Research on the experience of participating in a clinical trial v1_0
Research type
Research Study
Full title
Development of an end of study questionnaire to evaluate the experience of participating in a clinical trial
IRAS ID
154871
Contact name
Elaine Brohan
Contact email
Research summary
Taking part in a clinical trial is a major decision from a patient’s perspective and participation can have an impact on their life. To gain further understanding of how it is possible to improve patient-centred care and patient engagement in healthcare, this project is to develop a questionnaire which will offer a structured method of ensuring that clinical trial participants have a mechanism to feedback on their trial experiences.
To ensure the post-trial questionnaire assesses all concepts relevant to clinical trial participants, focus groups with people who have previously taken part in clinical trials will be conducted. Specifically two focus groups will be conducted with participants who have taken part in oncology clinical trials and one focus group will be conducted with participants who have taken part in a clinical trial at the GlaxoSmithKline Clinical Unit Cambridge. These populations will be targeted as they are the context in which the post-clinical trial questionnaire will initially be used. The focus groups aim to identify key concepts of importance to clinical trial participants relating to their experience, and information they feel it would be valuable to provide in a post-trial evaluation. These insights will be used to confirm the themes explored in the existing draft post-clinical trial questionnaire and identify any further concepts that may be important to address. The focus groups will be carried out in parallel with a literature review which will also help to inform questionnaire development.
In a second phase of the study the proposed questionnaire will be trialled in one-on-one cognitive interviews. These interviews, with participants who have taken part in a clinical trial, will be used to test the validity, relevance and ease of use of the post-trial questionnaire.REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0767
Date of REC Opinion
23 May 2014
REC opinion
Further Information Favourable Opinion