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

Lucia Ruggieri1, Adriana Ceci1, Franco Bartoloni1

  • 1Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, Via Abate Eustasio 30, 70100, Valenzano, BA, Italy.

Contemporary Clinical Trials Communications
|March 5, 2021
PubMed

Insights

The PedCRIN project identified key infrastructural support needs for paediatric clinical research, particularly in innovative study design and funding applications. Addressing these gaps will significantly benefit the pediatric research community.

Area of Science:

  • Clinical Research Infrastructure
  • Paediatric and Neonatal Trials

Background:

  • The European Clinical Research Infrastructure Network (ECRIN) project aimed to establish a paediatric component (PedCRIN).
  • Paediatric clinical research faces specific challenges requiring tailored infrastructural support.

Purpose of the Study:

  • To identify and assess the infrastructural support needs of stakeholders in paediatric clinical research.
  • To inform the development of tools for conducting neonatal and paediatric trials.

Main Methods:

  • A cross-sectional, closed-ended electronic questionnaire was distributed to paediatric clinical research stakeholders.
  • 147 responses were collected and analyzed using a Likert-scale evaluation.

Main Results:

  • High support needs were reported for innovative study design (123 respondents) and protocol preparation (117 respondents).
  • Funding identification and application support was also highly requested (123 respondents).
  • Respondents outside Paediatric Research Networks/Consortia showed significantly higher needs for regulatory, pharmacovigilance, and GCP training.

Conclusions:

  • The findings highlight critical areas where infrastructural support is essential for advancing paediatric research.
  • Achieving PedCRIN's objectives is crucial for enhancing the paediatric research community's capabilities.

Keywords:
Clinical trials networkPaediatricResearch infrastructureResearch needSurvey

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