In the latest episode of Precision Neuroscience Reimagined, Tina was joined by Mike Seneviratne, Clinical Director for Research from Rotherham, Doncaster and South Humber NHS Trust, as they dive into the challenges and solutions in mental health research. Discover how patient engagement, UK-focused protocols, and streamlined processes can revolutionise clinical trials.
Tina: It’s a pleasure to have you here. first of all, let’s dig into what on earth is going on in the research landscape. We know from our perspective that a lot of pharma companies are now trying to move away from the UK because they say it’s just too difficult to recruit patients and too difficult to have trials. We also know that, of course, the local pharma really want to have trials here and we know that, from the government perspective and George Freeman, we’re trying really hard to make the UK become a life sciences super hub.
From your perspective, why is it so hard to run a clinical trial in the UK?
Mike: Well, that’s a big question to open with, for multiple reasons. There’s no one easy answer to this, but thinking about recruitment particularly, the NHS as a whole organisation has very, very limited resources and they’ve been chipped away at over the years. Clinical work in itself is difficult enough, and I think there are lots and lots of very, very busy clinicians who would love to be doing research. The amount of clinicians that we’ve got even in RDaSH who want to be doing research, but struggle to get the time to do it because of the clinical work.
It’s so overwhelming, and we’ve got too few clinicians. There are far too few nurses, and far few doctors working in our services, so they’re trying to do the job of multiple people as well. I think it’s a bit of a perfect storm really, meaning, that research gets pushed to the side even though I think, deep down, people do know that research is the way to develop new technology, new therapies for patients.
Do you think that it’s seen as a nice-to-have on the ground?
Mike: Yeah. I think that view has changed a little bit because of COVID, because I think that did help to get people thinking, “Oh, actually, research is going to save us here,” and it did and people have recognised that. The massive response to the callouts for COVID-19 vaccine participants is good evidence of that, but I think there are still quite a lot of clinicians and hospital managers who think, “Oh, that’s nice for other people to be doing, and we’ll just watch and see what happens.”
As I say, if you spend any time with a clinician manager to really explain things, they get it and they want to be doing it. As I say, I have got people, thankfully, knocking at the door saying, Please, can we do some research?” It’s fantastic, but then freeing up their time to do that-
Tina: To do so, that’s a different matter, isn’t it?
Tina: So we’ve got the issue for the clinician’s time, so how do you think we’ll actually be able to bridge that gap because that’s not going to go away.
How can we become this life sciences superpower with the pressure on the clinicians?
Tina: There still will and always will be that pressure on the clinicians, unfortunately.
Mike: It’s about doing things maybe a little bit differently.
Tina: So, typically, they would have to do it by hand?
Mike: Yes, there are reporting systems, but they’re fairly crude and, certainly in mental health services, not that many patients have a hard-coded diagnosis. You’d have to troll through the notes to find what the diagnosis is.
It’s incredibly time-consuming when you’ve got caseloads of thousands of patients. It’s just not feasible. That’s a full-time job for somebody just doing that. If they’re trying to at the same time see those patients and provide that care, it can’t be done.
Tina: That’s one aspect.
What other aspects could be sped up?
Mike: Again, thinking about what takes time with these things, so thinking about the very beginning of deploying a new study, training is a good example. We were on the journey of signing up for a study, and the training was going to take at least two full days of online videos. I actually did block off that time in my diary to just sit and watch these videos, and it was very, very, very dull to the point that actually how much of it’s really going in? Probably very little, and I’d be referring to the manuals afterwards.
Tina: Yeah, but then if I’m being devil’s advocate, what would happen if they didn’t provide the two full days of training?
Mike: Absolutely. It was self-paced, which was good, so you could do it in drips and drabs, but I just felt I needed to do it that way. Yeah, you need to know what you’re doing with a study. You have to be able to deliver a study safely and scientifically, rigorously, so absolutely appropriate. I think there are certain things where maybe…
Tina: Was it all appropriate? Was it all necessary?
Mike: I wouldn’t say it was all completely necessary. I think it would be necessary to see that for the complete study, but there’ll be certain people doing certain aspects of the study where certain bits of the training are relevant. For example, how to ship lab samples, it’s not something I’m going to be doing, but, as a PI, I needed to look at all of these videos so that I had an awareness of it which again makes sense because, if I’m taking responsibility for the conduct of the study. There’s an element of “I trust my colleagues to do their jobs properly”. If they were to watch those videos and do that training, I trust that they’ve done that. If there were issues, well, that’s what you’ve got a CRO there to help, who’s monitoring what you’re doing and you have monitoring visits, checking that everything’s being done properly.
