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.



  • 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


  • Date of REC Opinion

    13 Oct 2022

  • REC opinion

    Favourable Opinion