The future of research: Challenges and solutions for participant diversity

Episode 2 of the NIHR podcast series discussing the big research challenges facing healthcare, hosted by Dr Sanjay Ramakrishnan, Research Fellow in Respiratory Medicine at the University of Oxford . Every week, UK clinicians with experience of research discuss the tough questions about research.

In this episode,  Sanjay is joined by research optometrist Laura Taylor,  Sofia Cerdeira MD PhD, clinical lecturer at the University of Oxford, and Dr. Tanya Baron, an emergency medicine consultant and former GP, to discuss why it matters that research participants are diverse, the challenges to achieving this, and ways these might be overcome.

The views and opinions expressed in this podcast are those of the host and guests and do not necessarily reflect those of the NIHR or the Department of Health and Social Care.

Transcript

Sanjay Ramakrishnan  00:00

Welcome to this special podcast series from the National Institute for Health and Care Research about the future of research. You'll be hearing from five clinicians who are the current Thames Valley and South Midlands Clinical Research Network fellows. We will be discussing the big research challenges facing healthcare. I'm Dr. Sanjay Ramakrishnan. I'm a research fellow in respiratory Medicine at the University of Oxford. And over four episodes, I'll be asking my colleagues the tough questions. Are we getting trial participants who are representative of our diverse population? Is our research workforce ready for the future? Is it all going to be online? Join us to get answers to all these tough questions.  The title of the podcast today is The future of research: Challenges and solutions for participant diversity. Diverse communities are exactly that, diverse, and this includes all groups within the NHS core 20 Plus five framework. This framework includes the most deprived 20% of the national population, additional underrepresented groups such as those from ethnic minorities in five clinical areas requiring accelerated improvement, such as maternity. To discuss this broad and exciting topic, I'm joined by Laura, Sophia, and Tanya. So, to start with, could I just ask each of you to introduce yourselves to our listeners?

Laura Taylor  01:20

Hi, I'm Laura Taylor. I'm a research optometrist. I work at Oxford Eye Hospital, and I see patients with inherited retinal conditions, who are taking part in clinical trials. My research work involves improving the vision tests used in those ophthalmic clinical trials.

Sofia Cerdeira  01:40

Hi, my name is Sofia Cerdeira. I am a clinical lecturer at University of Oxford and a doctor at the John Radcliffe Hospital. I look after pregnant women and I have a particular interest in maternal medicine. My specific area of research is pre-eclampsia, which is a disorder that causes raised blood pressure in pregnancy.

Tanya Baron  02:01

Hi, I'm Dr. Tanya Baron. I'm an emergency medicine consultant at Oxford and I've also previously been a GP. I'm involved in various trials within emergency research and chair a patient and public involvement group. My passion is to make research accessible to everybody to ensure it's a normal part of patient care.

Sanjay Ramakrishnan  02:21

Thank you. So today, I want to talk about what the challenges are and why it matters that all participants are diverse. As always, COVID is a great example, the COVID vaccines were an incredible success of research, design and delivery. But one issue that came up was the participants who join the COVID vaccine trials were not representative of the wider UK population or the wider global population. One important group that was missed and often missed are pregnant women. And Sophia, you can tell us why we are not as good at recruiting pregnant women and include these important group of people in our in our studies.

Sofia Cerdeira  03:01

You know, classically this is a major problem. Women are denied investigations, or lifesaving treatments simply because they are pregnant or breastfeeding. And the truth is that we don't have appropriate research and appropriate data to be able to care properly for those patients. So that you are aware, just to put this into context, there are more drugs in the pipeline for rare diseases than there are for pregnancy. And if you think about the amount of pregnant woman in the world, per year, this is something that is actually needed. This is breath-taking, it shouldn't be happening. And it represents about only 3% in comparison to researching cardiovascular disorders. And if you think about the impact that pregnancy has not only for the mother and the long-term health consequences there has in the mother, but those nine months in the womb, they will be responsible for imprinting what's going to be the life of that baby becoming an adult increased risk of cardiovascular disorders. So if we can intervene in pregnancy, there's, you can significantly improve the condition of the whole population. And that has been a problem because, yeah, Laura, I think you want to say something.

Laura Taylor  04:34

I've got a question: what is being done to try and improve pregnant women's involvement in research?

