This is our discussion with Dr Daphne Hazell 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. Our topic today is the role of general practitioners (GPs) in clinical research. For those of you who don’t know, a general practitioner is equivalent to the family doctors that some countries have. We tend to focus on secondary care and clinical research conducted in hospitals, while primary care settings are often overlooked. This is why I have invited my guest to speak today about primary care clinical trials.
My special guest is Daphne Hazell, a physician and GP by profession. She has many years of experience working in the healthcare system in both public and private settings, and she’s also the CEO of a network of over 90 GP practices in the UK, called Primary Care Research Alliance.
Thank you, Daphne, for taking the time to join me today. I would like to ask you first about the Primary Care Research Alliance you’re working with, your role, what you do, and whether you can tell us more about what you’re doing in terms of clinical research.
Daphne Hazell: Hi Olga, thank you very much for inviting me. It’s a pleasure to speak on your podcast. The Primary Care Research Alliance is a UK national network of research-active primary care practices, and we also have a few community trusts and a hospice as members. So it’s an organisation that brings together all the research going on in the community, outside of secondary care.
We are a single access point to primary care for sponsors and CROs, and we connect GP practices with them as a network. So it’s a unique way for people to access primary care.
Interviewer: That’s very interesting. In fact, I have worked on a clinical trial with GPs and family doctors only once, and that was years ago. I remember it was very successful. They recruited quite a lot of patients, but I think the industry is not aware that GPs can do that, so the natural place to go is normally the hospitals in secondary care. I think part of the problem is that they all know GPs are very busy.
And that’s why my second question is whether you think the GPs you work with and the people you’ve been in touch with have an interest in clinical research.
Daphne Hazell: Yeah, there’s huge interest. Actually, it’s interesting that you think the perception is that GPs are too busy for research and don’t want to participate, because I see it from the other end. GPs really want to do clinical research and are struggling to get the studies. They want us to come and bring them the studies in primary care. Quite often, studies are written in a way that would be much better delivered in primary care but end up being offered to secondary care sites and struggle there.
Across the country, the GPs are offering huge patient numbers to sites. This is because GP practices are getting bigger, and there’s a government initiative to expand numbers. Some sites are offering 200,000 to 400,000 patients, so even for quite rare diseases, they can get the patient numbers required for studies, and they often have research nurses working full-time in practices, ready to take them on. So I think there’s a big gap between the perception of what primary care offers in terms of clinical research and what primary care actually offers.
Interviewer: I agree, because as a member of an Ethics Committee, we sometimes discuss the information to be sent to the GPs and say, ‘Do we need to send that to them? They’re very busy.’ and so on. I agree with you that it’s really overlooked, and maybe we’re not very up to date in the industry on GPs’ interests.
My other question is, what do you think in terms of capacity? Do you think the GPs have the experience and capacity to run clinical trials? I think that’s one of the major concerns when it comes to selecting sites. Sponsors always want to make sure that the site has the capacity to conduct the clinical trial and the experience. So what is your view on this?
Daphne Hazell: I think that’s a really crucial point – capacity. I think that perhaps past failed trials have put people off. And I think that is one of the absolute reasons of existence of the alliance, to make sure that when sponsors come to us with feasibility for a study, it’s data-driven, but it’s also based on knowledge of each practice, their strengths, their resources, what the setup is, what the physical spaces are like. Some studies need more physical space, and some practices are tight on space.
And what they’re currently doing is getting to know our members inside out, so you don’t just get data-driven feasibility for your trials. And I feel like that’s where things start to go wrong, and you need to get the right sites in primary care for your studies.
Interviewer: I completely agree. I think one of the biggest challenges when it comes to capacity is that GP practices have enough resources. We always want someone to be a backup and things like that.
So do you think that’s possible when you work with GP practices, to have a backup and really have that kind of emergency contact if needed for the research?
Daphne Hazell: Yeah, that’s the standard practice. Most of our practices will have a backup. They often cross-cover. So the Principal Investigator (PI) from one practice is added to the delegation log of the neighbouring practice, so that they can provide that backup.
