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Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe-wide trials.

Authors
  • Ruggieri, Lucia1
  • Bonifazi, Donato2
  • Landi, Annalisa1
  • Bonifazi, Fedele1
  • Bartoloni, Franco1
  • Costello, Mary3
  • Felisi, Maria Grazia2
  • Gasthuys, Elke4
  • Godo, Anila5
  • Martinon Torres, Federico6
  • Nadal, David7
  • Nuytinck, Lieve4
  • Rocchi, Francesca8
  • Turner, Mark9
  • Ceci, Adriana1
  • 1 Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Bari, Italy. , (Italy)
  • 2 Consorzio per Valutazioni Biologiche e Farmacologiche, Bari, Italy. , (Italy)
  • 3 National Children's Research Centre, Our Lady's Children's Hospital Crumlin, Dublin, Ireland. , (Ireland)
  • 4 Ghent University, Ghent, Belgium. , (Belgium)
  • 5 University Hospital Center Mother Teresa, Tirana, Albania. , (Albania)
  • 6 Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain. , (Spain)
  • 7 University of Zurich, Zurich, Switzerland. , (Switzerland)
  • 8 Ospedale Pediatrico Bambino Gesù, Rome, Italy. , (Italy)
  • 9 University of Liverpool, Liverpool, UK.
Type
Published Article
Journal
Acta Paediatrica
Publisher
Wiley (Blackwell Publishing)
Publication Date
Sep 18, 2019
Identifiers
DOI: 10.1111/apa.15020
PMID: 31532836
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The European Network of Excellence for Paediatric Clinical Research, known as the TEDDY Network, carried out a survey to determine the capacity and competence of paediatric centres to perform research studies. A cross-sectional, web-based pilot survey was conducted from October 2016 to April 2017 with paediatric clinical research centres in 11 countries: Albania, Austria, Belgium, Denmark, Iceland, Ireland, Italy, Norway, Spain, Switzerland and the United Kingdom. All were registered with the TEDDY Network database. We approached 107 centres and 63 provided data on their experiences and expertise in paediatric clinical trials. Four groups of performance indicators were identified, referring to scientific experience, trial readiness, trial competence, regulatory issues, ethics and patients. Most centres were actively involved in paediatric clinical research: 53 centres (84.1%) had received funds for more than five paediatric studies in the last 5 years, and 42 (66.7%) had a specific clinical trial unit and dedicated study coordinators. We concluded that the European centres we studied had the capability and capacity to conduct paediatric trials, but there was still room for improvement, including enhanced collaboration. This pilot survey demonstrated that there is potential for performing paediatric trials across Europe, but improvements are possible. © 2019 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

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