The experiences of patients taking part in rheumatology trials
Research type
Research Study
Full title
A study to explore the experiences of patients taking part in rheumatology clinical trials
IRAS ID
195707
Contact name
Anthony Jones
Contact email
Sponsor organisation
Keele University
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 5 months, 7 days
Research summary
The purpose of the study is to understand the experiences of patients participating in rheumatology clinical trials. Increasingly, patients and members of the public are involved in the design and conduct of clinical trials. An editorial within Musculoskeletal Care (Gooberman et al2013) suggested that the rationale for involving patients in study design are multiple, and include moral and ethical arguments about citizens’ rights , increasing relevance of research, and the view of doing so can improve research quality, although this may be hard to define (Gibson et al, 2012). The patient in a clinical trial will have a unique insight into the trial processes of recruitment, consent and participation. Gotay (1991) and Kodish et al (1992) support this by suggesting that additional research should be undertaken to understand this insight. By understanding the participants experiences and the positive and negative aspects of their encounters the research can offer suggestions as to how the patient experience can be enhanced which may help recruit more people to research studies and ensure that more participants complete research projects,which would ultimately improve the quality of the research.
Evidence based medicine (EBM) is an approach to medical practice which improves decision making by the use of evidence from well designed and conducted research (Rosenberg & Donald, 1995). Although medicine is based on some degree of research EBM takes it further by classifying the strength of the research by using the evidence from the strongest sources such as meta- analysis, systematic reviews and randomised controlled trials (RCTs).
The scientific gold standard for clinical research is the RCT, RCT’s involving patients that most closely represent what occurs in clinical practice are crucial to enable trial medications to be tested for efficacy and safety in the population that they are intended to benefit. Adult patients who are or have recently taken part in a rheumatology clinical trial will be interviewed either in a quiet room at the hospital or in their own homes,about their experiences.
The study will last for no more than 12 months.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0302
Date of REC Opinion
25 Oct 2016
REC opinion
Further Information Favourable Opinion