This is our discussion with Steven Edmunds which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the interview below is adapted and not a transcript. This was done to improve readability.
Interviewer: Welcome to today’s episode of the podcast. The topic today is the role of the nurse practitioner in clinical research, but also as a career path for nurses. While this role has existed in the US for relatively few years, it’s quite new in the UK and also not very popular in European Union countries. For those who are not familiar, I hope they’ll become familiar today after our discussion.
My guest today is Stephen Edmunds, who is an advanced nurse practitioner in the sarcoma team at Roma Marsden Hospital in London. Stephen is a very experienced and knowledgeable nurse, having worked for years as a research nurse before moving into the role of nurse practitioner. He’s currently working in clinical research as a sub-investigator. In addition, he has done quite extensive research on the requirements for nurse practitioners, which is part of his thesis.
My first question for him was to ask him to tell us more about that role. How do you become a nurse practitioner? And who would qualify for that role?
Stephen: First, thank you for inviting us today, Olga. The concept of nurse practitioners or advanced practice nurses emerged from a need for greater healthcare professional coverage, possibly due to a shortage of doctors, mainly in the US in the 1960s and in the UK following in the 1970s. Over the decades, we are now seeing allied health professionals, such as pharmacists, physiotherapists, and dieticians taking on more advanced skills that you might typically associate with doctors, such as diagnostics, prescribing medications, and assessing patients through physical examinations.
As this has been an evolution, you’ll find that there’s quite a bit of confusion for people, which is not surprising, because different terms have been used over the decades. You’ve gone from nurse practitioners to advanced nurse practitioners, then to advanced clinical practitioners, allowing other non-medical health professionals to be included under that umbrella. And I think the current trend is moving towards becoming an advanced practitioner, at least in the UK.
It’s quite well established in most areas in the UK health system and the biggest anomaly is clinical trials and research. Traditionally, we’ve always thought that this couldn’t be done because research protocols and guidelines are typically black and white. There are certain roles defined that a doctor would do, and the nurse would do other things. However, things are changing, nurse practitioners in the US have been working in trials for some time.
I think American Society of Clinical Oncology (ASCO) predicted a shortage of oncologists back in 2015, and as a result, they expanded their advanced practitioner workforce from 3,000 to over 10,000 nowadays. There’s a keen interest in trials for some people as investigators or principal investigators in some cases. I believe within the UK, we have a network of senior nurses working as advanced practitioners, some at consultant level, all involved in trials. We keep in touch with our colleagues in Birmingham and the Christie in Manchester, for example.
We introduced this role after a period of development within our hospital Trust in 2022. We had already completed the prescribing course qualification a few years earlier, about 3 or 4 years before that. Therefore, it has been a work in progress and truly a result of ongoing development.
In my role, I am listed on the delegation logs as a sub-investigator. We also have doctors who are sub-investigators and principal investigators. We really adopt a team approach, so none of us works in complete isolation. We operate as a team and attend clinics together. I see patients independently, review and assess them, especially regarding their clinical trial side effects, and offer ideas and interventions to help manage these side effects so they can tolerate and stay on treatment longer. To do this, I needed to complete a master’s in advanced practice.
Who would qualify? Well, based on our experience, there are about five or six of us now, but we all used to be research nurses before, and we’ve been interested in developing ourselves. We’ve pursued the advanced practice route and applied it within clinical trials. I haven’t seen any colleagues who are already advanced practitioners in other areas entering clinical trials specifically. We already have years of experience as research nurses, familiar with protocols and how things need to be documented from clinical trial monitoring perspectives, so we can bring those skills together. Yes, it does open up a potential new pathway for research nurse development.
Interviewer: That’s great. It’s basically like a career progression for nurses.
Stephen: Yes, and I think you know it’s quite limited in the research nurse world. There are few avenues for progression, so this really offers a new way to develop yourself and improve your job satisfaction from being able to complete an episode of care for a patient entirely, which also helps with retention.
I think you’ll appreciate that from monitoring point of view there is a continuity, because our registrars come and go. However, our patients really value continuity and a familiar face. It doesn’t mean you have to see them all the time, but just knowing them since nurses tend to stay while doctors move through their training and on to other areas, unless they become consultants.
