Trials in vascular access: a conversation with the clinical research project manager
When we think about a new clinical trial or research project, we might imagine people in lab coats working over test tubes and beakers searching for the next breakthrough. But behind every study is a very important person responsible for keeping the trial running smoothly. We sat down with Clare Dolan, clinical research project manager (Glasgow Clinical Research Facility), to talk about her role in keeping trials running.
Thank you for speaking to us Clare, could you explain your role in research and how it impacts the projects that we fund?
I often describe myself as the glue that holds all the different stakeholders in research projects together, helping to navigate the chief investigator through any issues that arise as the trial gets up and running and after it has concluded. I work with the research teams, the hospitals, sponsors and charitable organisations like Kidney Research UK to bring the project together.
My main responsibility is to support the chief investigator who oversees the design and conduct of the project. I am a step removed from the practical research itself, but like any job you get to know a lot more about the fascinating work that is being undertaken.
Even after the trial has concluded I am still working with the team to make sure the trial closes successfully, so I get to see the project all the way through from start to finish.
Essentially, I have to be a good communicator, a problem solver and an intermediator all in one.
You’re currently working on two studies with Kidney Research UK called StAFF and PAVia, what can you tell us about them?
The StAFF trial is looking at something that dialysis patients will be familiar with – fistulas. Patients are currently given a fistula (a surgical procedure that combines a vein and artery into one vessel that can be used to connect patients to a dialysis machine) about six weeks before they are expected to start dialysis. Unfortunately, a lot of these fail because of thrombosis or stenosis in one of the vessels.
At this point, patients can be offered a graft which works in a similar way but are offered as a backup when the fistula fails. The StAFF study asks the simple question of which method provides better outcomes when offered first to patients who are likely to have a fistula failure.
The PAVia study is for patients who have received a graft and looks at the best way to treat the first occurrence of venous stenosis (when a vein narrows, slowing down blood flow).
Were you aware of the burden of life with kidney disease before you started the project or were you surprised by the condition?
I had a rudimentary knowledge of the condition through my previous work, but I was definitely naïve to the realities that patients face while on dialysis. It really is like having a full-time job and the logistics are something I had not really considered previously. Patients plan their whole lives around their treatment and things like holidays can be very difficult to plan.
In my work, I am involved in different projects and disease areas. Learning about all of them is essential to ensuring I can keep everything running smoothly and helps to put into perspective how important these projects are to patients.
How did you get into your current role, did you always have an interest in research?
I studied psychology at university, with my master’s dissertation focusing on brain training in elderly adults to build up cognitive reserve; that’s where I got my passion for research from. Most people who completed my course went into clinical psychology, but I moved to Edinburgh as a research assistant specialising in dementia trials.
During my time there, I started to get interested in research ethics and the details of how projects really run. It was there that I looked for a job as a project manager which led me to my current position.
We know that the StAFF & PAVia trials are many years away from completion, why is it that research projects take so long to publish results?
Research cannot be rushed, and we ultimately want to get it right so that we can deliver results and innovations for patients. A lot of time is spent setting up these projects, writing the protocol, submitting to the ethics committee and recruiting patients. There are multiple stakeholders involved at every step of a research study to make sure that the trial is safe for all the patients involved. We are rigorous in making sure we have everything in place that we need to keep the trial going without a hitch.
For StAFF & PAVia, we need to recruit around 360 and 240 patients respectively, not just in the UK but across Europe, adding an additional layer of complexity to the logistical side of the trial.
We reported back in June 2023 that the first patient had been recruited to the StAFF study, what would you like to say to anyone who is interested in signing up?
I want to say that patients should not feel nervous about taking part in these projects. Both fistulas and grafts are widely used in the NHS so there is not anything experimental about the procedures. With the help of patients, we can help to improve quality of life for patients by potentially reducing the number of procedures they have.
In the UK StAFF and PAVia are opening in:
Queen Elizabeth University Hospital Glasgow, Guy’s and St Thomas Hospital, London,The Royal London Hospital, London and Cardiff and Vale Hospital.
If you are interested in hearing more about these trials please contact your renal team at your hospital.