And the same goes for research nurses. They can sometimes cross-cover, and most practices will have a whole batch of research-trained nurses, so that even if only 2 or 3 are research nurses running a study. You always have drama when someone’s on leave or goes off sick, then there are some more nurses with GCP training who can just step in to back up. I think that has become very normal in general practice.
We’re quite used to working with crises and staffing, and I think it’s really important that this is made clear at the feasibility stage for sponsors, so that they have confidence to engage in primary care.
Interviewer: That’s a good point, and it’s really good to hear. How about access to facilities? In some clinical trials, they might need an X-ray or something else, and it’s not something you would naturally have at a GP practice.
Is there any kind of collaboration between the GPs and other centres where they can use some facilities and have access to them? Because that’s always been a tricky point, especially for radiology. If you need any radiology facility, there are waiting lists and so on.
Daphne Hazell: That is an interesting one. And the workaround we’ve got is that some sites are co-located with radiology facilities. They may be in some sort of community building that includes community diagnostics, and quite a lot of ultrasounds, X-rays, and diagnostics are done in the community anyway, so it’s surprising how many sites are co-located.
The other one we recently looked at was securing national contracts with local private hospitals for radiological diagnostics, and that actually worked really well. The practices then referred patients to private hospitals for tests and scans, and the patients were then back in primary care, which worked really well and took the pressure off the NHS system as well.
Interviewer: It’s great news to hear that you have that option. I hope more people will be aware of it now that we’ve talked about it. My other question is about the interest. What kind of studies will be of interest to the GPs? Do you think they’ll be more interested in observational studies or real-world evidence? At the moment, real-world evidence is very popular in clinical trials.
They are also decentralised clinical trials, where you can have a physician in one location and patients spread all over the country. Do you think there are any preferred indications in general? What do you think is the interest when it comes to research from the GPs?
Daphne Hazell: I think the interest is vast. And I think that’s one of the great things about primary care, that many practices have their own interests. My personal interest is wound care. So I know which practices and sites have wound care, and I would go to them with a wound care clinical trial because I know they love it and they’re set up for it. And I think that a lot of practices can do any study, but if there’s a niche speciality, then we know who they are, and I think that’s really crucial to get the right person.
We’ve got doctors with special interests in minor surgery, ear, nose and throat, and ophthalmology. All those clinical trials can be done in primary care if you’ve got the right skill set there, so it’s just a matter of seeing what’s available.
The demand to take part in clinical trials is huge; the practices are always contacting me. They really like real-world evidence. The changes in the drug tariff have meant there’s a lot of lower-level evidence, so not clinical trials, but lower-level evidence generation, case studies and case study series, going on in vast numbers now, which is very exciting. Primary care loves doing that as well because it benefits patients and keeps everyone busy, active, and enjoying research.
Interviewer: It’s very interesting to hear that people have their preferred specialities in the areas where they want to work. So it’s not like when you say a GP, I think many people think they don’t really have any speciality, but as you said, they’re people who are interested in different fields and have experience in different fields, so that’s very good information to have.
So, what do you think, and what do you see as the challenges in conducting clinical research within GP practices? What do you think is something we need to tackle in terms of challenges?
Daphne Hazell: I think the challenge I see as a GP is that protocols are often written internationally. So they may not be designed with primary care in mind, and it’s sometimes difficult to make them suitable for primary care. It’s difficult if they’re multinational clinical trials. Even when they’re UK trials, they’re sometimes not written with any GP input. When you read the protocol, you realise that if you had only asked, we could have made this much easier for you. So that’s frustrating, but you can get protocol amendments, can’t you?
And I think, with the GPs, the challenge is getting enough work. They want to do more. They really want to scale up and get properly engaged in commercial clinical research, yet the volume of work is not flowing through, even though it has increased in the last few months, which is great.
