We speak to Dr Vanessa Raymont, Associate Director for DPUK and Senior Clinical Researcher in Psychiatry at Oxford University, about the Trials Delivery Framework. DPUK's Trials Delivery Framework aims to match public volunteers with the most appropriate new dementia research studies.
What is the Trials Delivery Framework?
The Trials Delivery Framework is about drawing all the things together that are important when researchers are looking for treatments or preventive strategies for dementia. So, the Trials Delivery Framework is that link between researchers, projects and precision-matched volunteers. It combines all those aspects to deliver trials effectively, efficiently and quickly to get new treatments to the public.
How does the Trials Delivery Framework do that?
One branch of the Trials Delivery Framework is the pre-clinical cohorts. These are groups of volunteers who don't currently have dementia but are interested in taking part in dementia research studies. There are two cohorts: Great Minds and the Clinical Studies Register, which together contain about 50,000 people. They collect data over time from the people in the cohorts about their cognition, medical history, and genetics. This information allows us to offer them research studies which they are specifically suited for. This is important because one of the reasons we have struggled to identify new drugs for dementia is due to too much variability between participants in studies. So, these cohorts have allowed us to do what we call stratification, where we look at people's particular risk factors or medical history, and pair them with studies focusing on those aspects. We are now also developing a clinical cohort of people who already have memory problems, recruited from existing memory clinic services, possibly combining existing local registers. Then we can suggest specific studies to people in the cohort that they are best suited to – as with the pre-clinical group.
Who conducts these research studies?
The Trials Delivery Framework is creating a network of sites that already do dementia research and can deliver those studies. So, when a new drug needs testing, and there is a research study to test it, the group of sites in the network will work really effectively to deliver it.
Does anything like this exist already?
There are other existing initiatives that already do this – like Join Dementia Research (JDR), which is a big national initiative. JDR recruits members of the public as well as people coming through memory clinics, and people who sign up to hear about research. So we're not trying to reinvent the wheel; we're working with JDR so that they are the front end – what people see when they are given a name or a leaflet or a form to sign up to. Then JDR pass their details to DPUK. We can work together to link the people that sign up for these registers to the best study for them.
How will the Trials Delivery Framework help people with dementia?
I think it will help treatment become very personal. One of the big concerns with dementia research is that we are not precise enough when selecting participants. There are too many differences between participants and until we address this variability, we won’t get the best treatment possible for dementia because it won't work for everybody. So, in the future – like with heart disease or high blood pressure – there could be a range of drugs available to treat dementia dependent on people's individual medical history, genetics and lifestyle factors. By selecting people around these factors, we are helping to develop a range of treatments for these very individuals.
How is the Trials Delivery Framework useful to researchers?
It helps make the whole process smoother for researchers. Currently, when a researcher wants to set up a study, they need to write contracts and consent forms, and decide what assessments to do and how to recruit people. That’s all quite labour intensive – especially because sites have slightly different rules about contracts. But if we can develop a network of sites that are all happy to operate in a standardised way, the whole system will be much more efficient for researchers. Instead, they could come to DPUK and access the network, streamlining the whole process.
Are there any examples of Trials Delivery Framework projects that are taking place?
People on the Great Minds register were recently sent kits to do some genetic testing, and look at things like movement. We also have two studies that are developing novel ways of assessing cognition remotely using smartphones, which can be used to monitor really early memory problems. These tests could be done fairly regularly to hopefully detect subtle differences. There are a range of reasons people can't come to clinics, and COVID-19 has reinforced that. However, we must ensure we're not excluding people who can't access that technology. A lot of this research is also looking at how to make it accessible for people who don't have the technology. Ultimately, as well as being useful for monitoring symptom progression, they can also be helpful to assess whether new drugs are working.
How do you match the volunteers with research projects?
When people sign up for Great Minds or the Clinical Studies Register, they consent to be contacted to do regular tests on things like memory. They also agree to be contacted about dementia research studies that they would be suitable for. So, when a new study needs, for example, people with a particular genetic marker and mild memory problems, we can look at the data we've already collected from the cohorts and contact people who meet those criteria. But this is all completely voluntary – as with all research registers and cohorts – so if people don't want to be part of the group anymore, they can withdraw from the cohort.
If somebody has never been involved in dementia research before and isn't part of a cohort and perhaps doesn't have any symptoms of dementia, how can they sign up for the Trials Delivery Framework?
They can go on to the DPUK website and find out details about the pre-clinical registers and sign up through there. These registers have also recruited people from other existing cohorts, not necessarily for dementia.
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