Trials with Maya Z

Maya Zlatanova, TrialHub (00:00)
Hello, everyone. This is Maya, your host. And today I have a guest that is actually coming for a second time on Trials with Maya Z. But there is a reason for that, a reason that makes me very passionate in the past couple of months. I decided to start a mini series on standard of care, why standard of care is important for clinical research.

in any decision making around clinical research, life sciences, and so on and so forth. And why we're starting with Carol. Carol is a passionate patient advocate, a patient herself, someone that is not only passionate about the thing that she's doing, but she's not only speaking, she's actually doing stuff. She started the organization, Sletters and Sletters.

I'll send you the link to that so that you can also follow. Carol is on every conversation with pharmaceutical companies, with patient advocacy groups to raise awareness and actually bring practical advice. How we can make research and pharma more practical, more helpful, more efficient. And that's why Carol.

And Kara and I, we had this conversation in the past about why it's critical for the researchers to understand the patient journey before they start even thinking of clinical trials. And standard of care, I want to start with how do I understand standard of care? And I'm happy to hear what Kara will say, but to me, standard of care defines the local patient journey to a big extent.

Of course, the patient journey is defined by multiple criteria, like the socio -economical status, the demographic profile of the patients, the country itself, and so on and so forth. But these are lot of things that are being considered when also defining the standard of care of any indication in any country out there. What is basically accessible? What treatments, what procedures are accessible? What are the timelines, the waiting timelines?

the information flow and so on and so forth. Everything's basically defined by the local standard of care. And this standard of care defines more or less the experience of patients throughout healthcare. And the conversation with Carol today is about how the standard of care experience differs to clinical trial experience and why we should even consider

understanding better standard of care before making any decisions on how we should position, how we should plan our clinical trials. So, Carol, starting first with my first question, how do you understand standard of care from a patient perspective? How would you define it? Yeah, how would you define standard of care?

Carole Scrafton, Flutters & Stutters (02:48)
From a patient perspective, how do I define it? A standard of care is, it's about access, but it's not just about access to a treatment, it's about how that access happens. It's about who's involved with that access, how long that access takes. I mean, sometimes outside the clinical trial space, standard of care, access to medicines, even just simple basic medicines isn't easy.

Maya Zlatanova, TrialHub (02:59)
Hmm.

Carole Scrafton, Flutters & Stutters (03:17)
when you're taking that into consideration and then looking at clinical trial space and the potential of having access a drug via a different means, it might be better to take that route than to continuously not get access to that basic drug that's available all the time. But it is a lot about how you're treated. It's about

You are treated as an individual during that journey. How people, it isn't what they see you as. You are not just a disease or even a person. That drives me mad when people go, hey, I'm a person, I'm not a patient. It's a lot more complex than that. It is, you're right about when you're taking social determinants of health into consideration, that is your standard of care.

because everything has to be involved with that, the delivery services of how you get that. Does a person have a network of people to care for them, whether they are outside or inside a trial? Because if they haven't got that network before a trial, and you expect them, and you just assume they've got a network, then they might end up dipping out of that trial as a result. Or they might not

Any notice of your trial? I mean, for me, I have no network as of a continued state of people there to back me through something like that. I have people I can call on, but that's not a care system. So you have to take this into consideration through trials as well. And there are a lot of people when they talk about trials, they talk about caregivers, but not everybody has that.

And it's not right to assume that they do. And also, not everybody going through the trial process is a child. I'm talking about people like myself who's an adult. And adults don't have the same lifestyles or home ground as a child that's going through a trial. So it is a very different journey.

Maya Zlatanova, TrialHub (05:26)
Yeah, exactly Carol, and I would assume, not all assume, but here are assumptions, you're absolutely right, we shouldn't assume. It's more my experience that every single indication, every single disease, every single disease defines also some characteristics of how you experience standard of care, how progress your disease is another story.

But let's go to a practical question, Carol, because I know you've been exactly in such a situation. Your doctor comes to you and suggests to you, hey, Carol, there are two options here. That's the established treatment. That's what I would prescribe you according to standard of care. there is a new clinical trial, a great opportunity for you. How would you behave in such a situation? How would you compare?

these both options

Carole Scrafton, Flutters & Stutters (06:21)
Well, in my case, it was very different because it was a case of what's the most, what's the one that's going to keep me alive. So, so, so for me, and it was, there was actually about four options, but there was only one, which was the clinical trial. But having been diagnosed with non -small cell lung cancer, adenocarcinoma in the lymph nodes.

and not being able to have surgery, I was very limited to the treatments that they could give me. Radiotherapy was the prime treatment and I just opted for short -dose chemotherapy to go alongside it, which boosts the effect of the radiotherapy. It's not the main treatment at all. It literally is like a third of a dose once a week for six weeks. And after that,

because I had the right biomarkers, they said I could have this immunotherapy treatment. And that's what we decided. But then I got a phone call one of my oncologists to explain that because my sliding hiatus hernia, which was nothing to do with the cancer, was sliding into my chest.