I think there’s a slight hesitancy among sponsors and CROs to engage with primary care. They might find it held at arm’s length, and it can be hard to get through to practices when you’re trying to talk to people. Until you’ve got the inside track, which we provide as the alliance, and I think that’s very helpful, with people’s phone numbers and WhatsApps, then suddenly it’s all very accessible and easy. But I think that first step of engaging with the general practice is difficult and can be very slow and time-consuming for sponsors unless they know the right ways in.
Interviewers: That’s very interesting. I think, particularly about the point of the protocols, I completely agree with you. In the majority of cases, the people involved in writing the protocols are not GPs, and they’re not from primary care, so they have a different type of mindset, if you want to put it that way, and they tend to create protocols which are more suited to secondary care and hospital settings rather than GP practices, so I completely agree. When you have a protocol like that, you look at it and think, “Well, that’s probably not really appropriate for primary care; it has to go to a hospital.” I completely agree that this is a big problem we have in terms of protocol writing.
Do you think something could be done about the second point on contacting GPs? Do you think there could be a centralised way for people to submit feasibility, for example, and then have access to the GPs? Do you think that’s something that could work to make it easier?
Daphne Hazell: Yeah. So we do that with a quick turnaround. Many studies don’t want to wait 3 or 4 months, but the National Institute for Health and Care Research (NIHR) takes sites promptly and wants to start looking at sites in the next few weeks. So that’s what we do.
They come to us and say they need 10 sites for this protocol. We’ll have a look. We don’t generally go to all our members. I just look at the long list and find the right ones for each study, so they have a sort of handpicked list of sites from the 100-200 choices.
I’ll probably only offer them for 10 sites, because if I know the right ones, they don’t need to look across the whole country. Yeah, it’s just a different way of finding sites, but it seems to work for sponsors who definitely want to get going.
Interviewer: I think it’s a perfect way to gain insights from someone who knows the sites, their interests, and their experiences, so that’s a great benefit when selecting sites.
I think that in many cases, we just shoot in the dark and see who we’re going to get. And we don’t always get the best sites in terms of resources, and there are plenty of challenges when it comes to selecting sites. It’s not that the investigator is not good, but sometimes the whole setup of the hospital and how things operate might not be the most “user-friendly”, let’s say it that way.
Daphne Hazell: Yeah, absolutely. The protocols are exciting. Even yesterday, a sponsor came to us saying they wanted to get our members to run a couple of practices to comment on their protocol, just to make sure it was workable. So I feel like things are changing, people are coming a bit earlier with protocols.
Interviewer: So, basically, you offer that service as well. If someone wants to consult with you, they can just approach you, and you’ll find someone who is a specialist in that, such as some of the GPs, who can provide the feedback. You offer that as well.
Daphne Hazell: Yes.
Interviewer: That’s brilliant. I don’t think many people know that, so we need to tell them. My last question is about the benefits of using primary care and GP practices in clinical research. What do you think are the biggest benefits of using primary care?
Daphne Hazell: I think for the patients, it’s near their home, with familiar staff and a familiar location. The volume and the speed with which they can start a study make it so much quicker to contract with primary care.
We have studies that can be set up at sites in 2-3 weeks from the first contact for very basic ones, and in 6-8 weeks for the complicated ones. To be honest, the thing that holds it up is the MHRA time, not the set up time.
There’s no doubt it’s fast, it’s good for patients, it’s good for the doctors, and they want to be doing it. They want it, and they want their patients to have the opportunity to participate in research. There are no real downsides to community primary care research.
Interviewer: I think it’s a very good point that fast setup is critical for many companies, and that a familiar face is also important because you don’t want people changing all the time. You have the same person, and they probably have better oversight of patients than in hospitals, where you have constantly changing different people. Yeah, so I think that’s a really great point about the benefits of the primary care that you gave us.
So what we’ve learned from Daphne today is that there is great potential in primary care and many services are available. If you’re interested in conducting clinical trials in primary care, you should definitely look into it as an option, because support and resources are available to help you if you are planning a clinical trial that could be suitable for primary care.
