Not Just Patients

Designing Patient-Aligned Clinical Trials┃Maya Zlatanova

• Caitlin and Clarinda • Episode 11

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Join us for an insightful conversation with Maya Zlatanova, CEO and Co-founder of FindMeCure and TrialHub, as we discuss patient-aligned clinical trials that consider both scientific rigour and patient needs.

Maya is a health-tech entrepreneur and pharma industry speaker with over 15 years of experience in feasibility, operations, and patient recruitment and engagement. Guided by her strong sense of empathy and love of storytelling, Maya champions patient-aligned trial design and is passionate about improving the way clinical research is conducted.

This episode highlights the barriers patients face in accessing trials, the importance of awareness and education, and the benefits of improving clinical trial design to enhance patient experiences.

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Maya:

if what was in the past from one to ten was two and you make it three, that's right. Is that better? No, maybe it's better, but is it good enough? But if you learn from the existing patients and their ongoing journeys, maybe you can do it. Five, six, seven, why not eight?

Caitin:

hi, I'm caitlin

Clarinda:

and I'm clarinda

Caitin:

and this is Not Just Patients

Clarinda:

a podcast where we break barriers to meaningful patient involvement in healthcare.

Caitin:

Thank you so much for listening today. Our guest on today's episode is Maya Zlatanova, who is going to talk to us about patient-centric clinical trial design.

Clarinda:

Maya is a healthcare entrepreneur and pharma industry speaker with over 15 years of experience in feasibility operations and patient recruitment and engagement. She is the ceo and co-founder of trial hub, though her entrepreneurial journey began with tech stars backed find me cure, a platform helping patients connect with innovative treatments. Guided by her strong sense of empathy and love of storytelling, maya champions patient-centric trial design and is passionate about improving the way clinical research is conducted. Thank you for joining us today, maya. It's lovely to have you here for our first episode of the new year.

Maya:

Thank you, Clarinda, thank you Caitlin, and it's exciting that, back on my first working day, I'm joining you for this conversation. The conversations with patients and patient communities are my favorite ones, because this is when you actually get to check where you are and where you should be heading.

Clarinda:

Great. We're excited about this conversation as well. We are going to be talking about patient-centric clinical trial design today, talking about patient-centric clinical trial design today, and we have done a few episodes about what it means to have patient involvement in healthcare in general, in clinical trials at a high level. But maybe we can start with some basics and help define for our listeners patient-centric clinical trials. How would you define them and what in a traditional clinical trial design has made them not patient-centric?

Maya:

So, first of all, I hate patient-centric like the word, the expression patient-centric, because I'm hearing this expression since the very beginning of my career, before I knew what clinical trials are, before my experience with my sister, when, before I knew what clinical trials are before my experience with my sister. When we're going after clinical trials and don't get me wrong, I do see change, but incremental change, and there is a reason actually why patient centric is not the perfect definition for clinical trials and why we shouldn't go after patient centric clinical trials. And it's a simple fact. Defining clinical trials, what are clinical trials? First of all, the purpose of a clinical trial is to actually take a scientific assumption, idea, and prove it with data that it's actually a reality, it actually works, it does what we believe it does right. So actually, if we only have patient centric clinical trials, that will be even against patients, because at the end of the day, we're starting from a science point of view, so science should be also in the center. So what I'm trying to say is that having one center is just impossible for clinical trials and you shouldn't try to think in one dimension but multiple dimensions. And that's why I prefer the definition of patient-aligned clinical trials and I can explain what I think patient-aligned means to me on a very high level, but still so.

Maya:

Patient-aligned clinical trial starts from the very, very beginning, when you're even thinking of which scientific assumption you should go after, how to validate that. For example, you mentioned that you had previous episodes on patient involvement and engagement. You mentioned that you had previous episodes on patient involvement and engagement. This is where patient involvement is absolutely critical to basically patients to scream loud hey, we don't care of how many more months you're going to add to my life, like how much more I'm going to live, but I do care that the three months that I have are really high quality, like three months and I can truly live my life, for example. So that's starting with how you design the clinical trial and what you're actually trying to prove throughout the clinical trial, but then moving towards providing real access to patients.

Maya:

Very often in clinical trials we end up chasing ghosts or like patients that do not exist, that defined by eligibility criteria that are just, these patients do not exist.

Maya:

So again, this is more tricky. It's it has to do with biostatistics and science in general, but still, providing access to patients is also to do with how patient aligned the clinical trial is with the reality of patients. And then, last but not least, once these patients join the clinical trial, how feasible for them it is to actually stay committed and stay compliant to the clinical trial expectations in terms of schedules like traveling, financial side of things, commitments and so on and so forth. And, last but not least, this is not that much to do with the journey, but I think it's just to do with what it's fair, what is ethical and should do the clinical trial more patient aligned is that it is there to be able for you as a clinical trial participant to know, actually to own your clinical trial results, the results throughout the clinical trial, basically so that you can use this information in the best way possible to make more data driven decisions or just to know where you are today. So that's, in a nutshell, how I think about patient-centric clinical trials more like patient-aligned.

Caitin:

Thanks, Maya, I know exactly what you mean about. I think patient centric firstly can be used maybe as a buzzword sometimes, and that can look quite bad actually if then it doesn't look like you're aligning your trials at all to the patient. But of course there are other elements that need to be considered, like you say, the data and the science, and whether it works or not is also really critical. So making sure that the patient is included in the thought process and considered, but not being right in the middle of it necessarily, is quite a nice way to kind of encourage that collaboration between researchers and the industry and what they want and the patients and aligning everyone's goals I mean no matter what term we're using patient-centric, patient-friendly, patient-aligned, patient-first, whatever.

