Lived Experience of Adolescents Participating in Clinical Trials V1.0
Research type
Research Study
Full title
Understanding the Lived Experience of Young People aged 12-17 with Chronic Conditions who Participate in Therapeutic Clinical Trials.
IRAS ID
266577
Contact name
Claire Camara
Contact email
Sponsor organisation
University of Northumbria at Newcastle
Duration of Study in the UK
1 years, 7 months, 29 days
Research summary
The need for paediatric participation in clinical trials is well documented (Cain and McGuiness, 2005) due to development and physiological differences as well as diseases that naturally occur in young people (Joseph, Craig and Caldwell, 2015). Which lead to clinical trials for young people being integral to the development and safety of new treatments (Woolfall et al, 2013). Due to modern medical advances, children who previously would not have survived infancy and childhood are living with chronic conditions into adulthood, however this is often without prospect of curative treatment (Rao et al, 2007; Moreira et al, 2013; Ferro, Gorter and Boyle, 2014). It is estimated that approximately 30% of families in the UK currently include a child or young person with a chronic condition (Thornton, 2016). For some children and young people, living with chronic conditions equates to living with restrictions that affect their quality of life (Eiser, 2004). Nevertheless there is currently a dearth of evidence on the subjective experience of clinical research participation of young people (Barned et al, 2014; Crane et al, 2018).
This research is interested in the experiences of 12- 19 year old young people who have a chronic condition and are choosing to participate in therapeutic clinical trials with a specific interest in their quality of life while taking part. The study asks the young people to make an interview prompt called a Thought Bubble during or soon after a clinical trial visit (the choice being the young persons) photograph, voice, written/ drawn. Then to take part in an interview, online, when it is convenient for them. The process is repeated 10-12 weeks after the initial interview.REC name
London - South East Research Ethics Committee
REC reference
21/PR/1682
Date of REC Opinion
6 Jan 2022
REC opinion
Further Information Favourable Opinion