Case study: RELIEVE IBS-D: The power of collaboration
How trust and close collaboration led to the success of the RELIEVE IBS-D trial
The RELIEVE IBS-D virtual trial is arguably one of the NIHR Patient Recruitment Centre: Newcastle’s biggest successes, having been widely praised for its innovation in adapting to the post-pandemic world.
The aim of the trial was to investigate Enterosgel®, a treatment for Irritable Bowel Syndrome with Diarrhoea (IBS-D). When the COVID-19 pandemic hit in early 2020, the trial was redesigned to become virtual, using digital technology to recruit participants from across the UK. The ability to recruit patients remotely resulted in much faster recruitment to the trial and multiple award nominations and wins for the study team.
In this article, we explore how the trial’s success was built on a relationship of trust and close collaboration between PRC: Newcastle and the sponsor company, EnteroMed.
Professor Yan Yiannakou, Clinical Director at NIHR PRC: Newcastle and Chief Investigator for RELIEVE IBS-D, explained how the relationship originated in the early days of the trial: “From the beginning, the team at EnteroMed put faith in us and gave us the freedom to shape the study the way we thought it would work best. An early example of this was at the design stage of the trial. We were keen for the study to run as smoothly as possible and wanted to seek input from others to help refine the trial design. We contacted Elena Markaryan, the CEO at EnteroMed, who was receptive to my feedback and comfortable with the idea of consulting others.
“Usually, clinical trials are designed in-house and follow a set pattern, but in this case we set up a steering group, a data monitoring committee and patient focus groups to help shape the study. The sponsor was willing to take external advice and it was a great experience working with them.”
Elena Markaryan, CEO of sponsor EnteroMed said: ”We were fortunate to be able to work with Professor Yiannakou and his team on this study. With their clinical expertise and valuable patient input into the study design, I believe we achieved a world-class study. We hope that the excellent study results we obtained will help more people with IBS-D manage their symptoms and improve their quality of life”.
When the pandemic hit in early 2020, PRC: Newcastle was forced to suspend studies for a while and the RELIEVE IBS-D trial was at risk of being closed. However, EnteroMed were eager to continue, and the idea of the virtual trial began to take shape.
The study team and the sponsor began to meet on a weekly basis to shape the virtual study design collaboratively. Patient and public groups were also heavily involved to make sure the trial was patient-friendly and easy to take part in. In September 2020, the team’s hard work paid off when the study reopened in its new, virtual format. The new design meant that participants could be recruited from across the country, regardless of their location.
Carol Howell, Research Director at EnteroMed, expressed her pride in being part of the team that made the virtual trial possible: “When the pandemic happened, we couldn’t see how we were going to carry on recruiting to the trial. If the virtual trial hadn’t been developed, we would have had to close the trial early. I feel privileged to have been part of something so innovative that could change clinical trials for the future and make them more accessible to all”.
“RELIEVE IBS-D was able to go ahead thanks to the close collaboration between us at EnteroMed, and Yan Yiannakou, the Chief Investigator. We also couldn’t have done it without the excellent infrastructure at PRC: Newcastle and the huge support we got from the NIHR Clinical Research Network.”
Anu Kemppinen, Study Manager, agreed: “The whole experience has been simply fantastic. Everybody involved has been so dedicated and I can’t praise them enough. I have worked on a number of studies throughout my career and what stood out about the RELIEVE IBS-D trial was the good collaboration and communication between the Chief Investigator and the sponsor. Often sponsors are in a hurry to press ahead with the research, but we really took our time with this one to get everything right.”
The RELIEVE IBS-D trial closed in October 2021. PRC: Newcastle successfully recruited 267 participants to the study in person, which included 229 participants to the virtual trial. The trial data is currently being analysed and the team is planning a webinar to disseminate the results to study participants in the coming months.