Maya:

These are all definitions and whether we do it is just another story, but patient-centric in general. The reason I hate this term is because it raises expectations that are too high and unrealistic. I mean the moment you say patient-centric clinical trials to the patient community, that means that suddenly the patients and what they say are is the most important thing. And don't get me wrong, to me it is one of the most important things. But one of the most important things. There are other factors that contribute to clinical trial success that are absolutely critical. And when we speak about patients, it's not only about the patients within the clinical trials, it's all the patients, like all of us, right, and we need successful clinical trials. And for successful clinical trials we need other factors to be successful as well, not just the patient-aligned factor.

Clarinda:

So that's a really interesting and, I feel, a very new perspective for me as well, because we have for many years, like you said, seen the term patient-centric being bandied around and it is a buzzword very much and I mean I feel like I've gotten behind it. I have used it so many times in posts and everything right, and it is as a patient. Yes, it is almost like a goal that we want everything to be patient-centric and we want everything to be about us. But it's very interesting because I have worked on the pharma side as well and I understand this new perspective that it almost seems like patient-centric can mean anti-science or anti-pharma, which it's not meant to, and I can. I can see that subtle difference now between patient aligned, where it kind of means like working all together, and but with the patient in mind, and I think that that's quite an interesting. Maybe we'll even change the title of this podcast accordingly not say patient-centric trials, but patient aligned trials.

Maya:

But that's a really cool thought and again, it's not about how we call the clinical trials with what we actually do right, because in this industry, yes, there are people behind the wheel, the people that are behind the operations, the people that are behind the decisions but at the end of the day, this industry impacts all of us. We're all patients of some form and we are impacted by the efficiency of this industry, and so all of us are literally incentivized to work together as a team and make it work. So being centered around one thing is definitely not the collaboration that we need right makes sense.

Caitin:

Thank you for providing that. I think that's a really cool perspective and I think from our side, where we're always thinking about how to get the patients involved, you can almost lose sight of the rest of that as well, so thank you for sharing that. I wanted to ask Maya so this is a topic you're clearly really, really passionate and knowledgeable about, but I wanted to know a little bit about your story. So what got you interested in clinical trials and solving some of these challenges to do with patient alignment?

Maya:

so I come from a culture where, at least in my family, the biggest wealth that you can have is actually having a health, and so even when we congratulate ourselves now for new year's uh, for, like christmas, like we always like be blessed with health, like be healthy, basically. So I always knew that I want to work on something that is important to humanity and people, and health, as being like the top one thing that will make you like, let's say, happy or health, always meant something very, very, very special to me. Even in my early childhood, I dreamed of becoming a doctor. I was watching such type of like documentaries and so on and so forth, never going into medicine or pharmacy or anything like that, but still I always thought that this is the greatest impact that you can have if you somehow work towards helping other people to be healthy.

Maya:

And then clinical trials it happened very out of the blue. I just joined a company that was working in the clinical research domain, and this company opened my eyes for all the complexity and regulations around clinical research. So it wasn't purely my choice, but, let's say, something that happened to me in a way. And after that, after this company, I basically grew larger and larger network and I started being in love with all the complexities and it's almost like an onion you want to peel like one like and then the after, and then the after.

Maya:

So, yeah, I I'm very, very curious in general, but the thing that actually made me start thinking about okay, this is the thing I want to work on, this is where I think I can have a real impact was actually when my sister was diagnosed with a disease that has an eating disorder. Basically, even today, that's a disease that has no actual treatment. We went I mean, you know the story, you go back and forth this doctor, another doctor, this shaman, another shaman. You know, unfortunately, I was seeing her really disappearing in front of my eyes. At some point. She was getting worse and worse. That was for years, unfortunately. For years, I was just observing her how she's getting worse and worse. That was for years, unfortunately. For years, I was just observing her how she's getting worse and worse. Our relationship was getting worse and it was the first family challenge that we've ever had and it was the hardest thing in my life, like so far.

Maya:

And because I already started working in the clinical research space, I knew, in a way, how new treatments are being developed. So it was natural to start thinking, if there is no treatment and if we're back and forth and nothing works, maybe there is something in clinical trials. And that's how I started searching for clinical trials for her and that's where the whole saga started. Ah, if I'm the patient, I would super pissed. I mean, I'm the caregiver in this case, in a way caregiver. I'm calling a call center and they're telling me go back to your doctor, but my doctor doesn't.

Maya:

Hey, do you have any idea how you can impact the lives of at least one million people? And back then I was working already on another company but I was thinking that has impact, but it's not going to impact one million people's lives. How am I to actually do that in reality? Reality? And that's when I came up with this idea to actually support people to join clinical trials, to learn first about clinical trials and join clinical trials. And that opened the Pandora box. And yeah, the rest is a story.

Clarinda:

Thank you, maya, for sharing that personal story so vulnerably. I hope that you did find some help for your sister in the process as well.

Maya:

Yeah, we did. It wasn't a clinical trial, but we found a solution that, at least at the moment, is working for her. She got much better and I'm very happy for that. But it's a lesson that I I will never forget, because in the meantime, maybe I became a mom I have two great kids but also in the meantime we supported millions of people out there to get education on clinical trials. I know what it's like and I know there are lots of problems we need to solve.

