One of the UK’s first virtual clinical trials, which will recruit patients from the comfort of their own homes as well as hospital settings, is underway in Newcastle.
The move marks a significant step-change in the way patients participate in clinical trials – and how they are run – and has particular relevance during the current COVID-19 pandemic.
Remote access to virtual clinical trials
Virtual trials are remote access trials which use electronic tools to allow recruitment to, and delivery of, clinical trials without the patient needing to visit a recruiting hospital site which could be miles from their homes.
Not only does this reduce the risk in a pandemic environment, but equally importantly it empowers more patients to become involved regardless of their geography. The RELIEVE IBS-D trial, which is testing a new treatment for Irritable Bowel Syndrome with diarrhoea (IBS-D), has already recruited 250 patients at 28 hospital sites across England, but still needs another 180 patients to complete.
By introducing this virtual trial, which will run alongside face-to-face recruitment at the 28 sites, patients from anywhere in the country will be able to take part, with treatment delivered to their own home.
The NIHR Patient Recruitment Centre (NIHR PRC) Newcastle, which is part of Newcastle upon Tyne Hospitals NHS Foundation Trust, has been instrumental in developing the remote access processes for this innovative trial.
This study is certainly the UK's first virtual interventional trial for IBS patients, and one of the UK's first virtual trials of any interventional therapy.Professor Yan Yiannakou, Director of the NIHR PRC Newcastle
Lead investigator Professor Yan Yiannakou, Director of the NIHR PRC Newcastle, said: “This study is certainly the UK’s first virtual interventional trial for IBS patients, and one of the UK’s first virtual trials of any interventional therapy. It is a pathfinder for delivery of clinical trials and may help start a revolution in the way we run clinical trials post COVID-19.”
“Even before the pandemic there was a real desire to develop virtual trials as the current site-dependent nature of trial recruitment can lead to geographical exclusion. Virtual trial capability really empowers patients; it allows any patient anywhere in the country to access the trial. It also means zero hospital visits which makes participation safer and easier for all.”
The RELIEVE IBS-D virtual trial is the product of close collaboration between the team at the Newcastle and a commercial company, Enteromed Ltd. The project – together with the recruitment registry ContactME-IBS – is strongly supported by the local Clinical Research Network (North East and North Cumbria).
Research Network Chief Operating Officer, Morag Burton, said: “The team at Newcastle are always at the forefront of research with new and innovative ideas that can support as many patients and members of the public accessing research as possible.
“This is an excellent example of their dedication and hard work coming to fruition and the Clinical Research Network has been really proud to support them on this journey.”
Elena Markaryan, CEO of Enteromed, the life science company conducting the trial, said: “The RELIEVE IBS-D trial team has gone to great efforts to keep IBS research going throughout the pandemic.
“Working with a forward-thinking NHS team like the one at Newcastle has really helped us transition to this new virtual version of our trial. Enrolment, consent, treatment and doctor visits are all being conducted remotely, without the patient needing to leave their home.”
Engaging patients with common chronic conditions
One of the strengths of the NIHR PRCs is their ability to reach out into communities, beyond the hospital specialist clinic, to engage patients with common chronic conditions such as IBS, migraines and asthma which are often treated by GPs.
These patients have less frequent contact with specialist clinics and are therefore less likely to be invited into research trials. Professor Yiannakou added:
“In the UK we have an exceptional record for recruiting patients from specialist clinics, but only a small proportion our population attend these specialist clinics. So we need to develop methods for reaching out to the community, such as the use of social media and registries of patients who are happy to be involved.
“By reaching out to communities we provide equity of access to all patients, irrespective of geography or disease. Putting research within reach of more diverse populations also has the potential to advance medical progress and lead to better outcomes for patients.”
IBS affects approximately 1 in 5 people in the UK
IBS affects approximately 1 in 5 people in the UK, one third of whom experience diarrhoea type IBS (IBS-D) with symptoms having a huge impact on their quality of life. Patients with IBS-D suffer debilitating symptoms of diarrhoea, abdominal pain, and bloating.
Many have to alter daily activities, refuse social occasions and amend their plans to be near public toilets. Studies also show work productivity and intimate relationships are severely affected by IBS symptoms.
The RELIEVE IBS-D trial is testing effectiveness of the intestinal adsorbent Enterosgel in the treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D). Enterosgel is a drug free treatment, in the form of a gel that is taken orally.
As Enterosgel is not adsorbed by the body it is classified as a medical device. It has an excellent safety record over 20 years and is used in 30 countries. In the UK, Enterosgel is used as a treatment for acute and chronic diarrhoea and results from a recent UK study show that it significantly reduces the duration of acute diarrhoea.
Since I started doing the research programme it has changed my life so much. It's made me feel like I could have a normal life again.One of the RELIEVE IBS-D trial participants
One trial participant on the original trial said: “I’ve been suffering with IBS for years. I was constantly having accidents, sometimes going up to 7-8 times a day. It was affecting my work and personal life. Since I started doing the research programme it has changed my life so much. I haven’t had an accident in two months, feeling so much better in myself I haven’t felt like this for a long time. It’s made me feel like I could have a normal life again.”
Suitable potential participants are aged 16-75 years with IBS-D symptoms. The virtual version of the trial involves four consultations by video or phone over 18 weeks. Participants are required to fill out a two minute daily symptom diary and weekly questionnaires online.