There’s never going to be a perfect solution to cutting out all training, but I think it could be done more smartly. In addition, though, I do wonder are there any kind of training passport that you could create. I know there are, some of these do exist. Certainly, within drug companies, you’ve got alliances with certain CROs as well. There’s certain training that stays on our log and that’s fine, but having a bit of a passport for “I’ve done my”, whatever, “assessment training” if it’s like a PAN scoring, “I’ve done my PAN scoring, that’s done. There could be other examples like that especially, going back to the lab processing samples thing, if there are similar things.
Tina: That’s really interesting because, in your standard typical corporate world, there would be a record of all of the training that you’ve done.
Mike: Oh, there is for the NHS. I’ve got one mandatory training. As I said, I’m aware there are some attempts to do that for research, none that I’ve been able to for any of the research projects we’ve done. So it’s something that definitely could be if all the big pharma companies, for example, got together and say, “Okay, we will accept this, this, this, this training program,” and if people have done it, uploaded their certificates to an online portal or something, it’s how it works for the NHS. I’ve got my mandatory E-learning that you go through and it just stays on your record, and then you don’t have to repeat it until it goes out of date. Perfect.
Tina: I think that’s a great idea, and this is a call-out for pharma who are watching this from Mike and I to develop something like this. One of the questions that I’ve had before is can we find out from our NHS what can be done to help them with clinical trials to make it much smoother? This is clearly something that can be done to help with clinical trials to make them smoother in the UK. I think that’s a really great idea.
Do you have any others? What else are the real blockers with the clinical trials?
The training is one. We need to slim that down so that we don’t have two days of training for something that you might not need to do. Let’s make it relevant to the relevant people.
Mike: Also just not making it relevant to the relevant people, but trying to trim down some of what’s in there as well because some of these videos are very, very long. It feels like they’re just ticking a box themselves to say they’ve delivered that. Tick. Done.
Tina: Sometimes, as marketers, you do go on and on a bit.
Mike: Yeah, we’ve touched on participant recruitment as well and the difficulties of identifying participants, but then I suppose, when it comes to running the study and having things, you’ve opened the study, you’ve got your first patient in, and then one of the things that we have struggled with in the past, but it’s entirely variable, is the CRO. We’ve worked with some fantastic CROs and we’ve worked with some terrible CROs, and that can make a huge difference to, A, team morale because feeling supported by your CRO, having that good, responsive communication is really essential.
We’ve just done a COVID-19 vaccine study, and it’s ongoing, but all the recruitment’s ended now. The CRO was brilliant, really, really helpful, really responsive. If we had a quick question, bam, they would get back to us the same day or the next day at the latest. It felt collaborative, and it worked well. Funnily enough, recruitment went really well and it was a great study. Obviously, the ongoing bits are still ongoing, but no problems. We’ve had no issues from the CRO, no major issues with our site because we’ve had that collaboration, to begin with to get it right in the beginning. It can be really tricky when you don’t have that responsiveness because it might be that you’re maybe not doing something quite right, but because you don’t know that you’re not doing it quite right-
Tina: You don’t know what you don’t know.
Mike: Exactly and so it carries on.
Tina: If somebody isn’t responding to you or if somebody is responding in a difficult way, why do you want to help them?
Mike: Exactly, but then, equally, it then comes down to-
Tina: It goes down to human nature, doesn’t it?
Mike: Exactly, and then, when it comes to the data cleansing at the end they realise, “Oh, hang on a minute. I need to go back and redo all of this and get the participants back in to redo a certain bit because it wasn’t done in maybe quite the right way,” it’s just time-consuming. It’s annoying for the participants to have to bring them back in some time to do bits, and it is entirely avoidable. There’ll always be bits that go wrong in the studies, but if you really put that groundwork in at the beginning and have that good communication, you’re going to eliminate 90% of that.
Tina: Okay. We’ve got a couple of really good, tangible things there, and one is the training and a really nice training platform with a joint certification as we have for so many different things, but we need to have it for the research landscape. Then another is the really good relationship with the CROs. That’s absolutely key.
What else is it that you think that pharma specifically could do to help you with a clinical trial? When you get a protocol, how does that feel, that process when you’re looking at it?
