / Sahlgrenska Universitetssjukhuset
Sweden (SE)
University of Hong Kong (HKU) / 香港大學
Hong Kong (HK)
France (FR)
Pauls Stradiņš Clinical University Hospital / Paula Stradiņa Klīniskā universitātes slimnīca
Latvia (LV)
Ruprecht-Karls-Universität Heidelberg
Germany (DE)
University of Paris 4 - Paris-Sorbonne / Université paris IV Paris-Sorbonne
France (FR)
Clinical Trials Consulting & Training Limited
United Kingdom (GB)
University of Manitoba
Canada (CA)
Sahlgrenska University Hospital / Sahlgrenska Universitetssjukhuset
Sweden (SE)
University of Hong Kong (HKU) / 香港大學
Hong Kong (HK)
How to cite
APA:
Aurich, B., Apele-Freimane, D., Banaschewski, T., Chouchana, L., Day, S., Kaguelidou, F.,... Wong, I.C.K. (2021). c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper. British Journal of Clinical Pharmacology. https://dx.doi.org/10.1111/bcp.15119
MLA:
Aurich, Beate, et al. "c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper." British Journal of Clinical Pharmacology (2021).
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