Clarinda:

Yeah, yeah, amazing. Yeah. I think that for many of us and so many of our previous guests and so many other people we interact with, a lot of the great, remarkable things that they do start from a really personal story and usually from a very dark space where they had to really find a solution for themselves that didn't exist out there, and it's pretty remarkable that you were able to do something and create that impact for so many other people but clarinda aren't all the patient advocates doing exactly that? Yeah, yeah literally.

Maya:

I remember I was interviewing um, I'm sorry, like it's not on top of my head, like his name he's quite popular, but I'll definitely add, if we can add, something in the comments of the podcast this guy. He has multiple diseases. One of it was multiple sclerosis, which we all know it's not the easiest thing to live with, and he also has chronic pain and he wakes up every single day with pain and and he's one of the top patient advocates that I know and I'm asking him why and he's like every single day. I remind myself that I have two choices I either just have the negative things and just complain about it, or I take the negative and do something positive about it. So what I do, or whatever entrepreneurs are doing, we're just doing the same of what all the patient advocates are doing they're taking their negative experience, their nightmares, and they're turning that into a positive story so that other people can live better and can go their journey in a better way. So I admire patient advocates exactly for that, because they're much stronger than I could be.

Clarinda:

Out of curiosity, was the person you are referring to robert joyce?

Caitin:

yes, exactly, thank you yeah we've had robert on our podcast before.

Clarinda:

Yeah, we both, we both created each other saying was it all about? Yeah?

Maya:

incredible person, not only him, all the patient I totally agree with you.

Caitin:

I mean a lot of patient advocates, most of them in fact, have come from a space where they couldn't do anything and they've turned that into wanting to make sure that other people don't go through that experience and have really changed the landscape and do amazing work.

Caitin:

But I suppose you have to remember, for every advocate who's made a change, there's probably a thousand other people who have had the same experience and not, for whatever reason, had the capability or the capacity or, you know, the ability to do that, which isn't their fault at all.

Caitin:

Like everyone can deal with everything in their own way. But that's why things need to change, because it shouldn't just be that one in a thousand people, you know, make the calls to the clinical trial centers, push their doctors, ask the questions, because a lot of people would never even think to initially consider a clinical trial. They've been diagnosed with something, they've been told there's no treatments and they go home and they deal with it in their way. They go home and they deal with it in their way. So the more that we can do to make this process easier for just a normal person who goes through this, so that you don't need to put in tremendous amounts of work. Is is really cool and that's what you know advocates people like yourself, a lot of other people we've spoken to making those changes so that not everyone has to take those huge extra steps to get just what should be the standard of care.

Maya:

Yeah, and I agree. I understand, caitlin, what you're saying. The thing is that one out of thousands becoming a patient advocate and being vocal for the problems and trying to solve for other people is actually something that is quite normal, because what you're saying is that we need more people to be more vocal. Right, but I'm not sure this is really the case, because more vocal means that these people need to become more proactive and trying to basically proactively push for the system to change, because the reality is that if we live in a ideal world, we shouldn't proactively go and search for clinical trials. That shouldn't be the way we get introduced to clinical trials. In reality, the doctor is the one who should open our eyes for which are all the options that are ahead of us, and clinical trials should be one of these options.

Maya:

There is a huge discussion around. Should we make clinical trial a standard of care option? And I'm not saying I'm absolutely 100% yes for that, because honestly, I mean today I know that you have to really research well the topic. Before you're certain, let's go and like, do that. But let's say I do favor this option because if in oncology by the happens more frequently than in other disease areas. But if we all have this mentality our doctor or the nurse or whoever, basically our consultant, if they are knowledgeable enough or if they have all the tools so that they can map out all the treatment options that are ahead of us, then that will give us, as patients, all the instruments to make a decision, together with a doctor, what is the best option, knowing which are the pluses and minuses. Right, but also I want to make an amendment here by saying the doctors should map out these options for us. I don't want to actually put the bow in the hands of the doctor, because I think that even today, doctors have too much burden on their shoulders and I think it's unrealistic to expect that doctors can do everything that we're expecting from them today. It's just absolutely clear that doctors are not having enough time first of all, maybe not even have education, not enough tools and so on and so forth. But if we expect for doctors to do more, it will be just another catastrophe. So I think doctors should do less, honestly, but we should build instruments and mechanisms in some way, or maybe bring more resources, more people. Maybe that can actually contribute to the other missing pieces. So, going back to the ideal world.

Maya:

There are two major things that can truly impact accessibility to clinical trials, and I'm not speaking about design of the clinical trials. I'm speaking about if clinical trials are designed in a way that patients exist in the right place, and so on and so forth. If that's the case, then there are two other factors that can really impact accessibility of patients, and that would be access to electronic health records worldwide which can be automatically matched to all of the best options treatment options in your country, outside of your country, and so on and so forth. Then there is a big ethical question should you share what's outside of your country? But that's another story.

Maya:

So, electronic health records. And then the other thing should be all the doctors to be involved in clinical research in some form, because today we know that only 10% of all doctors worldwide are also investigators. That means that it's pure look for you as a patient to be treated by a doctor who is also involved in clinical trials, and maybe they're involved in one, two clinical trials, not all of the clinical trials, right? So if all doctors are, somehow they have a role in the clinical research and by law or, I don't know, by regulation, regulation they need to at least be involved somehow, then that will also tremendously improve the access to clinical trials. And then patients shouldn't do the hard job of searching and finding what this is and which is the most relevant one, and so on and so forth.

