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Accessible transcript: Company perspective: Delivering RELIEVE IBS-D - a fully virtual, commercial trial


Published: 25 October 2021

Version: 1.0

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This document provides a fully accessible transcript for the video 'Company perspective: Delivering RELIEVE IBS-D - a fully virtual, commercial trial'.

Text on screen: Pushing virtual boundaries to improve patient engagement and accessibility

Text on screen: PRC: Newcastle supported Entromed to deliver RELIEVE IBS_D, the largest IBS trial in England

Carol Howell:

The pandemic came on board and really threw a spanner in the works because we had to stop recruiting at the majority of our sites, and so we suspended the trial for some time. And back in March, we were having serious discussions about whether we could potentially carry on with the trial, and how we could go about making sure that we could carry on. To be honest, without the NIHR involvement and without our chief investigator, Professor Yiannakou's input, the trial would've stopped at that point.


Text on screen: The NIHR supported Entromed to transition to a virtual delivery model

Carol Howell:

Working closely with Yan and the PRC team at Newcastle meant that we had the expertise in the staff to help in the design and the development and the testing, and the various logistics that go on behind the scenes for supporting a virtual trial. Otherwise it wouldn't have been possible, especially in COVID times when many of our non-virtual sites had actually closed or were redeploying staff to other duties and had suspended all face-to-face visits. It was an amazing achievement in such a space of time. And it was because of the dedication and the whole work of the team at the PRC. There were other things as well that helped support the fact that we could actually change to a virtual trial.


Text on screen: Utilising innovative digital solutions to support the remote trial delivery

Carol Howell:

So we had the Newcastle Research Informatics team came on board, and they were a valuable part of the swap to a virtual trial, because they had access to the cloud-based application, red cap. And this meant that we could generate an electronic informed consent form, which was vital to be able to consent our patients safely and remotely. They also enabled us to manage pregnancy test forms, and overall gave us both the capacity and also the capability to develop a pre-screening questionnaire for all the patients. And this was really important because it not only helped guide and select the patients, taking them through the screening process, but it also meant that we could keep our screening failure rates to a minimum because we were obviously going to have a large number of patients coming into the trial from all the advertising that we were doing.


Text on screen: The trial adopted innovative and proactive recruitment strategies to engage participants

Carol Howell:

We have been able to promote the trial really well through NIHR resources. So a number of resources have been used. There's a contact me, IBS registry that's been used. There's the research plus me registry. And also the trust themselves have been doing a lot of active advertising for the trial, as have Enteromed as well. I mean, it's been amazing how many patients have actually responded. Since we began the promotion in September last year, we've had a thousand patients that have actually accessed and used the pre-screening online questionnaire, which has been a great source to be able to sort out the eligible patients.


Text on screen: The trial has showcased the role of virtual trials in the future

Carol Howell:

I really believe that the virtual trials have a really important part to play in the future. We are really proud of being part of the first interventional UK virtual trial. And we hope that the study that we have been running will provide some interesting data, some unique data on virtual trial because we are in a unique position that we will be able to look at our study which initially ran as an onsite trial and swapped to being able to run as a virtual trial. So I think it's going to provide some really interesting information and hopefully some encouragement to other clinical research organisations and commercial companies to consider swapping to a virtual trial in the future. And going forward, we certainly hope that all sponsors and funders consider using virtual trials.


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