Sofia Cerdeira  04:44

So now there's movement trying to change this. And this, this thing is now acknowledged as a major problem. I think that's the first thing. And there's several initiatives. And it's not only in pregnant woman but it’s also women in general. In for instance, in cardiovascular disorders, and in cardiovascular diseases, women are massively underrepresented - sometimes they're only 20 or 25% of the population that has been studied. And sometimes, there are gender differences in in the way that the disease manifests and you cannot extrapolate one for another. So, there's a campaign from the American College of Cardiology, so ‘Go Red for Women’, there are clinics that have been started specifically for women in cardiovascular disease. So, there's a lot of campaigns to raise awareness. There's a lot of Institute's that are being started for women's health, and women's research. And in general, there has been a huge movement also from the leaders here in UK specifically and you have people from like Professor Bergen light, raising the issue. And I think what's important is that there's been some work that needs to be worked with the government regulators, clinicians, academics, patients, and citizens need to work collaboratively to make this work. I mean, this, the issue of a woman in pregnant patients being underrepresented in research could be a whole topic for, just for the part that the entire podcast.

Sanjay Ramakrishnan  06:31

Exactly, just over half of the population of the UK and unfortunately are not represented in our in our trials. And a key step that the National Institute for Health and Care Research are doing is trying to involve participants and patients early on in the design. And Tanya mentioned this. How are you doing this Tanya? How are you making sure your participant population are as diverse as possible? And we sometimes forget that diversity starts all the way from just gender balance, not just the more difficult so hard to reach group?

Tanya Baron  07:07

Yeah, so we created our PPI (Patient and Public Involvement) groups a couple of years ago and have got a reasonably diverse group in terms of gender and ethnicity. However, I think with all of these groups, part of the recognized problem is that often, it tends to be the people who are not working any more so as older age group that will be involved, or people who are already involved in research. And so, one of the things I'm really keen to do with our group, is to make it more representative of our local population. So, within the emergency department, we obviously cover everybody, every person, every age, every ethnicity, every presentation. And actually, what we'd like would be to have a larger PPI group, which represents our local population. And so, one of the key goals really is to try and get some funding available so that we can expand that and make it more relevant.

Sanjay Ramakrishnan  08:18

Have you worked with the Centre for Engagement Dissemination, I think it was previously called include, but what has your experience and how is the NIHR supporting this?

Tanya Baron  08:30

So, the NIHR recognize this as a problem and have got some different strategies. So yes, they did have NHS INVOLVE but that recently, a couple of years ago, has now been merged together to become the Centre for Engagement and Dissemination. And they do recognize there's a problem with diversity and inclusion across all research and are trying some different strategies to change that. But I think actually, probably more locally, we all need to be recognizing as a problem within each of our own research areas and actually reaching out to try and get people more involved. And I think that's probably the better way better way of doing it rather than big national strategies.

Laura Taylor  09:26

I think you hit the nail on the head, I think one of the problems is rural communities and access to research. And research tends to happen in big cities, where there is a big university in a big teaching hospital and specialist centres, whereas across the country in smaller communities and rural communities, the research just isn't there. And I think this touches on the last podcast where we discussed having diversity in the research workforce and the more diversity there is in the healthcare professionals, you know, putting your primary care, GP pharmacist, opticians, if they're involved in research, then they can then get these local communities and these hard-to-reach patient groups involved as well.

Tanya Baron  10:20

Yeah, I was just going to say actually, there's a newish document from NHS England and NHS Improvement called core 20 plus five, which the NIHR will I'll assume will work alongside and that's trying to reduce health inequalities and looking at 20% of the most deprived population. And that's sort of determined by a wide range of social issues. And then specific population groups. So, some that you were mentioning there, Laura, the rural communities, but interestingly, actually, Sofia, there's no mention within those population groups of pregnant women. There is in their five parts, there's five areas to focus on. And one of them is maternity for ethnic minority groups. However, it's not across all pregnant women. So, hopefully that will start to work into it. But yeah, I was interested when you were saying that I was looking at the Core20PLUS5 sheet and it doesn't mention all pregnant women.

Sofia Cerdeira  11:29

No, but it's yeah, it's interesting, but I think the important thing is that actually, they're new task forces that have been created. And several organisations like the WHO the FDA, the MHRA are now pushing to develop strategies to safely include pregnant and lactating women in research. But as we're talking now, we all need to be part of the solution and help to build this momentum, from you know, raising awareness as we're doing now and actually taking some action.

Sanjay Ramakrishnan  12:02

So, I think let's talk solutions, we heard the problem, we need to do something about it. The big thing that the National Institute for Health Care Research is doing is the Be Part of Research Campaign. Instead of waiting for clinicians or research practitioners to approach a participant, we are encouraging direct volunteering from participants, and this was a raging success with the COVID vaccines. We had more volunteers than we knew what to do with, both for vaccine studies, as well as challenge studies. And we're still using those databases to recruit participants for research in the UK and the UK was a world leader definitely on this.  So the Be Part of Research Campaign is hoping to set up a database, already setting up a database of people who are volunteering directly onto the websites, and how, how will that change how you get to participate? Will the added new recruitment platform work for you? And how will that change the way you recruit in your trials?