Caitin:

I absolutely agree with you, maya, and I think, we're saying the same thing.

Caitin:

you just said it a lot more eloquently than I did, but yeah, it's basically it's about how, as a total health care system I suppose, we can get normal average patient to become aware of and be able to access clinical trials without needing to have to push and fight really hard like you have and go that extra mile. So, yeah, I think we're saying the same thing, which is a great vision to have. So, just pulling back a little bit then around, sort of these patient-aligned trials what exactly are the benefits to having a patient-aligned trial, both for the patients who are involved but also to the people who are conducting that research?

Maya:

So, starting with, for the patients, like you mentioned, in all cases, patient-aligned clinical trials should deliver a treatment that's been truly validated with the most important things that patients are actually expecting to improve their quality of life, the way they feel, or something to do with their patient journey, because sometimes it's not a direct impact to the health. Sometimes impact is like how quickly you can get, let's say, rid of the symptoms or how quickly you can get to the treatment. Sometimes even the type of administration, whether it's a drug or it's infusion, makes a huge difference for the patient. This is, like, quite critical. When we speak about the patients within the clinical trial does make it easier for them to participate and for them to feel a lot more like participants and a lot less like I'm in the shadows and I don't know what happens, like. I've interviewed another patient advocate and she said that she's regularly speaking on the phone with different friends of hers who ask her hey, should I join this clinical trial? They decided to join the clinical trial and then they regularly call her ah, I don't know like, should I continue? I'm not sure anymore. And yeah, if you feel like you're a participant and basically you feel that you've served throughout the clinical trial, then that should be a smooth journey, at least certainly not worse than if you're on the standard of care option.

Maya:

Speaking about the industry, that's where we have even bigger, even greater impact. Why? Because the industry's clinical research efficiency is not great. We're not in a good place to be. We are quoting again very similar like patient centricity words, but for other things, like what's the percentage of clinical trials that get delayed? And that all translates to more time, more money. Yeah, probably you've heard news around pharma companies losing their blockbusters wave now and feeling, oh, what do we do now? And that comes from multiple places. Don't get me wrong, but I'm just saying that clinical research is in the center of the industry making better business, if we speak about private business, but it's also in the center of providing better health care.

Maya:

With the old demographic crisis that happens almost everywhere, we are absolutely urgently needing a different health care system. We need better care for even larger number of diseases and we need it urgently, and the only way to get that is by having more efficient clinical trials that contribute, with more successful or quicker unsuccessful let's say negative results evolving to positive results. That, at the end of the day, contributes to better patient treatment, better, more cost-efficient patient treatment and so on and so forth. So the industry desperately needs patient-aligned clinical trials and I think they know it. I just I'm not sure that they know what is the right way to achieve that, and I'm not saying I know, I definitely don't know. It's a huge puzzle, let's put it that way. But I'm just happy to see that they are making steps towards more patient-aligned clinical trials. I just fear that with the current many steps that we're doing, progress is not as big as we need.

Clarinda:

Thanks, maya. That really helps lay out where we are right now and the progress that we are making and where we need to be to some extent. But you did mention that we are making steps, so I'd love to understand what are some initiatives that are driving forward this entire vision towards more patient-aligned clinical trials? I know that you are doing some wonderful work in this space yourself. We'd love to hear about some of your work, as well as some other initiatives that are driving this forward.

Maya:

Sure, I'll start with what we are doing. So when we first started FindMeCure as a company, our first product was a platform that actually gets all the clinical trials information in real time worldwide from all the registries out there and structures it in a more digestible format which is easier to understand for patients. And then the next thing that we created was the so-called application process, which allows patients or caregivers for free to actually apply for the clinical trial and get directly connected to the investigators or nurses or the contact person of the clinical trial, or at least connect them with their doctors, for example. And this is to exactly overcome the burden of patients that have no idea what clinical trials are, what to do, who they need to contact and so on and so forth, to make the connection between patients and the clinical trials. And what we were hoping to achieve and we did to some extent was better awareness.

Maya:

But we very quickly realized that this is not an initiative for a single private company. To be honest, it's much bigger. It should be also included with governments. By the way, we did support the UK government to build their internal UK I think it was Clinical Trials Gateway, the name of it. So we're very transparent, to share our lessons learned and help other organizations, the more the better. I know many people say there should be one place where people go there. Only the reality that this is pretty hard to achieve. Hopefully one day this will be possible. But anyway, with our experience directly with patients, we realized that we've been working only on the tip of the iceberg and there is a big problem that's beneath, like in the deep waters, that if we don't face this problem, we would never be able to help the tip of the iceberg, and that's to do exactly with the clinical trials and how patient aligned they are.

Maya:

We realized that very often when the patients come to us and they volunteer for a clinical trial. This clinical trial, the design, the schedule, all the decisions that's done, deal. Right, you're trying to match the patient to the clinical trial, but the clinical trial makes no compromises at this point and the patient should make compromises, but they can't make many compromises, especially when you speak about your health condition, right, that's not something that you define. So, basically, you can't do anything about it and that's why we decided that if we start working earlier in the process, before even the clinical trial is ready, it's designed, let's say, before the critical decision making is being done, we will actually impact for the clinical trials to be more feasible, more possible for patients as well. And that's when we started unlocking the Pandora box that I mentioned, which is how do you make decisions?