It was causing a problem and there was a problem with respect to the radiotherapy because the radiotherapy is a little bit targeted. They tattoo dots on you so they aim it and everything. They might end up causing damage to my esophagus, to my hiatus hernia. So they offered me a couple of options and one of those options was to pretty much have that same process.

but to have the immunotherapy treatment alongside at the same time as having the radiotherapy and the chemotherapy. But I had no idea whether or not I was getting the treatment or not.

Maya Zlatanova, TrialHub (08:15)
wow.

Mmm, yeah.

Carole Scrafton, Flutters & Stutters (08:22)
So for me, it was a case of, I go along what we've already decided with a slightly reduced radiotherapy regimen because of the hiatus area? Or do I go for the trial and go for the best? But I had no idea whether or not I was going to get the chance for this immunotherapy treatment if I had had a placebo.

So for me, that was really quite wrenching on the brain because it is a matter of life. Lung cancer is not the best. No cancer is good, but lung cancer is definitely not one to mess with. And because mine kind of began in the lymph nodes, it doesn't matter what size it was, it was an automatic stage three cancer. So for me, it was really bad, but I opted to go for the original.

decision that we made and I mean I'm gutted because to say no to a clinical trial goes against everything I believe in but when you are in that situation you can never you cannot say for certainty what's going to happen or what situation you are in at that time and for

I just couldn't make that decision. And I think, you know, for other illnesses, in specific, I think that's always going to be the case. People are, if it's a life and death situation, people are going to choose the route that's going to keep them alive most. If a trial is likely to give them reason for life, they're going to choose the trial because they likely don't

Maya Zlatanova, TrialHub (10:00)
Mmm.

Carole Scrafton, Flutters & Stutters (10:02)
have a treatment available that can help sustain them whereas I had that option. So for me I was lucky but also I am gutted that I couldn't contribute to research but you know I valued my life option more I'm afraid.

Maya Zlatanova, TrialHub (10:14)
Yeah.

Yeah, well, in these circumstances, I think that every single person, with very few exceptions, will prioritize your life, your quality of life as well, because here, like you said, it's a matter of living or dying. And contributing to research is absolutely like amazing opportunity. But then again, having to choose between these two options, it's hard. It's very hard. And your true inspiration, Carol.

a fighter, in real example, like I said, you walk the talk, you not only preach that, but you only teach and preach, but you actually do it. But I wonder, Carol, if let's say that if you had another alternative that is provided by already reimbursed options, established options, and you're still offered clinical trial, then how would you decide on

How would you decide whether you go after the clinical trial or you choose the more, let's say, approved and established treatment? What would be the decision you're going to

Carole Scrafton, Flutters & Stutters (11:26)
I think that is basically where I'll be in six months time. It is because the what happens next, because that is a conversation obviously I haven't had with my oncologist yet. But I know that when it comes because cancers, it doesn't matter if the immunotherapy and the treatment, in my case it has shrunk it.

Maya Zlatanova, TrialHub (11:33)
Mmm, okay.

Hmm.

Carole Scrafton, Flutters & Stutters (11:55)
And in my case, you know, things have been going good, but in six months time when the immunotherapy stops, you know, you don't know what's going to happen beyond that. But if I get, so it's different. So for me, it's a case of I'm more likely to probably go on and choose the trial in six months time in a year's time than I was back in November when treatment hadn't quite begun yet.

And I think that, you know, going through treatments already and having a bit of experience with those treatments helps make that decision. It does for me, I'm not everybody, but for me, you know, going through the care system and the approach that I've gone through with different hospitals and everything also helps. And if a clinical trial can provide me with that same standard of care that I have received

the hospitals who have been providing my treatment now, then yeah, but I would want to make sure that they had that in place because the standard of care I have actually received through my treatment so far has been 100 % beyond. So they would have to match that for me to say yes, because I live by myself. So, you know, I have to ensure

Maya Zlatanova, TrialHub (12:58)
Hmm.

Mmm.

Mmm. Yeah, that's very interesting, Carl.

Carole Scrafton, Flutters & Stutters (13:19)
All of those things are in place.

Maya Zlatanova, TrialHub (13:21)
Yeah, that's very interesting, Carol. So let me ask you another question then. If you're offered a clinical trial, but you have to change your doctor, would you go for it? Yeah, you will. So the doctor, the doc. Okay. So the doctor is not the most important thing, but what is the thing that you're there? You want to do a compromise because you mentioned that the clinical trial should match at least the, like the care that

Carole Scrafton, Flutters & Stutters (13:34)
Yeah. Without a shadow of a doubt.

