Stakeholder Engagement in Paediatric Clinical Trials
Research type
Research Study
Full title
Co-designed Stakeholder Engagement and Feedback Processes for Paediatric Clinical Trials (CoSTEP-PaCT)
IRAS ID
367383
Contact name
Gordon Moran
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
1 years, 7 months, 20 days
Research summary
Inflammatory Bowel Disease (IBD), which includes Crohn’s disease and ulcerative colitis, is a long-term condition affecting many children and young people in the UK. Although new treatments are being developed, children are often underrepresented in clinical research. This means that many medicines used for children are based on evidence from adult studies rather than research specifically designed for paediatric patients. Understanding why families might find it challenging to participate in research is key to improving the planning of future paediatric studies.
This study focuses on children with Crohn’s disease. The aim of this research study is to co-create a compact, realistic feedback and engagement toolkit and supporting materials tailored for paediatric advanced therapy (AT) clinical trial development.
Participants will include children aged 12–17 years diagnosed with Crohn’s disease and their parents or carers. They will be invited to take part in a one-off interview lasting 30-45 minutes, which can be held online via Microsoft Teams or in person at the University of Nottingham.
In the next phase of the study, focus group workshops will bring together children with Crohn’s aged 12-17 years, parents or carers, paediatric IBD clinicians, and trialists. These workshops will work collaboratively to co-create a practical feedback toolkit to help researchers design paediatric advanced therapy trials that are more acceptable to children and their families.
This study is part of a PhD project at the University of Nottingham. The findings aim to improve how paediatric Crohn’s disease clinical trials are designed, making research more patient-centred and ensuring that children and families can actively and meaningfully contribute to the development of new treatments.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
26/YH/0103
Date of REC Opinion
11 Jun 2026
REC opinion
Further Information Favourable Opinion