The EXIT EARLY Study (Part 2) V1.0
Research type
Research Study
Full title
The Exit Early Study: Experiences of clinical trials terminating prematurely. Part 2 – A qualitative study exploring how Children and Young People, Parents and Healthcare Professionals have experienced a clinical trial prematurely terminating which has resulted in the abrupt discontinuation of the investigational product.
IRAS ID
289589
Contact name
Helen Pluess-Hall
Contact email
Sponsor organisation
University of Bath
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
The EXIT EARLY study is a multi-part study seeking to answer the research question: What strategies can healthcare professionals delivering clinical research utilize to support paediatric patients and their families when a clinical trial prematurely terminates? This is Part 2, a qualitative study focusing on how children, young people, their parents and healthcare professionals have experienced clinical trials stopping early and the medication or treatment stopping suddenly. In order to design resources for healthcare professionals to appropriately support paediatric research participants and their families in this situation it is important to explore how this group have experienced this situation. This study is investigating the experience of clinical trials ending before they were planned to resulting in abruptly stopping a medication or treatment for children and young people cared for by paediatric services. Participants will be children or young people who have taken part in a clinical trial that prematurely terminated, a parent of such a child or young person or healthcare professionals delivering clinical research that have worked with children and families when this situation occurred. The study will approach NHS patients within hospital settings. Participants will be interviewed either in person or online. Interviews are expected to last between 30-60 minutes. Participants will be provided with a transcript of their interview for review after the interview. They will be invited to review and feedback on the resources developed at a later stage.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
22/LO/0649
Date of REC Opinion
13 Oct 2022
REC opinion
Favourable Opinion