Case study: Patient Recruitment Centre: Newcastle paving the way for UK virtual trial capability

Research staff at the Patient Recruitment Centre: Newcastle have been overwhelmed by the response from patients suffering with Irritable Bowel Syndrome (IBS), who have come forward in droves to participate in one of the UK's first virtual interventional commercial clinical trials.

The RELIEVE IBS-D trial, which is testing a new treatment for Irritable Bowel Syndrome with diarrhoea (IBS-D), is being run at the PRC: Newcastle and members of the public have been invited to take part in the study via a consent for contact registry and digital media campaign.

The ContactME-IBS patient registry has been used to recruit participants, before a two week screening process is used to confirm eligibility and randomise patients to different arms of the study.

It took the PRC: Newcastle team just three days after launching the virtual study to register their first patient, with 85 participants consented from the site after only seven weeks; roughly twice the rate achieved by 28 UK sites using traditional face-to-face processes. This shows the effectiveness of virtual trials, which allow recruitment without geographical exclusion.

The study is the UK’s first virtual clinical trial into IBS and consists of four video call appointments and a two minute daily diary, with participants receiving free Enterosgel drug-free treatment in the post.

Professor Yan Yiannakou, PRC: Newcastle Clinical Director, said:
“We’re very pleased with the progress of the RELIEVE IBS-D study. It has demonstrated that there is a real demand to deliver studies virtually and to allow people to take part from the comfort of their own home.

“As we recruit more participants to the study, we can learn from the systems we have in place for future virtual studies at the PRC, which can help us to reach a wider community more effectively.”

Hazel Forsyth, Senior Research Nurse at the PRC: Newcastle, said: “It’s just the start of the virtual trial journey and it has been great to have been involved from its inception.”

The study offers participants a safe, easy and professional way to get involved in ground-breaking research, without having to travel to hospital sites during the COVID-19 pandemic.

One participant recruited through PRC: Newcastle, explained:

“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.

“The fact that it’s virtual means there is no need to travel far in order to speak with the staff, which is useful as a student. The delivery of the product was very quick and efficient.”

“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,” added another participant.

To find out more about the study, visit the RELIEVE IBS-D study site and the ContactME-IBS registry.