Trials with Maya Z

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Hello, everyone. Welcome again to Trials with Maya Z. Today, I have a dear friend of mine, in my next episode, Carol Scarfton. She's not only a dear friend but also a patient advocate. One of the advocates that I've been following for quite some time, a real force of nature. Carol, you're involved in many initiatives doing a lot of things. So can you just present yourself and tell us a little bit about yourself?

Yes. Thank you Maya. Hi everyone, I'm a long-time patient advocate. I've been running an organization now for 10 years for chronic and rare diseases. I'm a person with a multitude of health conditions myself. I don't have a rare disease as such, but I do have rare bone anomalies, rare gene mutations, and other rare qualities that make me as a person rare.

And I don't actually sit under any umbrella per se, but I do have many other friends and contacts within this space who also, sit under that same complex umbrella and we do actually work a lot to try and advocate for changes to help people with complex lives as patients. We also worked a lot within the space for clinical trials, the Pharmaceutical industry, medicines development, patient engagement, health literacy, and basically anything that's going to make patient lives a little bit better.

That's super important, Carol, and I witnessed when we started FindMeCure, you were probably one of the first people that I met in different meetings to raise the patient's voice. And I know how dear to your heart this is because you're doing it for yourself.

You're doing it for everyone else. I know how much, you've supported other people to start their own things as well. , Carol, I mentioned to you that in my podcast, we're speaking about what makes or breaks clinical trials. And so far I've been bringing primarily clinical experts, like clinical research experts, or let's say, different technology leaders.

And it was about time to really bring the patient's voice so to speak. I wanted to ask you, where do you see clinical trials and patients? What are your observations today?

I think it's actually vastly improved and I have to say that I think that the COVID pandemic has altered that because people took part in COVID trials, for instance. And I've noticed within my own community now when I'm posting things about organizations who are running trials, because a lot of my members have fibromyalgia, there's a number of different, types of trials going on.

It's not just the same old standard uniform type of trial. A lot of different sorts going on. And they're actually getting involved. They're interested, which wasn't there before. Um, you know, You don't want to thank the world for having a pandemic, for bringing that forward, but it's actually tweaked interest in people to actually get involved in research, which is something we've been supporting as an organization since we began, getting involved with and advocating for people to get involved.

Yeah, I agree with you and I also have to admit that I've seen this shift in mindset when it comes to clinical trials, at least more people know about it, they have heard about it. So that's definitely positive. What about access to clinical trials? Do you think it's changed?

It's a bit difficult that one really when you think about it because it depends on the trial and it depends on what you mean by access. Because, if it's a remote trial, it's going to benefit any patient. It's going to benefit the caregivers, the families. In the UK it's a bit different to the likes of some places in Europe, where you have to travel hundreds of miles to get somewhere. Or if you live in America, where you're travelling thousands of miles to get to a site location. Here in the UK, it's different, you might have to travel 300 miles, maybe it's down to London, from up north or go travel up north to Edinburgh or something like that.

But it's still a hindrance when you think about fatigue and you think about time and expense. But I'm not actually 100 percent sure yet whether or not it's improved. Um, because data's starting to filter through. And all this talk about decentralizing trials and things because there are lots of different ways that people are trying to approach it.

I don't think that a trial could ever really be 100 percent remote. I think there's always going to be an element where you're going to have to be attached to the trial site. Yes, you can speak like we are now video calling and teleconferencing and things like that.

There's no reason why meetings can't happen, but physical things like testings and scans, can still be done a lot easier without a patient traveling to a trial site. Because, even here in Sunderland, there's an MRI unit. It's in a mobile van.

You could technically have mobile units that go to locations.

So yes, maybe a patient still has to travel, but not as far to, say, where a trial site is. Because you could, a mobile location might go to a specific city. So they might maybe, what, travel 30, 40, 50 miles instead of traveling 200. I don't know. But for access, I think it depends. We speak of access from that perspective, but when you speak about access about whether or not you're talking from the relationship with doctors and whether or not doctors are putting forward the idea of clinical trials I'm not so sure whether that's happening Because a lot of the trials that I'm putting forward are coming through social media.

They're actually coming through newsletters from organizations and companies, or they're coming through social media itself. And I dare say as well, that the last few, there are a number of them posting on Facebook, where communities actually exist, which is what we've been saying for years now. You know, that's where communities are.

During your initial surveys, you get them in, you attract them in, and you're weeding out the people who are no good for the trial during that survey at the beginning.

Yeah. Maybe it's not a hundred percent, but you're right. It's one way to do that. One area of access is whether can you actually participate with the schedule of the trial or let's say the location of the research center?

Would they fit your schedule, your lifestyle, your disease even. But the other access is exactly do you even know that clinical trials exist for your disease and how do you identify this clinical trial? From what I'm hearing most of the time you actually understand that through social media and advertisement. Okay, so it hasn't changed much.