Mike: Yeah. They’re very American-focused, and the protocols are often, you read them and you go, “Okay. Yes, this makes sense in America, but maybe not here,” and we have to kind of do a bit of mental juggling to see, okay, how does this fit in with, A, our clinical services and, B, just our processes for research as well because there’s, obviously, quite a big difference.
Having UK-focused protocols would be really helpful. I know that the UK is a diminishing market for pharma companies, but something like that would be really helpful and, hopefully, wouldn’t be too much legwork from their end to make things a bit better.
Tina: To change the labour.
Mike: Part of that could involve actually coming and talking to services, doing some really good PPIE work. Come and talk to us. How does mental health care get delivered in the UK? How do early intervention clinics work? What’s the flow-through of patients? I actually had somebody from one of the drug companies recently get in touch to go through exactly that, and it was really lovely because you could see they wanted to deliver.
They want to understand how it works because they have a huge role in developing new therapeutic processes as well as drugs themselves, but the process around that drug, especially mental health where it’s not going to be just one drug, it’s going to be a drug maybe alongside a therapy at the same time, so they’re going to really drive that process forward, and having them engage and say, “How does it work already?” really helpful.
Tina: Tell me then, and again I’m going to put myself into the devil’s advocate hat:
If I’m pharma and I’m developing protocols for the US market and I’ve got the market on top there, why on earth should I bother trying to come to the UK?
Mike: I can see what they feel and what they mean by that because, certainly, it does seem to be the research landscape is tailing off a little bit in the UK, but it’s a world leader in healthcare still, the UK. In terms of our position with the data that we collect because, again, with most trusts, and certainly in mental health, being on electronic records, we’ve got rich data sources now as well for doing, A, the participant identification, et cetera, but also the longer-term follow-up, looking at actually the medications being prescribed, what’s the real-world outcome of that, and doing that proper real-world research post-market research is ideal.
Tina: That’s where the NHS number is a real nugget, isn’t it?
Mike: Oh, it’s brilliant.
Tina: I also haven’t told him to say that.
Mike: No, but it is. It’s an amazing resource. I think the UK is starting to wake up to the data side of things as well with the development of the national SDA and sub-national SDAs.
Tina: Let me ask you then.
Do you think that actually they’re missing a trick by not coming to the UK?
Mike: We want to do the research.
Tina: Because they’re developing medications without having the true understanding of the patient’s history and the long-term outcomes.
Mike: Exactly. We’ve got all of that data. We’ve got very, very well-developed and well-understood clinical pathways. We’ve got NICE that says, “This is how you should deliver care for this particular condition across the country.” It’s universally designed. Well, it’s designed to be as universal as possible. Yeah, I would say that, in terms of if you want to come and test your new drug and you want to work with great academic institutions that are here, we have great NHS organisations with a good track record of delivering high-quality research, the UK is a no-brainer. It just needs to get its act together when it comes to doing more.
Tina: Yeah, and I think that that’s where the entire ecosystem is really important because it is not just the NHS alone, it’s all of the providers and the life sciences community because, as you’ve said right at the very beginning if there’s a way that we can speed up training to make sure that it’s relevant to each particular person and to streamline that whole process, and that’s something that pharma can absolutely help with, then that will help the NHS which again could drive more value.
Let me ask you about patients and their involvement in clinical trials:
How do you think patients feel about being involved in clinical trials?
Mike: It’s a mixed bag. There are huge differences between different groups of people as well. It’s a shame that, still, your typical research participant is White, middle class, university educated, and that’s missing a huge amount of society and, particularly, a huge amount of society that has a greater burden of disease. COVID, again, really highlighted this when it came to the vaccine rollout, but there’s a lot of suspicion around organisations and big, The Man as it were, the government, the NHS, trying to inject me with something. There’s lots of suspicion there, very understandably given some historical issues, but that’s why it’s really important to engage everybody.
I think that’s something that, RDaSH, we’re quite good at. We’ve got very well-engaged patient research ambassadors who’ve been brilliant in helping us access, I hate the term “hard to reach” because I think that puts the onus on other people, people we fail to reach, communities, for the likes of prison… Doncaster has got five prisons.
Tina: I did not know that.