Maya:

Creating, organizing a successful clinical trial Patient-aligned is one factor of the many other factors and how do you build a system? This is actually a system that I'm speaking about is our trial hub and our second product. How do you build a system where it helps you to see from all the perspectives, what will make or break your clinical trial? Because, at the end of the day, we all need successful clinical trial right, and one of our main goals and that's our priority is by, of course, helping you understand competition, landscape, regulations and so on and so forth. We prioritize the patient perspective, the patient journey. To give you an example, we are the first platform to structure standard of care analysis per country, per disease, disease, so that when you plan a clinical trial in this particular indication, you know how people are treated in every single country and you know in which country it's more feasible to find eligible patients at the stage that you need them, and you know what patients are having access to and where they will be more motivated less motivated where they actually needed more. Let's put put it that way. So these are the priorities really pushing towards these clinical researchers information and insights that help you understand better the patient. So when you make critical decisions, you take into consideration the patient's reality. Of course, we have big dreams we want to actually connect the dots between FindMeCure and then TrialHub and make sure that you have the patient's opinion and the patient's needs at your fingertips at scale.

Maya:

And we're making great progress, but I mean it's a work in progress. But speaking about other initiatives, I can see more and more companies implementing into their standard operating procedures to actually include some sort of patient focus groups before they decide on the final clinical trial protocol, for example. Is that working 100%? Probably not, but it's a step forward because before that that wasn't even the case. And another initiative which is also industry related is UPATI. This is a great initiative that actually helps to educate patients not only hey, you should speak, but how you can use your voice to impact decisions, because very often, even in small companies, in small groups of people, the biggest barrier for progress is we not understanding our own language. We speak in english, but we actually don't speak the same language, and that's the biggest problem that we actually face that we don't understand each other, and initiatives like your party, for example, is such that is definitely making a huge change in that direction. I just hope that it will be even more scalable in the future.

Clarinda:

Right, right, thank you, maya. I think that there are definitely some great initiatives. I love the work that you yourself are doing. It sounds extremely promising and I look forward to seeing how it evolves.

Clarinda:

I think that we've been talking quite a bit about aligning clinical trials, involving patient perspectives in the design, and I think that these are all very essential. My question is do we need to go further upstream, from the patient's perspective to patient education, in the sense of is there a general understanding of clinical trials, or is that a barrier to patient participation at all? Is there an awareness? So, for example, in your case, your pain point was that your doctor didn't know about clinical trials, but you did. A lot of patients don't yeah, right, most patients don't and do you think that there is enough being done on that front in terms of just breaking that wall and the fact that it's not such a big bad beast? Because I believe that a lot of patients would think that they're going to be guinea pigs of some sort and they would really not want to get involved in that in any way, unless really there was absolutely no choice. So do you think that there's room for that to be explored?

Maya:

like I said, when we started finding cure, we exactly tackled this problem make sure that people are aware of clinical trials, what they are and how they can participate, how they can benefit from clinical trials. But I do think that there are other barriers that need to be addressed simultaneously, let's say. But speaking about awareness yes, of course I mean awareness is absolutely key to making clinical trials more accessible. I believe this should start more from media and I think there should be definitely close collaboration with media, because this perception of guinea pigs also has to do with the way media speaks about clinical trials. We also saw during the covid period, if you remember, by the way, that was a great chance to actually educate people about clinical research and how important this is, and I think we did a poor job using this chance of actually making clinical research the hero of the day, but that's a different story. But I do think that after COVID, more people know about clinical trials than otherwise. Why? Because it was something that we all experienced and also it was in media all the time. Media was explaining this vaccine is in phase one, what this phase one means, and so on and so forth. So if we want to achieve some sort of like scalable awareness.

Maya:

I think there should be strategic campaigns with media, how we speak about clinical research and how we educate patients.

Maya:

But let's not forget, let's be frank, even if someone tells you about clinical research in the news or in the media and so on and so forth, unless this is something that you're interested in at the very moment, you will still not pay attention to that. So the reality is such that unless you actually need something, unless you're in a certain situation or someone close to you is in a certain situation, you wouldn't probably pay much attention to that. But let's say we can do some homework of at least having less of a negative picture of clinical trials in the meantime. So when the time comes for you to hear the word clinical trials, it's not always in the darkest way possible. And then maybe again, doctors should be more involved in these conversations around what clinical trials are happening. There usually are, to be honest, because most doctors are reading publications. They're part of medical communities, medical forums, pharma companies. They're spending huge amount of money to actually educate patients, but then they don't have the time to necessarily spend and potentially they're not the best source.

Maya:

Yeah, as well so, honestly, I I'm currently brainstorming, as you can hear. Yeah, I don't think there is a silver bullet to how we can solve awareness, maybe multiple things, and for some people we work one thing. Generally speaking try to also speak about the success stories, not only the negative stories, because I think if there is one thing that impacted the dark picture of clinical trials, that's exactly that media only speaks about the big news.

Maya:

On the negative side of things, and not the success stories which are exactly the the reason why clinical research exists in the first place right yeah, and the success stories are those treatments that save lives, right?

