I think we have very good relationships with like the CNS’s [Clinical Nurse Specialists] and the ward staff, I put that down to the, you know, the, the lovely working relationships that my team have because we are always going in, you know, can sometimes be at an inconvenient time. We had a situation a little while ago where some of the CNS’s, there was a few CNS’s and one CNS or a couple of CNS’s would be absolutely fine about us going in to see patients just on the day they’d had, in clinic at the point they’d had their diagnosis and you’d find a little bit of, you know, cherry-picking or gatekeeping and I did a little bit of work around speaking to that, the resisters, I call them resisters, you know, it’s not, it’s not us wanting to put a patient into a study it’s the consultant feels the patient may benefit from going onto that study, may benefit, but also we, we’re experienced nurses and we are experienced and we do know how to approach patients. You know, most of my team have got a lot of experience in the area in which they’re doing the research so yeah, we know that patients might be upset, we know our patients are vulnerable but we know how to handle that. And what we don’t want happening is, you know, three or four years down the line, patients talking and one patient had access to a study, the other patient didn’t have access to the study and that patient, you know, patient perhaps has relapsed so, Why didn’t I get access to that study? and, you know, Because we were told that we couldn’t come and see you because you’d be too upset, and we can’t be paternalistic, you know, patients have to make those decisions themselves.

None of us are funded by the Trust at all and we get what’s called Activity Based Funding Units so we have a target that we set ourselves in many ways but it is also given to us by the Network, Clinical Research Network that we’re affiliated to in this area. And then we have to recruit really a number of, a certain number of patients so if it’s an interventional study then you get 11 ABFU [Activity Based Funding Unit] points, if it’s a non-interventional study with less than 10,000 patients you get 3.5 and if there’s more than 10,000 patients you get one ABFU, so that equates to anywhere between £65 and £85. So half of our funding in my department comes from ABFU funding but that doesn’t really cover the costs of the staff, all of the staff. We get some funding then from supporting and facilitating commercial studies so and one of the high level objectives in the Department of Health is to recruit and open more commercial studies.

Shift patterns, I have core hours so I, for my team so anywhere between 8 in the morning and 6 o’clock in the evening and I think we’re very, very fortunate in the fact that our hours are quite flexible. And I think it’s quite a tough world out there on the wards and in other departments and we are, we are quite fortunate with regards to hours and the level of flexibility but on the back of that then if staff need to stay late there is an expectation that they would, you know, if they can they will stay late because, you know, what we’re finding because clinics are so busy at the moment you’ve got lots of waiting list initiative clinics so some of the clinics start at 8 in the morning so we’ve gotta cover those clinics, some clinics go on until 7, 8 at night, we have weekend clinics so where possible if we’re available, we’ll-, none of us are, our contracts are all Monday to Friday but if we have to come in at weekends and people can cover it then they will and then they just, we don’t have the money to pay for them but what we do is give them time and half back. So yeah, it and I’ve sort of started to warn the staff that things will change, that we will, that, you know, when we develop as a team further and have more funding then because in many ways a lot of patients are missing out, you know, if they’re coming in after 6 o’clock they’re not, might not be offered those emergency studies that may benefit them.

Which is a shame.

Okay, so I guess the research role, research nurse role is very different across the board so, you know, you could go to a clinic-, phase 1 clinical trials unit where you’ll have the nurses actually giving the drugs and things. So we, we’ve, our roles evolved here, so when I first started here back in 2000 I was one of those nurses up giving the chemotherapy but then I realised that actually that wasn’t, that wasn’t my area of expertise, my area of expertise was the research, was understanding about randomisation, reading protocols and understanding about novel therapies and things. So what I try to impress on my team, and it’s particularly difficult for generic research nurses who are perhaps involved in 15, 16 different specialties perhaps none of which are their-, might have been their speciality that, you know, your skills are research that, that’s your, you’re a research specialist so and we try and, we’ve done a bit of work on that at our sort of away-day and things like that.

Just another little thing that we do as well is we don’t just sort of come in and, you know, see patients and say, you know, I’m, I’m part of the research team, what we always say is I work with your consultant and he or she has asked me to come and see you today. And that’s made quite a big difference because we had a study several years ago now where we just went up and saw patients and we were getting quite a, quite a high, patients were declining and then we changed our tack a little bit and then we started saying oh, you know, Your consultant, Dr A, has asked us to come and see you today, and straight away you’ve got that, Oh, okay, is that, alright, okay, and then, you know, and it was an observational study but recruitment increased [laugh] significantly just because, because of that.