Mike: Yes, again, prisoners are a massively under-researched area. Thankfully, that’s something we’re trying to address, and there are networks like the PORSCH network that try and address that, but, again, a lot more could be done, things that the Emory Network, again, are trying to address that, and that’s fantastic. I think it is slowly, but surely going to change. It’s going to be a long process. It’s not quick. You can’t change that overnight. That’s something that you have to actually sit down with people, discuss research, discuss why it’s important, and discuss how it could help them and their communities. You have to put the legwork in to do it.
Drug companies can do that as well. I mean, we do that as an organisation. Drug companies can do that when designing studies. PPIE is obviously very well-developed here in the UK probably more so than in many other countries actually.
Tina: Just to clarify for everybody what PPIE is?
Mike: It’s Patient Participant Involvement and Engagement.
Mike: That’s so key. If you’re designing studies with the participants that you want to be involved in, you’re going to design a study that they then want to get involved in. It’s a no-brainer.
Tina: When you say, “Design them with,” do you mean that they should actually physically have a meeting with them?
Mike: Well, that’s the ideal. I know that that’s not always very practical but then talk to the organisations that do this. Again, we’ve got a strong PPIE engagement team at RDaSH. Come and talk to us, and we’ll help you talk to people. We can take questions on your behalf and talk to the people that we know. It’s so key, because designing studies to work for the participants, that’s one of the biggest barriers when it comes to recruitment. It’s a lot of effort for people to get involved.
We’re asking, especially in today’s climate of cost of living crisis, we’ve got ongoing problems from Brexit and COVID still, loads and loads of difficulties and loads of pressure on people’s lives, and then if these people are also suffering with their mental health at the same time, like we were talking about with staff earlier in terms of how have they got the mental capacity or physical capacity to engage in research as well, and we’re asking a lot of them to do this, and it’s no surprise then that a lot turn around and go, “I’m not interested in the study.”
If you design a study to make it as easy as possible to be a participant in, your recruitment is going to be better.
Tina: When we’re talking about patients and the economy and the pressures on everybody, how many of the studies take place where they could go in the evening or the weekend?
Mike: Well, that’s a really good question, and what we’re seeing is the rise of lots of private research sites who’d often do that. Now, evening and weekends, it’s something, again, as an NHS organisation, I’d love to be able to offer that, but then you’ve got to find the staff for that and you’ve got to match that. Yes, I’d love to be able to do that and make it as convenient as possible and, fine, we’ll work a little bit late into the evening to try and do that, but you can’t ask that of staff without then having to-
Tina: No, not when they’re already under a huge amount of pressure.
Mike: It’s difficult, but, yeah, that would be ideal, doing it in people’s homes. I think it’s not just necessarily about the timing. There are ways of doing things a little bit more cleverly, such as more remote assessments, and remote capacity consenting, which do get used in some studies, but we could do more of that, so maybe some more of the asynchronous assessments as well. Instead of having bloods and needs assessment, maybe you could also do it where you have the assessment and then the bloods and just try and work it around. There’ll be limits to that in terms of making sure the scientific quality of the study is still there, but where you can allow flexibility, protocol says you have to see this person within a window of two days for follow-up in six months’ time.
They might be on a holiday, and then it’s a practical deviation if you see them outside of that. We’re just being practical. I think there’s an element of realism that needs to come into that as well. I understand that there’s complete scientific quality that needs to remain. Otherwise, what’s the point of doing the research, I think we’re a little bit too far and this has to be done in this incredibly rigid way.
Tina: It’s too rigid.
Mike: It’ll be different for different studies, but yes.
Tina: It’s been actually really interesting and enlightening speaking to Mike today to understand more about what can be done from an NHS perspective because we always talk about and we always hear that pharma are moving away from the UK because it’s so difficult but what can actually be done to help move those clinical trials into the UK.
As we’ve talked about and as we are all really aware, the unique identifier of having the NHS number is what truly will make the NHS the superpower, because there’s nowhere else that gives that cradle-to-grave information. It is just so unique and so powerful. There are a couple of real nuggets that Mike talked about that can genuinely help with research in the UK, always at the forefront and, as we’ve been talking about in many of our podcasts, we’ve been talking about putting the patient first.
Mike, thank you very much. I’ve really enjoyed speaking with you.
For this episode of Precision Neuroscience Reimagined, and more: https://spotifyanchor-web.app.link/e/fJhEepfIhFb OR you can find the full episode on our YouTube channel: https://youtu.be/20_49AG1ihk?feature=shared