Caitin:

I almost feel like maybe the disconnect is that when a trial quote-unquote fails or doesn't meet its end points or whatever it is, we talk about the trial, and when a trial succeeds, we talk about the drug, exactly, absolutely like the approved drug, and maybe that's the disconnect, exactly. So you know, I've experienced essentially a life-changing drug that was made available, but people don't think that actually to make that happen, some people experience that five, ten years earlier than I did, because they bought the clinical trial so for them it was amazing, it was life-changing.

Caitin:

You know, they got it much earlier than the rest of the public did and they actually changed lives by taking that risk. But at the same time, yeah, maybe they were taking that risk because they had no other choice, you know, and I think that is difficult for someone to decide whether they are going to take that risk or not, and in some cases it's easy because it's the only choice, and in other cases it might be like this drug has been approved, why would I take a trial? So it is super difficult and I think that's why, exactly like you said, people need to be educated on what are the benefits of a trial, what could it do, and just have enough information to make that informed decision as well yeah, exactly, and I absolutely agree with you about the disconnect between clinical trials and the drugs on the market already.

Maya:

Yeah, we are doing a poor job as an industry to actually advocate these success stories, but here is also where the patients can help. I think that for the industry, especially private companies, they're super sensitive when it comes to connection with patients. Yeah, there are regulations preventing you as a company, to actually be directly connected to patients. So here's the role of clinical trial participants they to become clinical trial advocates. Right, they should be vocal about. Hey, I participated in a clinical trial and my experience was this and this. I mean I'm not saying that they should give only the pink side of the things, right, absolutely, but just speak loud about it so that, oh, if she can be a part of a clinical trial, why wouldn't I try it as well?

Maya:

Mm hmm, I think that's actually the job of the clinical trial participants to also speak loud. I think maybe what the industry can do is try to encourage them by sharing more of these news. Yeah, so we've been discussing some years ago. I hope this is the norm now even providing simple things like thank you letters for all the participants. But thank you letters is like very basic the way you educate the doctors on forums and all this stuff. Maybe there should be a budget also for educating patients and encouraging these patients to speak loud about their experience so that more people hear about oh, you can participate in a clinical trial. Next time I'm in such, that will pop up somewhere from my memory and I'll go back to this person and I'll ask what was it?

Caitin:

like, and this actually goes hand in hand with making trials more patient aligned, because if people are sharing their experience it's great, but the more patient aligned the trial is, the better those stories will be, because I know people who've been on clinical trials and not had a good time and that's actually discouraged me because of their stories. So, yeah, the patient aligned trials will not only help with retention so it'll ensure that people stay on the trials if they're on them but it could also then help with recruitment to say, oh this is working really well for me or it's logistically easy, the reimbursement if there is some is great, or whatever it is. If we have more patients having a good experience and more patients sharing that good experience, then it will encourage more people and unfortunately, I think at the moment people may only be sharing their negative experience that's the nature of humanity.

Maya:

Right, we are vocal about the negative experiences and also about our positive experience and that's why we need to advocate, promote also the positive experiences, because there are definitely such many. Like you mentioned, the patient-aligned clinical trials can be a big benefit. That's the thing, actually, that many people don't recognize Pharma, patients and clinical research, not even speaking about only pharma. Even academia, private, governmental, clinical research and patients. We want the same things, because the better the patient experience is, the faster. Because the better the patient experience is, the faster companies and institutions will actually receive their results and data and the faster they'll know that their investment is worthy or they can allocate the investment in a different direction, or the faster they will recognize. Okay, probably I need to tweak somehow the clinical trial. So we are having the same goal, right?

Clarinda:

so this leads nicely into what I was going to ask you next, which is about patient experience in clinical trials and we've spoken quite a bit about that and I know that you've done some work around measuring patient experience. I personally had written a paper last year that got published, where I spoke to quite a few bit more about that and how you plan to use that model of understanding, capturing, qualifying and quantifying patient journeys and using that in clinical trial design thanks for mentioning that.

Maya:

As a matter of fact, we did publish a publication. It's about a methodology that we found to quantify the patient experience. But before I explain about the methodology on the high level because it's, first of all, it's very complicated, second, it's not my statistical background I want to explain actually why, why exactly we're using terms like quantification and so on and so forth. Right? So that's to do with exactly with the barrier between patients and the industry. So when patients are vocal about their needs and expectations and their experience, right, imagine when they speak, they speak with words, with descriptions, with the so-called qualitative data, right, with sentences, with stories. That very often, by the way, happens with patient-focused groups as well. So you're in a patient-focused group and you have the researchers or whoever is representing the institution or the company, and you're listening to the patient stories, what they need, what they've experienced, and so on and so forth. But somehow you need to take these stories and to transform them into insights that can help you make decisions.

Maya:

And when we make decisions as human beings, how do we make decisions?

Maya:

We usually use some sort of numbers, something that's more quantifiable, and sometimes it's very hard to take someone's story and make sense of this story to actually make the decision whether you should have two visits per week or two visits per month, right.

Maya:

By the way, that gave you probably the worst example, but let's say whether they can travel 100 miles or 20 miles. There are multiple examples like that, and that's why we saw that there is a need for finding models where you quantify qualitative data, you turn it into quantitative insights that can be easier digested by the industry so that when they make decisions, these decisions are aligned with the stories, right. So that's why we came up with that. The methodology has to do with different statistical models that are innovative in the way we're using them, but they've been used in other industries beforehand. We're using a very unique combination of these methodologies so that at the end, the result is such that you take a big amount of information in a qualitative format and eternity to see insights that can help you understand. If I have this number of visits, would that actually impact my retention recruitment rate, for example, if I have?

