ContactME–IBS
Research type
Research Study
Full title
How effective is Consent for Contact in increasing opportunities to participate, and patient recruitment to IBS clinical trials?
IRAS ID
219937
Contact name
Yan Yiannakou
Contact email
Sponsor organisation
County Durham & Darlington NHS Foundation Trust
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Strategies to improve patient recruitment into clinical research studies have been the focus of interest in the last decade, as increasing opportunities for patients to participate in research that is relevant to their health, remains a priority for the NHS. Clinical gate-keeping, poor information sharing across Primary and Secondary Care, and a lack of widely available information regarding research opportunities adds to the challenges.
Research into Functional Bowel Disorders such as Irritable Bowel Syndrome (IBS) remains underfunded in comparison to other areas of medicine, increasing the challenges further in this patient population. Furthermore, studies tend to be secondary care based, unless there is Participant Identification Centre(PIC) site involvement from Primary Care within the study.
The UK prevalence of IBS is 12%, rates are higher for women than for men, and younger people are more likely to be affected than those older than age 50 years. 4.8% of UK prevalence is formally diagnosed by a doctor. 90% of formally diagnosed sufferers across Europe have seen a General Practitioner (GP), with only 28% reporting seeing a Gastroenterologist. These figures suggest a large proportion of patients with IBS in the community, who may be eligible to participate in clinical trials which are currently only available in Secondary care.
IBS is mainly treated in the community, and patients attending tertiary services are often unsuitable for clinical trials because of their symptoms, or co-morbidities. To maximise opportunities for patients with IBS in the community to access and participate in relevant research, further work is required to investigate the Consent for Contact (C4C) process. Studies to explore C4C have been successful in improving awareness of, and recruitment to, clinical research. ContactME-IBS will investigate the impact of voluntary C4C approaches to clinical research recruitment.
REC name
East of England - Essex Research Ethics Committee
REC reference
17/EE/0250
Date of REC Opinion
14 Jul 2017
REC opinion
Further Information Favourable Opinion