Maya Zlatanova, TrialHub (13:51)
you've got from the standard of care. So what are these elements that are absolutely must otherwise you can't proceed with the clinical trial.

Carole Scrafton, Flutters & Stutters (13:59)
This might sound a bit pretentious, but it's not, it's not pretentious and it's not meant to be. But for the first time in my life, and it shouldn't be this way, but having multiple chronic conditions and living with those for decades and going through what I did as a patient for those decades and being treated like...

Maya Zlatanova, TrialHub (14:03)
Mm -hmm. Okay.

Carole Scrafton, Flutters & Stutters (14:26)
It didn't exist, these didn't exist, everything was, you know, was all in cause because of trauma and mind and mind over matter, all of these different kinds of things. Getting cancer, the first time that everything has been taken into consideration at once. So my whole health has been looked at holistically for the first time properly.

And I'm 50. So you can imagine how long I've gone. And then sitting down and sitting with friends and going, ironically, I'm now getting the health care I've been advocating for, you know, last God knows how long. But it's because I've got cancer. And that is not how it should be. And at the end of the day, when you go for a clinical trial,

Maya Zlatanova, TrialHub (15:09)
Yeah.

Carole Scrafton, Flutters & Stutters (15:20)
or whatever illness you've got or you're getting that, that level of holistic care should be there. It should be there to make sure and ensure that your other conditions are being nurtured as well, not just the one you're on the trial for. Because at the end of the day, you can't discount those. Those conditions are also contributing to your health, the one that you're on the trial for. You can't ignore them. It's as simple as

So if you are designing a trial, you must remember to actually acknowledge that. It's important. Otherwise, you're missing a big chunk of that patient. There's no point. I mean, this is what we are advocating for as patients. I'm not the only one who's advocating for it at the end of the day. If a person's condition comes along with it, it's not even a case of fatigue.

Maya Zlatanova, TrialHub (16:11)
Yeah.

Carole Scrafton, Flutters & Stutters (16:17)
You know, there's a whole host of things, skin conditions, migraines, a whole host of things that people, you can't ignore these things. You must remember that they might need a level of care to make sure that they can deal with those and the side effects that they might get from the trial as well. It's all got to be taken into consideration.

Maya Zlatanova, TrialHub (16:41)
And that's exactly where this alignment with standard of care should come in to understand what people different stages of their disease progression are going through, what type of specialist they're meeting, what is the likelihood of them having other chronic diseases or other side effects like you said, and knowing that, and the thing of this, this differs very much country by country.

because in some countries there is one pathway, in other countries there is another pathway, but you're absolutely right. And even if we speak about cancer, to be honest, we have a lot to do there to approach cancer more holistically, but that's a topic of another big, that's another big topic, that's another big topic, definitely. I wonder also, Carol,

Carole Scrafton, Flutters & Stutters (17:20)
It really is!

Maya Zlatanova, TrialHub (17:27)
Because we were discussing what motivates you to join the clinical trial and how you're comparing standard of care with the clinical trial, which are these must have things within the clinical trial so that you can feel welcomed in the trial. it kind of matches at least the minimum that you're getting from the standard of care. What

staying in the clinical trial, especially when we speak about longer clinical trials that take months and months and sometimes years to be completed. What would be the motivator there to stay in the clinical trial? And I would add one caveat. What if a new treatment is being reimbursed for the same disease while you're in a clinical trial?

Carole Scrafton, Flutters & Stutters (18:13)
you do throw these challenging things into the mix, don't you, Maya? I mean, go to the, you know, before you throw that into the mix. You know, I don't want to sound like I'm repeating myself, and that's along with millions of other patients, but...

Maya Zlatanova, TrialHub (18:18)
Well, that's the reality.

Yeah, okay.

Carole Scrafton, Flutters & Stutters (18:36)
That whole feeling of being included and involved really does drive people. I mean, I know some people would like to get paid for their data and some people want... I mean, for me, that's... I mean, my data is helping to improve something that I'm happy, you know, but give me a drug at the end of it. I want the drug. If the drug's going to help me...

control, know, at least give me the drug at the end of it. That's what, you know, I want. But if there's a drug, like you said before, earlier on really, about if there's a drug that's already gone through that and it's available and do you want to stay on the trial? Well, that's competition, isn't it? I don't know how I would deal with that actually. I mean, if I was already on a trial...

and a drug was approved before that trial finished it would depend on the level of disease I think if some people were really desperate they're likely to because I can't speak for myself at this point but for me if people were at a real serious level of their disease then they are possibly going to ditch the trial to go for it to try and get the one

that's already approved and the one that's already been reimbursed.

Maya Zlatanova, TrialHub (19:58)
Mmm, interesting.