It seems that way to me at the moment from, that's just through observation. But, I mean niched communities, especially within the rare disease space find out through different means when it comes to what trials and things are available or what's going on. Social media are just a part of that.

They're just a part of the pathway. But we all work together as a community. So... If something crosses my email feed

and it's suitable for one of my colleagues from a different community, then the first thing I'm going to do is forward and it's going to go.

Because that's how we operate as communities. I mean, you've got to scratch each other's backs and help out. You are always going to know somebody who's going to be in need of something, or somebody who knows somebody who knows somebody.

Exactly.

It's about networking, isn't it? At the end of the day.

Absolutely, Carol. But what about companies? Are they proactively coming to you saying, Hey, we are starting a clinical trial in this area? You have this network, for example, would you share information on the clinical trial? Do they come even one step further? Let me ask you to contribute to this question.

Do they even come even earlier before they've even started the clinical trial to ask you what do you think, where should we engage with the patient, who should we ask, what they think, and so on and so forth.

It's not true for me on a personal level, but I know from organizational levels that companies do approach organizations with respect to clinical trials and for people getting involved. Whether or not They're doing it at the right time is always the question that I have at hand and as you know me, I advocate strongly that patients are involved right from the get-go from trial design.

So, I mean. Are companies doing that? Probably not so much, not yet. But I think it's changing. I do think that it will happen more as time goes forward, but I don't know whether or not companies are I can say that, you know from speaking within the actual

hmm.

charities, the likes of the fibromyalgia charity, get approached about studies, uh, and whether or not they're coming from academia side or pharmaceutical side, but they certainly get approached about studies and trials.

And I know that probably the Elos Danlos one is very similar for that as well, where you will get approached. It might not necessarily be a big, massive pharma company. And I think that's the vision when you ask that question do companies approach? That's the vision that you have in front of you is oh my god is Pfizer getting in touch Is AstraZeneca getting in touch or but it's more likely to be some tiny little company.

um, Because I'm in the chronic pain space, the musculoskeletal space, a lot of the trials that are coming our way are all to do with the kind of cannabis-related drugs, for instance. So there are a lot of them that are very small.

But you also have to make sure that they are legitimate. So you might be getting approached, but are they real? Are they something that is worth doing, or are they scams? I don't want to say scammers, and I'm trying to think of the right, the right term, but you do get approached. You get approached sometimes by people who maybe aren't who you should be accepting to jump on board with.

And I think that sometimes there might be a bit of desperation with smaller communities to actually jump on board these things to get involved. And then, down the line discover that they really wish they hadn't. It might end up costing them money, and things like that. sometimes it's like where you end up doing more of a product review, but it ends up costing you a lot of money.

Actually, that brings me to my next question.

How do you assess if one company is lazy? Like, I would assume that it would require at least some time on your end to actually research and ask here and there. You also mentioned something else, which was very interesting. You mentioned that they may, end up regretting that they started in the first place because they don't like what they hear. It means that they will have to transform their initial ideas a lot. And that will contribute to the budget. So are there any similar challenges when working with other companies?

Like, I'm not speaking only about the big companies, but in general.

To be perfectly honest, you've got to think small because you're not talking about big companies here. It's got nothing to do with big companies from where we sit within the big grand scheme of things,

You're dealing with a lot smaller companies who are trying to find new treatments that can help manage conditions or they're developing devices even, they're not even developing drugs, they're developing shoes that help people with musculoskeletal problems or balance.

It could be anything. So I think it really depends on when they bring patients in. I mean, for me, a lot of research goes in. If I, get an email through and somebody's asking, we would like to get in touch with you to discuss collaborating on such and such, the first thing I do is check the validity

of whether or not they are a real entity because before you know it, you've been hacked and your data's been, you know, it's like, you've got to be careful because

there are a lot. of scammers out there. And I don't know what it's like for other people, but I experienced this a couple of times of a week.

I get these kinds of emails and I am checking them.

Why would I want to collaborate with you again? I'm not really sure who you say you are and it's an email it says reply to and the email address isn't even the same name as who it's signed the email at the bottom and it's dangerous so when you're thinking about companies it and the smaller companies it's more complicated.

To assess whether or not they're real. Because they're not one of the big companies. It's a bit different if you've got one of the even mid-sized companies contacting you. Because you know they exist. You've got a bit of an idea. You've seen their name in the news. You've read articles about the things that they're doing.

But with the smaller ones, you've never heard of them before.

That's, uh, like advice for them really, like do your homework and make sure that you present some information before you send your next email and make sure there is a, like a link to the company or publication or something like that.

I want to bring you back to, a topic that we just started, I think. Again, access to clinical trials and how do you get information about clinical trials from your perspective Carol? What's the ideal way for a patient to receive information about the clinical trial?

