Published: 25 November 2020
A collaboration between one of the NIHR’s new National Patient Recruitment Centres and UK sponsor company Enteromed has led to rapid recruitment to one of the first fully virtual interventional clinical trials conducted in England.
This represents a major step forward in developing the UK’s capacity and capability to conduct virtual clinical research in the current COVID-19 pandemic.
Virtual trials are remote access trials which use digital technology to allow recruitment to, and delivery of, clinical trials - without the patient needing to visit a recruiting site, which could be miles from their home. This reduces risk in a pandemic environment and, equally importantly, empowers more patients to become involved regardless of their geography.
The RELIEVE IBS-D trial is testing a new treatment for Irritable Bowel Syndrome with Diarrhoea (IBS-D). Over a period of 70 weeks, prior to the pandemic, the research team had already randomised 224 patients at 28 sites in England, including GP, hospital and private clinics.
Until September, participation in the study had been limited to the catchment areas of those 28 sites. The new virtual approach, developed by the team at the NIHR Patient Recruitment Centre in Newcastle, extended the reach of this trial to IBS-D patients right across the UK - with people now participating in England, Wales, Scotland and Northern Ireland - from their own homes.
The virtual expansion of the trial has also resulted in rapid recruitment and randomisation of participants, with the 50th participant being randomised on Tuesday 17 November, just two months since the study opened on 16 September 2020. This means that the virtual version of the trial has significantly out-performed the site-based version of the trial: a single site using a virtual approach has recruited 67% faster than 28 sites using a traditional approach.
Minister for Innovation, Lord Bethell, said:
“Technology is increasingly instrumental in improving our health. It is crucial that we now take full advantage of the innovations and technological progress made in our fight against common illnesses.
“It’s clear there’s a real appetite to be involved in this research and making trials more accessible will enable people from all over the country to take part, opening the door for even more opportunities.
“This step forward is vital for the UK and our ability to understand illnesses – it means we can develop better treatments at a faster pace and ultimately improve people’s quality of life.”
Reflecting on this success, Dr William Van’t Hoff, Chief Executive of the NIHR Clinical Research Network said:
“The response to the virtual version of the RELIEVE IBS-D trial demonstrates that there is a strong appetite among patients and the public in the UK to embrace digital technology as a tool to enable participation in research. It also marks a significant step-change in how we do research. Virtual approaches may not be suitable for all trials, but we fully expect to see more hybrid and decentralised trials as the research community adapts to the post-pandemic world. The NIHR's new National Patient Recruitment Centres offer an ideal test bed for these new approaches.”
The NIHR Patient Recruitment Centre (PRC) Newcastle, based at Newcastle upon Tyne Hospitals NHS Foundation Trust, has been instrumental in getting this innovative trial underway. To achieve this, the team leading the study developed capability in electronic consent, electronic data capture, online eligibility screening, and implemented facilities to enable clinical staff to undertake video-consultations with participants. They also have access to the ContactME-IBS consent-for-contact registry, which has over 4000 registered patients.
The researchers were keen to demonstrate how a virtual approach can make clinical research more accessible for patients. This has been evidenced with participants enrolling in the study from as far away as Penzance.
As well as benefiting patients, this new virtual approach could set a precedent for future trials in other medical conditions.
Lead investigator Professor Yan Yiannakou, Director of the NIHR PRC Newcastle, said:
“This study is certainly the UK’s first virtual trial for IBS patients, and one of the UK’s first virtual trials of an 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 leads to geographical exclusion.
“Virtual trial capability 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. For researchers and the life science industry, the virtual approach increases our recruitment reach and power, so we can reliably answer our research questions, and ultimately improve treatments and care.”
A participant from the virtual IBS-D trial said:
"Being able to do this research study virtually meant I was able to participate with ease. I didn't need to travel anywhere and it was able to be done within my own home and time. It means that the research study has been able to reach people nationally and not just in and around Newcastle. The team really put me at ease and have regularly checked up on me either by phone or through a web call. It has made the whole experience so much easier."
NIHR PRC Newcastle is one of five new National Patient Recruitment Centres dedicated to setting up and delivering late-phase commercial clinical trials in the NHS at pace and scale. The centres work collaboratively through an innovative ‘franchise-like’ model and operate in an identical manner to make it easier and quicker to deliver commercial research in the UK.
The new centres are also intended to provide a test bed for new approaches to commercial research delivery, process design and future innovation. This includes virtual, hybrid and decentralised trials, which are becoming increasingly topical in the wake of COVID-19.
Elena Markaryan, CEO of Enteromed Ltd, 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.”
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.
About the RELIEVE IBS-D trial
The RELIEVE IBS-D trial is testing efficacy, tolerability and safety 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.
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. Recruitment to the virtual trial will now take place alongside recruitment which continues at the 28 sites.
A pre-screen questionnaire enables patients to assess their eligibility to participate.