Interviewer: That’s true. What you say is very interesting, actually. I recently had a clinical trial. It was with a drug that is already on the market, and one of the principal investigators was a nurse practitioner. In your role, you could also act as a Principal Investigator, particularly when working with drugs that are already approved for market use, allowing you to prescribe them.
It was very interesting because I had questions from colleagues in the European Union countries asking whether that person was actually qualified to do the work. I had to explain to them that, in fact, yes, they are fully qualified, and technically, you can also be a principal investigator, which I think is quite good. Perhaps you’ll have that opportunity in the future too.
Stephen: Yes, that would be a good goal to aim for. I think many of our clinical trials are in the early stage of development, so it might not be suitable right now; however, I believe it highlights the value of doing this podcast, as it hopefully raises our profile. We attend conferences and present our results in our role. When I spoke with some pharmaceutical companies, they showed great interest, but hadn’t heard much about it before. Once we discussed it, they recognised the value in it, which is fantastic from my perspective, because how it is received in industry can vary.
I’ve been quite fortunate, and most people have been quite supportive. I know some colleagues in other parts of the country sometimes face some resistance, but I think that’s partly due to the changes in Good Clinical Practice (GCP), which are helpful because they’ve removed some terminology that was exclusive to doctors. It’s about creating awareness of that role, not just what you might immediately think of as a nurse, but as nursing with additional skills.
Interviewer: That’s brilliant. Can you just tell me a little bit about how you manage your increased workload? I can imagine from a hospital point of view, it’s very tempting. I have that person who can actually prescribe and do everything a doctor can, so it’s probably very tempting for them to push you to do more.
Stephen: I think the role is different from what I was doing before as a research nurse, and now I am more established with three years of experience, with clearer boundaries in place.
Initially, because I was new to being a nurse practitioner, I didn’t feel confident. However, I had to adapt quickly to acute oncology in that role. Afterwards, I returned from maternity cover to clinical trials, which gave me valuable exposure to that area. Then I moved back to my usual speciality. At the start, as I was establishing myself, I thought, ‘ I’m now being paid more, so I need to justify my worth. ‘ It was somewhat quieter initially, so I found myself doing tasks I used to perform with the research nurses and similar responsibilities.
But as you become busier and more established, I am able to step back from that role with the support of the team. I am essentially treated like one of the doctors or fellows. I’m no longer expected to get involved in the research nursing side. And the time I regain from not being around, delivering treatments, or not planning, booking appointments, cancelling appointments, or arranging travel for someone, all of that time that I’ve gained back. It kind of balances out.
I’d say my responsibilities are different. I don’t think I’m necessarily busier, and there’s potential to be busier, but it also gives me a lot of time and scope for creativity when we haven’t got clinics. There are a few days a week when I have no clinics. Once I am up to date with the tasks I need to complete regarding the patients I have seen, their letters, and documentation, they are filling in the clinical trial paperwork for that.
I can get involved in other areas because part of advanced practice is that we help and support the clinical side of things. We also have what they call the four pillars: leadership, management, our own research, and education. Being able to get involved in education and teaching not just within our unit and promoting clinical trials in the hospital Trust, but also in other areas like life support and similar fields, is really quite enjoyable. A bit of variety is the spice of life, right? I feel very fortunate to have the opportunity to do such things.
Interviewer: That’s brilliant, and it’s really good that you have the opportunity to explore different things, so you’re not just stuck doing the same thing.
So, my other question was about physician associates. You probably heard there’s been quite a lot in the news about it. I read on the NHS website, particularly for these roles, what a physician associate is, and it says that people with a nursing background, but also those with a science background, could qualify to become one.
The Physician Associates’ role involves collecting medical history, analysing lab results, performing physical examinations, diagnosing illnesses, and other activities.
What is your view on the role of physician associates, and how does it compare to nurse practitioners? Do you see this as a potential solution to the resource crisis we face in healthcare? What’s your opinion on that?
Stephen
My understanding of the physician associate role is that it typically requires a relevant first degree, followed by a 2-year master’s program, after which you can enter practice.
So, one of the two key differences, I guess, is why someone might choose to be a physician’s associate. If you’re already a nurse, I think it may not make sense to train as a physician’s associate, as you could instead train to be an advanced practitioner nurse. You can do everything a physician’s associate can do, but with many years of nursing and direct patient care experience.
The main difference now, and I am open to correction, is that I believe physician associates currently cannot prescribe medications. It’s not part of their usual training, which I think partly explains some of the media cases you’ve seen in the news, such as misdiagnoses or incorrect treatment.
