In this article, Professor Yan Yiannakou talks about how decentralised trials can change how we do clinical research in the future.
I am a gastroenterologist working in the north of England, specialising in irritable bowel syndrome. I have also been Director of Research & Innovation for a large NHS trust and had roles in the Local Clinical Research Network.
My research interests include how we can improve recruitment to clinical trials of common chronic conditions. In some ways, having such a good health service in the UK makes it harder to find people to take part in research. Primary care services, such as GP practices and pharmacies, are highly effective. This means people with common chronic diseases are looked after by their GP rather than hospital clinics.
On the other hand, most research takes place in major hospitals, so there is a disconnect between where the patients are and where research is done. To overcome this disconnect, we need to reach out to the community. One effective way of achieving this is by promoting ‘consent for contact’ registries, where the public are encouraged to highlight their willingness to be approached. Examples include the NIHR Be Part of Research registry and the Research+Me registry.
What are decentralised trials?
Another way of making it easier for people to take part in research is by breaking down geographical barriers. We do this by running ‘decentralised trials’, where research participants can take part remotely without visiting a clinic in person. My interest in decentralised trials goes back five or six years, but it wasn’t until the pandemic in 2020 that we had a chance to run a fully decentralised trial.
The RELIEVE IBS-D trial ran in a traditional manner (with in-person study visits) for the first 210 people who took part, but the second half of the trial was completely decentralised. This meant that we could very quickly find participants from all parts of the country. We were pleased to hear so many positive comments from people that lived far away from hospitals who were now able to participate in research.
Although the RELIEVE IBS-D trial was a huge success, there are still many questions to be answered about decentralised trials. Are participants are more likely to stay in the study because it’s easier to attend appointments? Is the patient’s experience better or worse? Can we use decentralised trials for more complex treatments? Are decentralised trials more or less expensive? Can we reduce the carbon footprint using decentralisation?
It’s important to learn more decentralised trials to see how they can positively change the way we currently do research for the benefit of people around the world. I look forward to being part of further discoveries in the future.