RELIEVE IBS-D reports research findings to participants within 12 months of the trial closing
The RELIEVE IBS-D trial continues to revolutionise research delivery by sharing the study provisional findings directly with participants, within 12 months of the study closing.
On 13 April commercial trial sponsor, EnteroMed Ltd, in partnership with NIHR Patient Recruitment Centre: Newcastle, will host a live webinar to share the initial findings of the RELIEVE IBS-D trial with all its participants and research delivery staff. The trial, which closed on 28th October 2021 investigated the efficacy and safety of a treatment for Irritable Bowel Syndrome with Diarrhoea. The rapid dissemination of the research results, direct to patients, demonstrates the ongoing dedication to the design and delivery of patient-focussed clinical research, which has been a priority for the team behind RELIEVE IBS-D.
The team’s commitment to improving participant experience in research influenced all aspects of the RELIEVE IBS-D trial, and was a key driver when it transitioned from a site-based trial to a virtual trial during the pandemic. Patient and public advisory groups were involved throughout the trial design and delivery process make sure the trial was patient-friendly and easy to take part in.
The commercial sponsor, EnteroMed, and Chief Investigator, Professor Yan Yiannakou, Clinical Director at Patient Recruitment Centre: Newcastle, had also pledged to provide the results of the research to patients as early as possible. Professor Yan Yiannakou, said:
“One of the biggest concerns from patients about participation in clinical trials has been the lack of feedback about the outcome of those trials, so we are making sure to prioritise this by providing feedback less than a year after the study closed. This is exceptional for a commercial clinical trial”.
Carol Howell, Research Director at Enteromed, added:
“As a sponsor we have been committed from the very beginning in taking a patient-centred approach to this trial, from design through to implementation. We have seen how successful this approach has been in reaching our recruitment target and retaining participants during the trial. During the pandemic, we all came to recognise the importance of video calls in keeping us in touch with our loved ones but also in our work life. We decided that hosting a participant webinar would be a great way to not only disseminate the results to as many participants as possible, but also our opportunity to thank all our participants for taking part and making the trial such a success.”
The provisional results of the RELIEVE IBS-D trial will be shared with participants within 12 months of the study closing, demonstrating that the team in Newcastle are responding to national patient feedback about their experiences of taking part in clinical trials.
The Participant in Research Experience Survey (PRES) conducted in 2020/21, by the NIHR, reported that only two-thirds of respondents (59%) said they ‘Strongly agreed’ that they had been kept updated during the study, which indicates that the frequency and quality of information provided to many participants in clinical trials is inadequate. It is also concerning that almost a fifth of respondents said they did not know how they would receive the findings of the study they had participated in (19%, Q3).
The research team at PRC: Newcastle, together with the sponsor (Enteromed Ltd) remains dedicated to prioritising patients by not only providing the results in a timely manner, but by doing so in an easily accessible webinar. The patient-friendly webinar will take place on the 13th April at 19:00, to maximise access for working participants. The Chief Investigator and the sponsor, EnteroMed will present the provisional results to participants followed by an interactive question and answer session. This approach again raises the bar in patient-centric research delivery by enabling direct dialogue and bucks the usual trend of post-trial communicating being given via a letter.
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, and as it 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.
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