Carole Scrafton, Flutters & Stutters (20:00)
I really do think it will depend on need and necessity from a health perspective because if you haven't got as much of a need you're not going to have as much of a desperation for the drug.

Maya Zlatanova, TrialHub (20:16)
like motivation. Yeah, yeah, interesting. So can we say that clinical trials for patients are yet another care option at the end of the day?

Carole Scrafton, Flutters & Stutters (20:26)
think so. think, I mean, like every area of healthcare, there's an abundance of things that need to be done to improve it. But I think that it is because no, I hate these cliches, but it's because there is no one size fits all for humans, people, we are all different.

And I know, said this when we've spoken people with the same disease are all different. They're not the same. So people's needs need to be collected properly right at the start. And I know I'm gonna keep saying that actually. I'm not really bothered about repeating that. Because if you want...

it to be as perfect as possible then you have to do it succinctly with that person's needs it doesn't matter how many people you've got on that trial if you're not meeting those specific needs then that person's not gonna gon they're not going to be as interested in hanging around

as that really, isn't it? I mean, it's basic.

Maya Zlatanova, TrialHub (21:41)
Well, it sounds simple, Carol, but we all know that applying this rule is absolutely complicated. Political trials in general are complex creatures and customizing them for the sake of meeting individual needs is very, very difficult. I wonder though if we can find some balance, maybe not individual needs, but let's say

Carole Scrafton, Flutters & Stutters (21:48)
I know.

Maya Zlatanova, TrialHub (22:08)
group needs or let's say even country specific needs, which is actually my next question. Carol, you're based out of the UK and you're very well familiar with your standard of care, healthcare system. But I know that your organization is truly global and you are going to all sorts of events where you meet a lot of your patient advocate friends.

some of them fighting same challenges like you do, same disease like you do, same disease like you do. So what's your observation? Is the standard of care between different countries much different? Do patients in the different countries go through completely different journeys? What's your observation?

Carole Scrafton, Flutters & Stutters (22:50)
Oh, um I think the answer is Yes

Maya Zlatanova, TrialHub (22:53)
Yes.

Carole Scrafton, Flutters & Stutters (23:19)
across the board for everywhere. Healthcare systems are different from one country to the next. you know, I think, you know, as patients and as organizations within industry, we all know that we all understand and I think we're all starting to respect that now. I mean, we know that it is different. So you can't have

one set of rules. If you did have one set of rules that the globe could use it would be amazing. But whether or not that is possible to actually build, well I'm not so sure whether it is to be honest. it which is sad because I think that there must be at least one set of rules that we can fit within all the guidelines of everywhere. Like a standard you

People talk about gold standards for this and gold standards for that. But when the systems differ so much, like they do with healthcare, I think that that is why there is so much difficulty in order to be able to provide these frameworks. I mean, people are building frameworks now within industry, I think, you know, to...

try and counterbalance all of this. But I don't think it's going to be possible to do it at a global capacity. Will it happen at a global capacity? I think there's going to be a lot of, there's got to be a lot of lobbying, you know, to get regulations changed and I can't see that happening anytime soon.

Maya Zlatanova, TrialHub (24:54)
It's not only like regulations. Yeah, it's not just the regulations, Carol. It's how much different countries and populations can afford. At the end of the day, that's basically what lies in the fine local standard of care. What can one nation afford when it comes to health care coverage? And this unification that you speak about, it's a dream.

Carole Scrafton, Flutters & Stutters (25:05)
Yeah, exactly.

Maya Zlatanova, TrialHub (25:20)
Maybe it's not, be honest, because in the ideal world we would all settle with one standard, but it's the best. But that's not that easy. And if we have one standard, but it's, let's say, ultimate, let's say it's not the best what's available, just so that everyone can afford it. That sounds a little bit like a communism type of thing in health care. And I don't think anyone wants to achieve that.

But anyway, I want to ask you for advice. Imagine I'm planning a clinical trial and I need to work on my protocol, need to work on my eligibility criteria, I need to work on my schedule visits and so on and so forth. What would be your advice to me to understand better what patients are going through and how am I to take into consideration their standard of care? Do you have any advice for me?

Carole Scrafton, Flutters & Stutters (26:14)
Talk to the patient.

Maya Zlatanova, TrialHub (26:15)
to the patient. Thanks Carol.

Thank you very much. Carol, you again brought a lot of interesting perspectives, also practical advice, practical insights. Talk to the patient, maybe it's the least practical because I know firsthand how much the industry is struggling with that, but let's hold that together. We'll find better ways.

to empower more conversations between patients and industry. Thank you so much for your participation once again, Carol, and good luck with all you do.

Carole Scrafton, Flutters & Stutters (26:48)
very much for inviting me to join you again, Maya. It's fantastic as always.