Yeah, yeah well I think many, many years ago, your Site Initiation Visits, the sponsor would come up to the hospital but I think with cutbacks and you know, perhaps reduced funding and things like that quite a lot of them are done over the telephone now. So we’ve got a telephone Site Initiation Visit tomorrow and we’ll gather together all the research staff who will be involved in the study. Myself I’ll be there, it’ll be the Principal Investigator and the co-investigators and we’re also getting some of the CNS’s [Clinical Nurse Specialists], because they’re actually gonna be delivering the CTIMP [Clinical Trials of an Investigational Medicinal Product]. So it will be a dial-in with the slides and it’s just a great opportunity to go through the protocol and ask all those questions that you’re just not quite sure about and how you’re going to do the training and, you know, who’s gonna be trained, you know, are they gonna need GCP [Good Clinical Practice] training, how are you gonna run the study, where are you gonna store the drug. Pharmacy aren’t attending tomorrow but they’re attending a separate Site Initiation Visit.

So an ideal Site Initiation Visit would be that I would invite as many people as possible because I think if you get engagement at the very start with the CNS’s as well and support services if they’re ever able to come, then that would be great because they understand about the study form the very beginning. But in reality that doesn’t always happen, that everyone gets involved, but I do, I would invite everybody who I thought might want to be there. And then the ideal would be that they would go through the protocol at the very beginning and everybody was there and ask any questions and that might take about an hour and then at that point all the clinical team, the non-research staff can all go because they don’t wanna go through the Case Report Forms and the electronic CRF and, you know, all the sample handling and things, so that would be-, you know, we’d probably carry for about another hour and then yeah that would be, but that’s a great opp-, I take loads and loads of notes and then from that I start working out the work instructions for the study and how we’re gonna run the study.

In practice.

Yeah, it’s something I feel so strongly about, really strongly about. So the, the sort of things to raise the profile, I mean we do do quite a lot in the Trust. I mean obviously we’re limited with time and we have been subject to funding cuts so we are, you know, quite thin on the ground but we, well we do celebrate International Clinical Trials Day so we go round the hospital. We, the last time we did that, last May we actually took a cake trolley round, that was much better than actually having displays in certain areas in the hospital but I think the patients and public don’t always wanna come up to a display particularly if there is a few people standing by it so the, the coffee and the cakes, that went down really, really well and I think we did raise the profile. We’ve done a few interviews on our local radio station, we go out to-, myself and my colleague go out to schools to talk when we can. We present at charity events, Rotary, things like that where we can. And for about the past four years, I pushed but I managed to get myself onto the student nurse the undergraduate training course so and I’m trying to get more student nurses to come and spend some time with us as part of one of their placements. And that wasn’t easy because even getting the clinical placement facilitators, I don’t know what their job title is now, to understand that our role was like a CNS [Clinical Nurse Specialist] and to try and encourage student nurses-, and we did have a student nurse who came in quite recently and really enjoyed it.

I know in some places research staff don’t wear uniforms but I feel quite strongly that we do wear uniforms because I think that I’m a nurse and in fact in the past we had lots of discussions with my manager at the time about perhaps we all just wear the same, the same uniform and it’s a specific research uniform. And I’m a nurse and I’ve trained to be a nurse, I’m a Sister and I don’t want that taken away from me because that’s how I identify myself and that’s what I want to be. So to me, your uniform is very important and also by wearing a uniform I think you are seen as part of the clinical team. When all my Band 6’s wore the CNS [Clinical Nurse Specialist] uniform they suddenly found it a lot better as well because I think what was happening before that was they were going onto wards and they-, obviously the ward staff would all be everywhere and then, you know, the doctor would come on or relatives would come on and start asking questions and we’d always feel we were going, Oh sorry, I don’t know, I don’t kno, and actually now we’ve got the CNS uniforms the doctors know that we’re not part of the ward team because we’re CNS’s so we’re, you know, we’re coming in and doing what we need to do and then we’re going out, so that’s actually helped quite, quite a bit. But I do feel quite strongly about, about uniforms because I think it identifies us.