Laura Taylor  13:00

I think it's great. And I think it's great that proactive patients can go onto the website, they can put in their condition, and then they can see what clinical trials are going on that might be relevant to them. A couple of the limitations of the website are that, at the moment, best of my knowledge, it only includes clinical trials that are registered on the government database, the clinical trials.gov. And also, the international standard, randomised control trial registry. So, it doesn't include smaller studies that may still be going on, but they may still be eligible, I think, am I right in thinking that's changing?

Sanjay Ramakrishnan  13:38

Yeah, again, the NHS Clinical Research Network, Network of Coordinating Centres have taken on the feedback and are using what you would recognize as the network portfolio model to try and populate their research. And that is the most up to date network, we have our data. So hopefully, that will make it a lot easier for patients to understand and volunteer for studies. 

Laura Taylor  14:06

I think it would be quite good as a way of linking up to Be Part of Research Campaign, having sort of an app-based thing or linking it to the NHS app where it looks at your medical records, and you get a notification that there's a study in your area that is relevant to your condition. You know, rather than waiting for patients to proactively look for something, you know, the information actually comes to them. Obviously, there's ethics and consent, linked in to that. But maybe that's something in the future that could be looked at. 

Sofia Cerdeira  14:39

That's a great idea.

Tanya Baron  14:41

Yeah, no, I was just going to say, actually, I think the idea of a database is fantastic. I think the idea of patients and the public being aware of what is available to them and just empowering them to come in to hospital and ask for stuff is very helpful. I think from an emergency point of view, nobody comes expecting to come to the emergency department when they wake up that day. And so, knowing that they're interested in being involved, and in some way, if that is able to be flagged up on their electronic patient records, when they come would be really helpful.

Sanjay Ramakrishnan  15:20

We could have a sticker, like you have a blood donor sticker, you can have a sticker on their driver's licence saying get me for research, I want to research! 

Laura Taylor  15:29

Another thought I have is when patients have an outpatient appointment, and you get your letter, you know, it could say on there, what studies are going on in the department with bit of information saying you may be invited, to give patients a bit more warning so that they can prepare for when they turn up. But so I think awareness is a huge thing that can help improve research involvement. But I think another aspect as well we haven't touched on yet is accessibility and making research more accessible. I've been involved in quite a few studies that have had a strict eligibility criteria. And we've had to turn so many patients away, simply because they don't fit the eligibility criteria. I think eligibility criteria is important because you need to be recruiting the patients that can enable you to answer the research question. But I think when we're designing a study, we should be asking ourselves how we can make this eligibility criteria as inclusive as possible? You know, do we really need to cut off at 18 or can we recruit teenagers, children, and things like that? 

Sanjay Ramakrishnan  16:42

Accessibility comes in so many different points, like what Laura was saying. One is accessibility of the of the product, the trial, accessibility of information, whether or not the information we're giving to the participant, potential participants are accessible. And it doesn't just the language is written in, but who gives the information. So, I always use the baby lab in Oxford as an example. So, this is a is Oxford University and Oxford Brookes University collaboration where psychology researchers, child development researchers attend toddler groups, and they sign up mums and bubs, who, who want to help with research and the way they recruit is not just by, by recruiting, returning participants in studies, we're also actively engaging in play and actively engaging in examples of what would happen in, in research in that environment. So, this is this was not very difficult for Laura or Tanya to implement in, in local environment, because it's happening. Like, like, can you think they need the care, they're coming there for the care, they have to come in for the emergency care that day. If only they could see what actually is happening, so it demystifies the whole thing about research? Sofia, how could that happen in pregnant women? 

Sofia Cerdeira  18:01

I think I mean, it's actually what you mentioned, is applicable to, to pregnant woman. And I think that is another point that is important. I think another way to increase the diversity is also to increase the diversity of the team doing the research. So, it's known that women are underrepresented in clinical trial leadership. And research has shown that trials led by women tend to recruit more women as participants. And this also takes us back to what we spoke before about having other team members, allied healthcare professionals, people in the communities, people actually who are closer to the patients who are more vulnerable patients we have. So, to be able to have, to spread the team and to increase the diversity of the team. And I think that would be a way to actually increase the diversity of the participants. 

Sanjay Ramakrishnan  19:12

It's a great point. And NHS Scotland is doing a great study looking at HIV in intravenous opiate users. And they've come up with a with a whole class of researchers, they call them peer researchers, the research data is actually collected by another current or past previous opiate dependent patient. And that just gives a whole new quality even not just the quantity, the quality of data recording is, is completely a whole other level, the honesty and the discussion around the dependency changes. So that that is a great example of how you know we can implement simple things that make a big difference. 