I mean, there's like yourselves, the widgets, and the companies and organizations, like Find Me Cure for instance, and also, be part of research and IHR and things signing up. You know, for, this kind of things.

Is important. I, do believe that if patients signed up more and, recognized that these things existed, they would have a bit more success when looking for trials because I think a lot of people are expected just to land in their lap. They don't seem to realize that they have to do something as well in order for it to come to them.

They can't just sit there and wait for somebody to go, oh, here you go. Here's a trail. They've got to do something, you know. themselves, haven't they?

I understand Let me challenge you here because it's kind of like controversial. On one side, the entire industry is screaming patient recruitment. It's super hard. We need patients, et cetera, et cetera. And on the other side of what you're saying, we need to, like, patients need to be more proactive.

Actually, a few weeks ago, I was, having these intense interviews with, different patients, with different cancers, diseases, and, probably 100 percent of them, let's say not 100%, but a very high percent of them did exactly what you said, they were proactive, they were searching for information, either through a friend, Or through a community or through some like general Google search and like the internet in general.

Most of them said the doctor didn't even discuss this option with us. So I understand what you're saying, but is what you're saying because we lost hope that doctors can be more involved? Or is it because you really believe that the ideal scenario is being more proactive?

Both is the answer to that. Because I do believe that there is a percentage of patients who believe it'll just fall into their lap. They can just sit back and wait for it to turn up. But, that doesn't just apply to patients, that applies to so many different things, doesn't it?

But doctors could be doing a bit more. I do believe that Surgeries, in my opinion, right, Should have a member of staff Who, even if they only worked one day a week, Sat there, and, Was attached to the surgery that dealt solely with this. So they weren't, a doctor that was seeing patients for their illnesses and diagnosing and all of that.

But they were there specifically to help patients get access to clinical trials. I think if surgeries could have somebody in the surgery that did that, then that would help. But it's always about the one, it's always about funding and financing and whether or not practices can afford to do it.

But if there's a large population of patients attached to a surgical practice, then surely it's beneficial. To do the research within your own practice to see where, especially when it comes to cancer, a lot of trials exist within the cancer space, let's be fair. Okay. And a lot of um, studies, happen within the diabetes space.

The percentage of people with diabetes has gone through the roof. So you would think that they would start to look at it differently instead of putting the focus of the main GP that I go to see, say, um, to find out about my, health, them looking for it. But for somebody else, Make a new position within the practice for somebody to actually have that role.

So somebody could actually contact the practice and sit down and talk to somebody who knows, about the clinical trial space.

Yeah, yeah, exactly. People can be more proactive in searching for trials if they know that trials exist. And you're right. COVID improved that a little bit. So people know what clinical trials are. More or less, let's say, but that still doesn't mean that a lot of people will actually know that this can be an option.

They wouldn't know how this exactly works, how do they find the right one. So, yes, they can be more proactive, but at the same time, we also need to continue working towards better education. Anyway, Carol, can you remind me, have you been ever part of a clinical trial yourself?

yeah, a very long time ago.

Um, for a medicine, yeah, when I was 15, for an acne drug, believe it or not. And I, I don't, I love to talk about this because when people complain now, they should have been on a clinical trial like 30 years ago. For one. My mother had to translate what the doctor was saying to me because he had a broad Glaswegian accent and I couldn't understand a word he was saying.

And my mum just thought I was being belligerent, but I wasn't. I really couldn't understand. And I was only 15, so I couldn't understand anything. All I knew was, okay, sign, there were a few disclosures, like, only being 15, there was a problem, like, if, getting pregnant.

Um, on this strong, which spun my mum in an absolute tizzy because I was only 15.

Yeah.

And they wanted to put me on a contraceptive because, of that, obviously, I was only 15, so there was all of these disclosures and thing. I mean, it was completely different. And, then you get signed and then you go and you follow the procedure and I was taking it, it was like four months I took this drug for, so once a month I would go, they would test my blood, and, but that was it.

I mean, and then when I'd had taken it, that was it. I didn't hear anything else about it, nothing.

Did anyone come back to you, and tell you, this is what happened? And, okay. Do you think now this is improved, Carol? What is actually better today with clinical trials, in your opinion?

Well, you get to read about things, a lot more than you certainly did. For me, the only way I got to find out that this drug went to market is because however many years later, when I was at university, one of the people in my flat was taking it.

Oh, wow.

And I said, I was on the trail for that. And they were like, wow. Yeah, exactly. And I, thought this is, you know, but that, how I found out. So it's a bit different. I do believe it's different now. I know that there's still a big shout for companies to improve that feedback loop and, I do think there's room for improvement. I think that they could still do more.

I do actually believe and stand on this heavily. That if they implemented that, engagement structure, right, at the start with patients from child design, then they can embed it into the culture so that the feedback loop is there right throughout. You're not necessarily going to be using the same patient.

