In this exclusive interview for PCT TV, Kate O'Brien, a Senior Research Nurse at Albany House Medical Centre, explains what primary care research sites in the UK can offer clinical trials. She explores which trials can be placed in primary care, what Sponsors should look for when assessing sites and what benefits they can offer. Read the key highlights or watch the full interview below.
What advantages are there for placing trials in primary care?
‘First and foremost it’s patient safety. Because we are the patients’ doctors we know their full medical history and have complete access to medical records, so for source data verification for patient safety we’ve got everything available to us. Our years of caring for them and for their families mean we’ve got a very good relationship with patients and they feel confident talking to us.
We are in a position to give a completely unbiased view, as ultimately when the study finishes they are still our patients. We can therefore make sure patients are fully informed and ensure they make a decision that is right for them. Given our access to information, we can accurately assess whether patients have the correct support system around them and would be able to cope with the trial protocol.’
What trials can be placed in primary care?
‘Virtually anything, anything you go to see your doctor about, we can run a study into. From chronic diseases such as diabetes, and hypertension, but also more acute conditions like migraines and bladder urgency, then there's vaccine studies, health promotion and even quality of life studies. Any Phase II to Phase IV studies can be delivered in primary care.’
What do you think a Sponsor should look for when assessing a site for trails?
‘They first need to look at the infrastructure; what support has the PI got? Is he a one-man band or has he got a team behind him? Using Albany House as an example we have four investigators, two research nurses, a research practitioner and two research admin assistants, so there is a full complement of staff. If people ring up there is always someone to answer the phone and provide support.
Look at the facility itself as well. Have they dedicated a space to do the research or is it a bit of a side line? Again, with Albany House, we have got a couple of consulting rooms, a lab, IMP store, research office, record storage rooms, we have a dedicated monitoring room so that the monitors do have their own room when they are there and they are not interrupted. We have got a quiet area where patients can complete their questionnaires.
Lastly, look at the experience a site has got. What studies have they done in the past? Have they recruited to these…and have they got the data to support this? We keep statistics on our recruitment rates and our targets met. We did have a first global randomized controlled trial earlier this year and we are currently collecting data on' first patient, first visit' dates met, so we can show that as soon as we are given the green light we act fast.’
How can the trials be made more patient-centric?
‘Our position enables us to make our site as patient-centric as possible, as well as providing trials with the best patients. Earlier this year we started a patient interest group, using some of our patients who have done studies in the past to help us improve the experience. Elements such as improving our website, the patient information leaflets and how practical a study schedule is for patients, we can feedback to the Sponsor. This is a very important element as it allows us to see things from the patient’s perspective.’
This interview was filmed at Partnerships in Clinical Trials Europe (Nov 2017).