Laura Taylor  19:54

And that links into the research champion, where you can have a patient or a carer or a member of the public with a certain interest, or in a certain experience that can volunteer to spread the word about particular research area that seems to be linked into that, or is that right? Something that we could do more to help improve diversity. 

Sanjay Ramakrishnan  20:18

The recent TV campaign from the NIHR, looking at they call them Trial Blazers, men and women, different ethnicities, people with different abilities, putting on a blazer and saying I'm a trailblazer that that sort of thing in that links into the wider national campaign of self-identifying and self-looking for research projects. I also wanted to touch on something that Tanya will have a lot of experience with being in emergency care and in primary care is social care research. Social care, patients from social care are high health care users, but often again, they are not included in many trials, because there are various limitations or various exclusion criteria. It seems primary care will be the perfect interface to include this, Tanya. How would you change how we tackle the lack of social care patients? In our study? 

Tanya Baron  21:13

I think again, it's all about reaching them in the first place, isn't it? And not thinking is too difficult to recruit these people, I think, again, is probably similar to a lot of saying trying to find a research champion from within that group, maybe, who've been involved in research before, because I think that often, people probably just think that it's not for them, it's not something they do. And actually, they're wrong. And as I've seen, the Core20PlusFive will hopefully help to address some of these issues, because a lot of these patients who are not being included in research, and will probably be in the sort of deprived or more deprived areas, and from the 20% of the population that are sort of been targeted, I think, to have improvements to their, to their health. But I mean, it is challenging, I wonder whether primary care has a bigger role in trying to address this because they're sort of working within the primary care community, aren't they and actually probably have more contact with, with people. And actually, that's probably a good, a good sort of source of patient contact. 

Sanjay Ramakrishnan  22:42

Absolutely. So that I think also, great point, we talk about marginalised communities, we just need to remove these participants from the margins and bring them to the middle. And that has to come from us as researchers, but also how these marginalised communities in quotation marks access information. So we're getting close to the end of our time. So final thoughts from all of you, anyone? 

Laura Taylor  23:10

There was something I wanted to bring up that we haven't mentioned about accessibility, something that came up in my fellowship was about patient information sheets. And sometimes, it's a really small thing, but commonly patient information sheets are really inaccessible. For example, you know, I work in the eye hospital, many of the patients we see are visually impaired their vision is so poor, they can no longer see to read. And yet, a condition on this consent form is that I confirm I have read the patient information sheet. And these patient information sheet can be 40 pages long. My grandparents had a similar experience, my granddad was, unfortunately quite unwell. He's in the hospital all day. And at the end of the day, they've been given a patient information sheet to go home and read about a potential study. But Nan and grandad, were so exhausted, they're in their eighties, you know, they just tossed it to one side, because it was just too much for them to take on board. And I think we need to be quite mindful of that. When we're designing the study, think well, actually, who's going to be reading this? And yes, we need all the information out there, but how can we deliver it in an accessible way? To not scare people off. 

Tanya Baron  24:25

Yeah, I mean, I think I agree with Laura, I think it needs to be researched and needs to be easy. It needs to be easily accessible. And it needs to be simple for the patient to follow. And I also really feel strongly that from a clinician point of view, we need to be more aware of what's happening within our own department so that not just within our own studies, but that we can advocate for the patient and offer them all these different opportunities to be involved in research, whether somebody loves research as a clinician or wants to do it as a career or whether actually they're not that interested, they still have a responsibility, in my opinion to ensure all patients are offered the chance to be involved. And actually, that's part of the NHS constitution and the NHS constitution says that patients should be given the opportunity to be involved in relevant research studies.  

Sofia Cerdeira  25:27

I totally agree. 

Sanjay Ramakrishnan  25:29

Does it go back to our title, there are problems, there are barriers to how, who we recruit the diversity of participants. They're not the obvious things that we have. This comes to you sometimes seems like really huge communities, women are being excluded, pregnant women. And there are solutions, solutions are happening the National Institute for Health and Care Research are actively working on this with the CRM network nationally are doing different things from video information sheets to online consent forms, databases with TV programmes, Trailblazers, there are lots of different things that are being done and if any members of the public are listening to these podcasts, we really encourage you to go to our to the NIHR or Be Part of Research website and have a look and see if you can tell us what else we can do to improve what we do and how we get the information to you. And thank you again to my guests. Thank you so much to all of your listeners for listening in. Hope to see you in the next podcast as well. Thank you.

Sanjay Ramakrishnan  26:30

Thank you for listening to this special podcast series from the NIHR. If you're a member of the public interested in research, please visit the Be Part of Research website to search for studies near you that you can take part in. For health workers who want to find out more please visit the NIHR Your Part in Research website to get started with your specific research, training and research career related questions please speak to your local friendly NIHR Clinical Research Network.