Well, it’s not just that; they see somebody, then have to go to a doctor for a prescription, but that doctor might not see the patient either, resulting in duplicated work. Because I guess there’s always going to be an area where, even as a doctor, you might make a mistake, and nurses will also make mistakes.
So it’s not suggesting that one is better than the other. It’s simply a different route into it, but that comes with some limitations. And you asked whether it was the solution to the crisis. I’m going to sit on the fence about this.
I don’t think that having advanced nurse practitioners or physician associates is necessarily the solution to training more doctors. I believe that if we, as a nation, want more doctors, then we need to take action. There needs to be funding, and we also need to make medicine appealing so people want to enter and stay in the field, because a lot of debt is incurred during training, which is now longer attractive.
So I see these roles as complementary. We bring in physicians, physician associates, as well as clinical practitioners or nurse practitioners. We bring a unique set of skills and perspective to the role. There is a role for this to exist alongside the traditional medical team, complementing it and enhancing the team’s effectiveness. It serves as a link, truly the glue, connecting patients, their relatives, the nursing staff on the ward, and the medical team.
They will fill gaps in medical rotas, but it’s not the only solution. I think it’s more complicated than that. I had an example here: Part of my role involved seeing patients under supervision when I had prescribing rights before I completed my entire nurse practitioner training. That issue came to the forefront during the start of the pandemic. We were in a situation, as you may remember. It’s all a bit of a blur, isn’t it?
But we had about 100 patients on clinical trials, which might not sound like a lot, but we’re a rare tumour group. So, that’s a significant number for a rare tumour group at a single centre. At the time, we had three fellow doctors in training who were research doctors, and all three of them were off sick with COVID simultaneously, but I was fine. But that meant I could proceed to prescribe and assess their treatment over the phone. There was a big sudden move into doing things remotely, and where possible, we had blood tests done locally and couriered out tablets to people.
So, it means the service can continue the contingency plan, and the same applies in the clinic if someone is off sick, we then have that flexibility. We’re still able to see patients without pulling a consultant away from their other clinics or responsibilities.
Having these roles does free up consultant time, allowing our clinic and NHS consultants to see more new or complex patients. This means nurse practitioners, in general, can see more routine care patients, such as those on long-term therapy or under follow-up surveillance. They no longer need to be doctors for these tasks, which frees up doctors to focus on patients who genuinely need their expertise.
Interviewer: That’s very good. I must admit, I’ve always been somewhat sceptical about involving scientists in healthcare. The reason is that I know quite a few scientists, and they don’t always possess the people skills needed to work effectively with others. That’s always been a challenge.
Stephen: My experience with physician associates is limited. I’ve only encountered them briefly.
I haven’t encountered them personally, but only very briefly in a professional capacity. We don’t have any trials involving them that I’m aware of here, and similarly, you can find doctors who are very much science-based.
I would hope that part of the appeal that encourages someone to move from pure science into a more patient-facing role is, hopefully, some of that desire to be outside a lab but engaging with people. So, hopefully, conversely, maybe you might even attract more people with better interpersonal skills than you would traditionally.
I used to be a biochemist and worked in the lab and similar settings. I remember working in an immunology lab next door to the micro lab, and I thought, oh my gosh, if I get to that stage where I prefer talking to my samples growing in my dish, like some of my colleagues, then I realised this isn’t the right path for me. So I avoided that. I think it’s self-selecting in that sense.
Interviewer: That’s interesting. I think I’m saying this because I used to work for a patient organisation that supported HIV positive gay men, and I’ve seen many people become really frustrated with how they’ve been treated, being sent away and having their problems ignored. From a patient’s perspective, they faced many issues, including problems dealing with the healthcare staff, and if you have people who don’t have the skills, it could actually make it worse.
Stephen: You’re right, and I’m actually going to share the results of one of my recent surveys. Since it’s a new role, I wanted to conduct a survey with patients I have seen, as well as with colleagues, doctors, consultants, research nurses, and pharmacists, about their perceptions and satisfaction with this new role. And, interestingly, they’re all very positive, and we’ll eventually get around to writing it up and publishing it. It’s going to some conferences in Birmingham, in Yukon, later this month or next month.