In trial design, as you are as a participant for the trial, it's going to change. Your patients that you're engaging with will change throughout the whole process from beginning through all the different phases. It's not going to be the same people. But if you have this at the start, then you're already getting that feedback loop out there.

But you have to translate it in a way that everyone can understand it. I'm not being funny, but for me, there's this, way that everyone seems to think that even everybody who works within that clinical trial has an understanding of what everybody else does.

But they don't. I mean, that's not necessarily true.

So it's not even just about the patients who don't understand things and need to know. Your sales team, for instance, could do with knowing what's going on at the beginning. Irregulatory people should be there at the start. So for me, yeah, I know, and I haven't said this yet, and you're probably actually surprised I haven't.

But that multi-disciplined approach where you have all your different stakeholders involved. It's not just about patients. So for me, has it changed? Yeah, it has because that is changing very slowly. But I do think it's going to change more because I believe that there are more and more initiatives and toolkits now that are being developed to help guide these things into place to make it better.

And, for me, yeah, you know, in the future, yeah, I believe it's going to improve drastically. all you have to do now is look at plain language summaries, for instance. That's how they're feeding back this information. I mean, it's getting recognised now,

Yeah. But Carol, actually the plain language summaries and also you mentioned the regulators. Actually, that really cries for my next question. Do you think that the only thing we need to accelerate this change and let's say make it like a change in clinical trials, it can be only accelerated like the speed can be improved only if the regulators have a strong position there? Hmm.

I think that the regulators are the ones who are best placed to help make the changes that are necessary.

And it's not that they necessarily decide what changes, but those decisions come from a group that, you know, what needs to happen to fill a gap that's causing a problem from something from going forward, for instance.

I mean, who are the people who don't just write the policies, people should be the ones who are also helping to campaign to make changes. This is what I believe that regulators are supposed to do. I believe that they're not just there to sit there and create a list of do's and don'ts of what goes on within a trial. You were all, if you want to make the most efficient trial, you have to prevent as many bottlenecks from the get go, because that's what costs you money. It doesn't just cost you money, it costs you time and it costs you energy. So, your patients can help you in essence. All of your stakeholders can help prevent a number of bottlenecks because you can see them so far. I have an affinity to see bottlenecks before they come. it's natural. But not everybody has that affinity to be able to spot a bottleneck. But if you have a group of stakeholders, And they're all sitting at the beginning, and you're building, and you're sorting out the design of it, and you're sorting out all your protocols and everything, you know, for what the trial's going to be.

Somebody in sales, for instance, is going to be able to spot them early enough. What regulation needs to be put in place by the time that they're trying to put this to market?

Um, and I mean, these for me are things that most patients aren't going to be sitting there thinking about.

Yeah, of course. They will come with a different perspective. You're right.

Patients are thinking about um, how are they going to access this drug after the trial? Are they going to get this drug after the trial? Or are they just going to be taking this drug during the trial and then get told that they can't have it?

Um, they're the questions they're asking. They're the questions that they want answers to.

But there are other questions as well. Carol, there are other questions that should be asked. You're speaking about the drug after it gets approval. But what about the drug or therapy or medical device or whatever during the clinical trial, the patients will be the ones to see the bottlenecks around.

The location like how far they're willing to go. The procedures, their frequency, the type of requirements, the type of expectations, all these types of things that will actually help you understand which are these must-haves. In your clinical trial, so that your patients feel empowered and engaged, and they continue to contribute with their participation.

So, not only the market actions, but even before that, patients can bring this perspective, but I agree with you. It shouldn't be only about the patient's perspective. It should be about a multidisciplinary perspective, like all stakeholders. Coming and discussing which are all these bottlenecks, scientific, operational, and everyone, everything else that we can actually predict and work up front to actually overcome them and we can continue this conversation forever.

You're fortunate to know how, and I have plenty of questions, but we need to wrap up. So I have only 1 last question for you. If there is 1 thing that, um, that can improve clinical trials, what would that be?

It's not so much, that this is possibly going to sound a bit, off the beaten track but for me, it would be the introduction of, mental health support to the clinical trial protocols, not just for the patients who are actually taking part in the trials, but for the caregivers, because the caregivers are going to need that mental health support. Probably a lot more than the actual patient who's taking the therapy.

I think that is the biggest thing, the biggest change that needs to happen right now.

Carol. Thank you so much. I would just add that probably this applies not just to clinical trials, but also to any normal treatment. For everyone listening, Carol is attending multiple conferences and doing a lot of initiatives.

So you can connect with her and learn even more about the things that she learned, throughout her career. Again, Carol, thank you so much. It was really an inspiration for me.

Thank you very much for inviting me, Maya. It's been a lovely experience to sit here and record my first-ever podcast.