One of the first fully virtual interventional clinical trials to be conducted in England showed a major increase in the speed of recruitment for participants, suggesting a potential new avenue for clinical research moving forward.
Carried out in part by one of the NIHR’s new National Patient Recruitment Centres, the RELIEVE IBD-D trial – which is testing a new treatment for Irritable Bowel Syndrome with Diarrhoea (IBS-D) – was able to recruit 67% faster through a single site using a virtual approach, compared to 28 sites using a traditional approach.
While the results of the clinical trial are yet to be tested more widely, the initial rapid recruitment 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 facilitate recruitment to, and delivery of, clinical trials – without needing the patient to visit a recruiting site, which could be miles from their home.
In the current pandemic environment, this significantly reduces risk for patients and, equally importantly, empowers more patients to become involved regardless of their geography.
Over a period of 70 weeks, prior to the pandemic, the RELIEVE IBS-D trial research time 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. Now though, thanks to the new virtual approach being pioneered by the team at the NIHR Patient Recruitment Centre in Newcastle, trial participation has been extended to patients across the UK – with people now participating in England, Wales, Scotland and Northern Ireland from their own homes.
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.”
Lead investigator Professor Yan Yiannakou, Director of the NIHR PRC Newcastle, added: “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.”