But there were many tasks I described, such as explaining scan results, providing support outside of the clinic, prescribing medication, and obtaining consent. There are many different things I do, and sometimes a doctor would do them as well. I asked them to rate how it compares, worse, the same, or better and luckily, nobody said worse.
Most respondents said their experience was better or the same, highlighting really positive responses. However, the recurring themes mentioned were those you allude to, like supporting skills, listening skills, and giving time and attention. These were among the most frequently mentioned comments.
They felt as if they were the only person on clinical trial and had all the time in the world to talk about how they felt, not just about the treatments but also about how they were getting on with life, being on a clinical trial with a treatment that probably wouldn’t cure them of an incurable type of cancer. But getting on with the data, I think nurses bring a wealth of clinical experience to the role, along with bedside experience. I would hope that comes through in the patient relationships.
This is what they were saying in the survey, which was really encouraging for me to hear. To hear that feedback was important because sometimes you might think, ‘Oh my gosh, is this really helping?’ or wonder if what the survey showed truly reflected reality. For me, it felt like I needed to see a large number of people just to justify my existence.
And I do see a good number of people, comparable with the fellows. But more importantly, what I got from that was that a lot of the free text feedback shows they value time and continuity that they don’t have to explain everything again. They can just pick up where they left off, and give them that time to be listened to.
Interviewer: That’s definitely something I’ve heard back from patients. They just needed someone. Sometimes they need someone to explain things to them because they’re worried or scared to ask a doctor. They might think they’re bothering the doctor with too many questions, or simply don’t want to ask at all.
Stephen: I think we don’t want to appear as if we don’t know something in front of others, and not everyone explains scans results in detail. It’s just like the scan’s fine, and that could be it.
Whereas I give them the report, then I’d walk them through it word for word and try to translate the radiology talk into meaningful English, and so on. I thought everybody was doing that, but it turns out not everyone is.
They want to know that because patients have a right to their results and to receive them in a way they can understand.
Interviewer: That’s the case, and I think you answered that question very well, but I’ll still ask you anyway. What motivates you to work in clinical research?
Stephen: That’s a good question, and I gave it some thought. I mentioned earlier that I started out as a biochemist, and when I was 16, I was quite a geek. I remember attending an immunology summer school. At the time, I wanted to do medical research because I wanted to find a cure.
You know how enthusiastic and optimistic you are at that age. I was advised by the doctors there to start with biochemistry, and then I could do my master’s in immunology. It would be a good foundation. I thought, ‘OK, yeah, let’s do that’. I wasn’t sure when to start biochemistry, and I remember thinking, Oh my God, all those things I hated at A Level, Krebs cycle and this and that. That’s my entire degree, but luckily, it’s very modular, so I was able to avoid a lot of biochemistry and focus on the things that interested me.
I worked for a while as a monitor and in some labs for industry, but what I missed was having meaningful contact with people and helping them. I was actually quite inspired by one of the research nurses at one of the sites I used to monitor. I was inspired by her compassion for the patients, as we never get to meet them during monitoring. You read all about them, and you feel you get to know them a bit from the notes. But when you take that data out of the hospital back to the office or to the sponsor, it’s all anonymised. So they are literally just a number, and that didn’t sit right with me, and I was inspired by that.
So I looked into nursing, and after about eight years working in various clinical environments, I got back into research nursing. I returned and engaged in research nursing from a different, varied perspective, looking at it from a different side of the fence.
And I think especially for sarcoma, it is fascinating from a disease perspective because there are so many different types of conditions classified under that term, and they can all behave very differently. They are very challenging to treat in the metastatic stage, and currently, there is no cure. Sarcomas can develop anywhere in the body, which makes the disease particularly intriguing, but it also highlights the need for ongoing research to find cures. We can only make progress through research. To me, there is a great need for that because it really helps us understand our patients better.
There’s a lot of laughter in the clinic, and you get to know them well when you’re really close. But beneath the surface, especially at the beginning, when this is the worst time of their lives, they’ve been told about this metastatic disease that hardly anyone has heard of and for which there are no effective treatments. So, it’s not just about starting their treatment but also about supporting them and being there for them, even when we don’t have all the answers – and even the doctors don’t, especially when it comes to treatment. Being a source of support both in clinic and outside really helps people.
You mentioned about helplines and such; we offer the same to our patients on trial, so they know they can contact us from Monday to Friday, and we will respond. We’re available by phone or via email.
