‘Pushing the boundaries’ to deliver early phase research in Wales
Imagine being the first person in the world to be given the opportunity to test a new drug; it’s a drug that might not help you now but it could give hope to thousands of people in the future, living with the same chronic condition as you.
This type of ground-breaking early phase research – when new treatments are tried for the first time in patients – is now routinely available here in Wales.
We’ve been behind the scenes at the Clinical Research Facility (CRF) in Cardiff, and the new All Wales Early Phase Research Partnership (AWaRe), to find out more.
Great for patients
The CRF is based within the University Hospital of Wales on the upper ground floor. Jessie Powell, senior nurse manager, is there to greet us when we arrive and she’s eager to show us around.
“We’re very lucky to have a facility like this because we’re able to offer new treatment options in Wales,” said Jessie. “There are numerous facilities like this in England and if patients in Wales wanted to access phase 1 trials previously they would have to go across the border to get the treatment. So I think it’s great for patients.”
There are many doors along the corridor; behind them are offices for the dedicated research nurses as well as consulting rooms where patients can be taken through the consent process.
Towards the end of the corridor is a door to the left that opens on to a ward with space for eight beds and off to the right is a laboratory, packed with freezers, fridges, incubators and centrifuges (blood spinning machines).
“We wouldn’t be able to conduct the number of early phase trials that we have, or to the complexity, if we didn’t have a laboratory,” explained Jessie. “A lot of the phase 1 studies have numerous blood testing. For example, a patient might need to have a blood sample taken pre-dose, they would then be dosed with the new drug, and might then need to have further samples taken every 15 minutes.
“If you’ve just got one nurse looking after a patient, taking the bloods and also processing them, if they had to go off the unit to do that, we wouldn’t be able to observe the patient to make sure they were safe and happy as well as processing the blood.”
World-first research
Early phase research activity at the CRF has increased in the last year and it’s hoped this trend will continue. The CRF now houses both early phase and late phase study teams, with Health and Care Research Wales funding nurses in both areas to deliver clinical trials.
“We’ve been able to concentrate on the early phase studies because we now have a larger workforce that can go out and do the later phase studies,” said Jessie. “In the past that would have fallen to the early phase team. So it’s quite nice that within the CRF we have an early phase team and a late phase team.”
In August, the first patient in the world was dosed at the CRF with a new drug that aims to prevent and manage type 1 diabetes.
“I think it’s great for patients that we were first in the world to dose,” said Jessie. “Without a facility like this we wouldn’t be able to offer that to patients.
“We really had to push the boundaries with that trial as we’d never actually managed to staff three overnight stays here before. We did it so we know that we can do that but it’s all about what we do next; it’s about pushing the next boundaries.”
Convenient care
Patients taking part in early phase trials may have tried the standard care, for example chemotherapies or immunotherapies to treat cancer, and that hasn’t worked for them.
It’s at that point that they may be eligible for an early phase research drug. In the case of cancer patients in Wales that can mean travelling.
Currently all early phase cancer trials that open in Wales are managed from Velindre Cancer Centre in Cardiff. When a patient wants to explore an early phase trial as an option, they need to visit that centre.
But all of that is changing.
The Wales Cancer Research Centre, funded by Health and Care Research Wales, has helped to develop a partnership – known as AWaRe – between Velindre Cancer Centre and the South West Wales Cancer Centre.
“Our patients in West Wales can now be seen at an information clinic in Swansea to talk about the possibility of entering an early phase trial without travelling to Cardiff for that initial consultation,” explained Sian Whelan, Cancer Research UK Senior Research Nurse at Singleton Hospital in Swansea.
“Before we set up the clinic some patients would make the trip to Cardiff only to be told that there wasn’t a trial available to them. We are updated by Velindre on a weekly basis so we know if there will be a trial available and we can go through a check list with the patient to look at their trial eligibility here in Swansea.”
Kay Wilson, Early Phase Team Lead at Velindre Cancer Centre, described the collaboration as having “huge benefits” to patients and their families. “This joint working is a fantastic opportunity for Welsh patients and our research community in Wales. Together we can achieve great things to impact patients' experience and outcomes."
24/7 research
Both the CRF in Cardiff and the AWaRe partnership have plans to further improve access to cutting-edge treatments in a way that benefits, and is convenient for, patients.
“This is just the beginning,” said Sian. “We hope the service may be extended in time to provide the treatment locally too."
Jessie believes the success of dosing the first patient in the global diabetes trial will open doors to bring more studies to the CRF and Wales.
“What we would like to see in the future is if we conduct the phase 1 study here in Cardiff, that the study team then comes back to us for phase 2 and phase 3 so we can see the drug from first-in-man right through to licensing really. That would be fantastic.
“I think we become very attractive globally as a facility if we can offer that kind of commitment and that kind of staffing for trials, because I know there are a lot of facilities that wouldn’t be able to do it,” concluded Jessie. “We’re not yet 24/7 but I think in the future that’s where we would like to be.”
First published: @ResearchWales Issue 5, December 2018