Maya:

that type of a distance from the site, would that actually impact my retention recruitment rate, for example, if I have that type of a distance from the site, would that impact decision making?

Maya:

Or let's say how many people, for how long they will stay in the clinical trial, if I'm to introduce infusion versus the pill, would that impact motivation and so on and so forth. Basically, and while we're doing that, one last clarification because of the status quo today. The status quo is such that first I mentioned the patient focus groups and one of the inefficiencies is exactly you take qualitative data but it's hard to make sense of this data. But the second reason is because right now the only quantitative data that you can use for making better decisions on patient journey for your new clinical trial is if you learn from past clinical trials, because in past clinical trials you see their recruitment rate, more or less, you see their design. You can kind of like connect the dots. But what happens is you kind of say I want to be better than what was in the past. But if what was in the past from one to ten was two and you make it three, that's not is that better?

Maya:

no, maybe it's better, but is it good enough? But if you learn from the existing patients and their ongoing journeys, maybe you can do it. Five, six, seven why not eight?

Clarinda:

that's great, and what state is this in at the moment? So is this still an algorithm or a model, or is it already in development as a tool? Is this usable in some way by people, or is it going to be usable in the future?

Maya:

yeah, so part of it is already usable.

Maya:

It's actually super complicated because, the model requires data, and so for years we've been fighting to collect the right amount of data and the right data in the right format, and so on and so forth, and I think that we are the state where we actually exactly managed to do that, and now we are in the process of turning that data into insights and insights into analysis. So, yes, to a big extent it's already there. We're already implementing these models into multiple, let's say, features and functionalities. I want to make sure that it's clear we do have two different products, right. One that's facing patients, the one that we provide for free for patients.

Maya:

We're not charging anyone for anything, including industry. Right, we're doing our share, saying, hey, we want to support patients. We want to make sure that more patients find out about clinical trials and, if we can connect them to the right people, we are doing that because we believe that's the right thing to do, and trial hub is actually our way to really make clinical trials more patient aligned and more successful because, like I explained, patient light is not enough. So, within this trial hub, that's where we implement these models, because we believe that if we open the eyes for the industry, for them to make better decisions. These decisions will impact then access to clinical trials, awareness and so on and so forth, and I think what's really cool about that.

Caitin:

to put it in context a little bit, bring us back to an earlier conversation we had. One of the very first things you said is about patient centric doesn't work because it's not all about the patient. It has to involve the science as well. I was just thinking about what that would mean for me. The 10 out of 10 patient centric clinical trial for me would be to take one pill and then no blood tests, no hospital visits, nothing perfect done one pill and then no blood tests, no hospital visits, nothing perfect done, and obviously that's not.

Maya:

Is it well? I don't think it is well.

Caitin:

No exactly because that wouldn't work, would it? You wouldn't get a drug or a benefit out of it. Right, it's not a helpful trial. So you have to find the balance between, I suppose, the minimum amount of data that we need, so the minimum number of blood tests, follow-ups, etc. What is the amount that can be the most patient aligning while also getting enough data to actually make the most scientific as well, right, yeah?

Caitin:

and that'll change depending on the disease, on the country, etc. And the patient perspective might also change because, let's say, I have a really debilitating disease or a disease that's going to really shorten my life. I would be more willing to risk, I suppose, increase your burden, exactly, yeah increase the burden exactly and I'll give you another perspective.

Maya:

Caitlin, you said that the ideal scenario is for you to get the drug, and actually that's it. But that's not true. Imagine you're in a clinical trial and somebody gives you a drug that may be a placebo, may not be a placebo. You actually will be super anxious, like what happens with my body. What are the signals, what are the results? So you will want to be tracked and measured. If you know that these measurements and these results are also shared with you. Sometimes you are ready to go into even more examinations if you know that this will give you a better light in the tunnel and also in what way.

Maya:

Right, these remote components of clinical trials. They can also kind of make the burden a little bit less. But burden is very subjective. That's the problem of clinical trials and patient clinical trials. But for one patient burden is one thing, for another patient burden is another thing. And we need to standardize because if you know the process of how clinical trial protocols are being done, you can't have per country protocol, let alone per patient protocol. Operations are just too complicated and you can't ensure the security, safety of this patient even and we all want to feel secure and safe, right.

Maya:

So I think that there should be a balance and also I think that here the job of the industry would be how do we make, even if the burden is higher than the standard of care? How do we make the perception of this burden to be less? Yeah, because you will be way more willing to spend more time doing examinations and blood draws if other elements are there. Let's say, there is child care if you're in, if you're a mom and have kids, for example. That if you can do the blood draws in a lab that's close to your workplace, for example. Or these lab tests are being shared with you and your, let's say, doctor, not only with investigators, for example.

Caitin:

Yeah, so there are a lot of ifs and I know it's complicated, but that's our job to figure it out and that's why it's really cool to have the kind of measurement piece that you have, because if you've just taken on a lot of qualitative insights, it's really difficult to find that balance and understand which part of the protocol would be most impactful to change or move. And also, if things aren't impactful to change or move, then maybe you just leave that part how it is. So I think it's a really valuable tool for people who are conducting the research and also it makes the trial more patient aligning and it's better for patients in the end. So, yeah, I think it's a really cool initiative that you're working on. Thank you, thank you and this.