Interviewer: That’s great, and I’ve noticed that, although not many people, I see quite a few like you who are really motivated and understand the value of research. However, I also observe some who find it very important from their perspective, such as for personal fulfilment or genuinely wanting to help and do something for patients. We need more people like you.
And my very last question, Steve, I want to ask if you think there is enough awareness about nurse practitioners. Do you think nurses are aware of this as a potential career path? Is there anything we can do to raise more awareness?
Stephen: I think that outside of clinical trials, there is a strong awareness of advanced practice roles for nurses and other allied health professionals. However, research is still in its early stages. Who knows, because there may be only about six of us in this hospital Trust working in that role.
Nationally, I don’t have an exact number, but we do have a national forum that meets twice a year. It provides peer-to-peer support for individuals in training, qualifying, and those who are qualified. Some of them are already nurse consultants and principal investigators. We’re already doing it, but everywhere else still needs to catch up a bit. Of course, safeguards and similar measures are also necessary.
Currently, the nursing regulator is reviewing its standards on advanced practice from a nursing perspective, considering future regulation and the best approach. But there’s no one-size-fits-all solution at the moment. There are now changes; many of the courses are accredited, meaning they meet a certain standard. If you’ve completed the course before it was accredited, you can apply to gain more extra work, reflections, essays, and critiques to earn a voluntary digital badge from the Centre for Advanced Practice, which is one of his NHS options.
It would be interesting to see how a regulator responds. What would I change? In research nursing, as I mentioned earlier, career progression is very limited. When I first started, you’d enter as a band 6, possibly a band 7, depending on the hospital Trust. So, you might be a research nurse, a senior research nurse, or a team leader, and that’s about it.
Now within our trust, the research nurses, all of whom are involved in oncology, take on what is called the key worker role. This is the role that, if they weren’t on trial, patients would be under the care of a clinical nurse specialist. So it’s principally about being the sole and main point of contact if they have any problems during their treatment or from their disease.
So, yes, raising awareness, but that’s also about raising awareness from and for the industry, hopefully too. It’s right to be curious about the role and to ask questions, but if we can ensure the setup within the individual site is good, then we can demonstrate the steps we take to oversee and govern that role.
For example, when I, as someone giving consent, have completed the consent training course, and we as a group decide that we want to have some oversight from our Principal Investigators (PIs) if they delegate us to obtain consent, we create a document that will be filled out. This document will outline what the study is about, including the purpose, risks, benefits, and alternative treatments, presented in patient-friendly language so I can explain it to the patient. Then I get my PI to sign it, and I also need the head of research nursing for all our trials to approve it as well.
When I recall discussing that with a pharmaceutical company, they were very surprised but ultimately reassured by that level of oversight and governance. Regarding my prescribing practice, that’s quite normal.
We must work within the scope of practice for our specialities, which needs to be agreed upon by our Principal Investigator and our head consultant for the unit. Then it goes to a non-medical prescribing committee, and you appear before the committee. They will ask questions if there’s anything relevant, and all the information must be linked to appropriate national and local guidelines. We must do this every year to keep everything up to date, which adds extra oversight. You wouldn’t get that in medicine; once you’ve got your General Medical Council (GMC) number, you’re ready to go.
I’m not suggesting this is better, but I want to highlight that the term ‘advanced practice’ has been historically misused as it has evolved over time. If you look deeper, hopefully in a clinical trial setting, people are aware that we need to demonstrate that we are qualified and that we are safe, both for our colleagues in industry and for the public. I believe that, in time, some form of regulation or protection for that role will likely come from the nursing regulator, but we will have to wait and see.
So watch this space. We’re doing it, and it works. It’s been impressively received from both patient and clinician perspectives. In fact, nearly two-thirds of the clinicians said they wanted more in clinic, and that really surprised me.
Interviewer: Thank you so much. I think that we’ve learned a lot from you.
I think the main key message from our discussion today is that research nurses have the opportunity to become nurse practitioners if they’re interested; there is a pathway for them to do that. It’s important for those who are highly experienced and seeking to take on more responsibility to give them that opportunity.
And the other, I think very important thing, is for the industry to understand that nurse practitioners are fully qualified. They can operate as Sub-Investigators and, in some cases, they could even be a Principal Investigator, depending on the type of study. So, I think these are the key points I want to emphasise to people, and thank you for coming to speak in person.
