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ORIGINAL RESEARCH article

Front. Pediatr.
Sec. Children and Health
Volume 12 - 2024 | doi: 10.3389/fped.2024.1388170
This article is part of the Research Topic Rare Diseases: From Basic Science to Clinical Practice and Public Health View all 8 articles

Partnership of I-ACT for Children (US) and European Pediatric Clinical Trial Networks to facilitate Pediatric Clinical Trials title: pediatric clinical trial facilitation partnership transatlantic

Provisionally accepted
Eva Degraeuwe Eva Degraeuwe 1,2*Collin Hovinga Collin Hovinga 3Annelies De Maré Annelies De Maré 2Ricardo M. Fernandes Ricardo M. Fernandes 4Callie Heaton Callie Heaton 5Lieve Nuytinck Lieve Nuytinck 2Laura Persijn Laura Persijn 2Ann Raes Ann Raes 1,6,7Johan G. Vande Walle Johan G. Vande Walle 8Mark Turner Mark Turner 10,9
  • 1 Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium
  • 2 Ghent University Hospital, Ghent, East Flanders, Belgium
  • 3 Critical Path Institute (C-Path) department Rare Disease, Washington, United States
  • 4 Laboratório de Farmacologia Clínica e Terapêutica, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal
  • 5 I-ACT for Children, Maryland, United States
  • 6 European Rare Kidney Disease Network (ERKNET), Ghent, East Flanders, Belgium
  • 7 Department of Pediatrics, Ghent University Hospital, Ghent, East Flanders, Belgium
  • 8 Ghent University, Ghent, East Flanders, Belgium
  • 9 University of Liverpool, Liverpool, North West England, United Kingdom
  • 10 conect4children Stichting, Utrecht, Netherlands

The final, formatted version of the article will be published soon.

    Case study of a transatlantic partnership between two pediatric clinical trial facilitation networks for both rare and general indications across High Income Countries. Metrics of clinical trial facilitation to improve drug labelling and adequate use in children. Findings showcase shortcoming and improving quality of trial country and site selection. We make the case that for the upcoming increase in pediatric clinical trials, the use of facilitation networks has a considerable positive impact on start-up timelines and success ratio of a pediatric clinical trial.

    Keywords: pediatric, Drug Development, networks, metrics, global

    Received: 19 Feb 2024; Accepted: 03 Oct 2024.

    Copyright: © 2024 Degraeuwe, Hovinga, De Maré, Fernandes, Heaton, Nuytinck, Persijn, Raes, Vande Walle and Turner. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Eva Degraeuwe, Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.