Literature DB >> 31532836

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

Lucia Ruggieri1, Donato Bonifazi2, Annalisa Landi1, Fedele Bonifazi1, Franco Bartoloni1, Mary Costello3, Maria Grazia Felisi2, Elke Gasthuys4, Anila Godo5, Federico Martinon Torres6, David Nadal7, Lieve Nuytinck4, Francesca Rocchi8, Mark Turner9, Adriana Ceci1.   

Abstract

AIM: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.

Entities:  

Keywords:  Europe; capacity; clinical research; competence; paediatric trials

Mesh:

Year:  2019        PMID: 31532836     DOI: 10.1111/apa.15020

Source DB:  PubMed          Journal:  Acta Paediatr        ISSN: 0803-5253            Impact factor:   2.299


  2 in total

1.  Paediatric clinical research in Europe: an insight on experts' needs and perspectives.

Authors:  Lucia Ruggieri; Adriana Ceci; Franco Bartoloni; Valèry Elie; Mariagrazia Felisi; Evelyne Jacqz-Aigrain; Mariangela Lupo; Salma Malik; Cristina Manfredi; Giorgio Reggiardo; Jacques Demotes; Donato Bonifazi
Journal:  Contemp Clin Trials Commun       Date:  2021-02-10

Review 2.  European research networks to facilitate drug research in children.

Authors:  Mark A Turner; Katharine Cheng; Saskia de Wildt; Heidrun Hildebrand; Sabah Attar; Paolo Rossi; Donato Bonifazi; Adriana Ceci; Joana Claverol; Begonya Nafria; Carlo Giaquinto
Journal:  Br J Clin Pharmacol       Date:  2020-09-20       Impact factor: 3.716

  2 in total

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