Clarinda:

This makes me think of a conversation that we had with Bronwyn from Boringer Ingelheim on a previous episode, where she said that patient experience data is, in her opinion, something that can be shared across industry stakeholders. That's non-competitive, able to convert qualitative insights into quantitative data, for example, is a great way to be able to share that across industry. Right, because then it's not your advisory board, little bits of information or statements that you're sharing, but you're sharing a quantitative measure of something. I think that there are many applications of that.

Maya:

Yeah, actually, you're absolutely right. I hope that we'll be open for the opportunities and we'll find the compromises so that, at the end of the day, we find a scalable way to implement the patient's needs and expectations in not only clinical research in every aspect of life sciences and healthcare.

Caitin:

Okay.

Maya:

I agree.

Caitin:

So, maya, this has been such an interesting and fantastic conversation. Thank you so much for joining us today. I think we've challenged each other's thoughts and that's exactly what we wanted to do on this podcast and provide different perspectives. So thank you for sharing that with us and being super open and challenging us where we needed to be, I think. Just for the last few minutes, if you still have time, two quick questions for you. So, firstly, what would your one piece of advice be for getting clinical researchers to think more about designing better patient aligned trials?

Maya:

Well, the shortest answer is put yourself in the patient's shoes but I know that this is like super, super hard. But make sure that you actually directly speak with the patient's shoes. But I know that this is like super, super hard. But make sure that you actually directly speak with the patient and challenge your ideas and thoughts and don't work with assumptions. Just don't assume. Oh, I know what they will think, oh, I know what will happen.

Maya:

Oh, I spoke with this opinion leader and he told me or she told me this about the patient make sure that you receive direct feedback from patients and when you receive feedback from the patient, make sure that you receive direct feedback from patients and when you receive feedback from the patient, think about the practical aspects of this feedback and make sure that you go back to the patients and explain why you can implement one feedback and another one you can't. Maybe they won't understand 100% of what you're saying, but maybe 20% the next patients understand 100% of what you're saying, but maybe 20%, the next patients 30% and eventually we'll get more educated patients about what's possible and what's impossible Right.

Clarinda:

Thank you, that was a great response and, similarly, what would be your advice for patient advocates or patient organizations looking to advance patient-centric or patient-aligned clinical trial design?

Maya:

Honestly, there's so much burden on the patient advocates, and this burden comes from the fact that today, patient advocacy is more or less a voluntary work, but it's actually a full-time job, let's face it, and lots of patient advocates that I met are trying to find a way to literally make a living out of it.

Maya:

A lot of them are doing it part-time and they have another job just so that they can support their lives and dreams.

Maya:

So I'm not sure what advice to provide beyond. Just be vocal, be proactive, find your communities, be vulnerable and share your experience, and maybe the patient advocates to be united around which are these really big things that will provide impact, like, for example, if there is any way patient advocates get better enumerated so they can do more work and it's easier for them, because, again, that's a full-time job and you shouldn't be the victims of the community. You should be the heroes of the community. So really unite around the items that will have the biggest impact and be more focused, because today I have to say that it's a lot of people, like you said, one out of thousand, but even one out of thousand, maybe, speaking about different initiatives and different goals. Be more united. Educate yourself, because there are educational materials and, yes, maybe you need to be a little bit more proactive in understanding what is the industry language. Spend some time, work there, whatever, but make sure that you start understanding the industry language, because that's the only way you can make your voice understandable thanks, maya.

Caitin:

That's really great advice to end on. So thank you so much for having this chat with us today, and I believe we're going to have another chat on your podcast next time.

Clarinda:

Yeah absolutely, thank you maya I think this was a great conversation to set the tone for the year ahead and it really brought in industry and patient and multi-stakeholder perspectives. You're the first CEO that we've interviewed, so that's a fresh perspective for us as well. Thank you once again. It's been excellent having you on.

Maya:

Yeah, thank you as well. It's my pleasure and I just want to mention something we're all learning. I to mention something class, we're all learning, I'm constantly learning and we're changing our opinions, but that's the goal of having such conversations. So as my final thought be open to learn and be open to change your mind and make sure that you speak with different types of profiles of people, because that's the only way we find the way to balance. Yes, absolutely couldn't agree.

Clarinda:

Thank you so much, maya. Thank you so, caitlin. I think that was a really great conversation. I had a lot of aha moments and I was wondering about your thoughts.

Caitin:

So I think one thing for me was something that Maya mentioned right at the beginning of our conversation and that kind of changed my perspective throughout the whole conversation, and that was that she doesn't like the word patient-centric, which made me think a lot, because obviously that's a word that we use a lot ourselves and is used a lot in the industry.

Caitin:

But Maya suggested instead using patient aligning, and the reasons for that spoke to me. Actually, because patient-centric implies that only the patient is considered and while they are a really important stakeholder in this, you also need to get the science to work robustly so that the drug can pass its trial, and it needs to work for the doctors, for the scientists, for everyone. So patient aligning means that while the patient is brought in, considered, you also need to consider the other stakeholders, and I do believe that that's what patient-centric means it's bringing the patient into it. But I do understand how it can maybe sound a bit like an impossible goal if you call it patient centric. So I think that has changed the perspective and it's really important to think of all the stakeholders in clinical trials to make sure that it's collaborative, efficient, good for everyone and we get the best drugs out of it Right, totally agree.

Clarinda:

And the other thing that struck me was that there are so many obvious benefits to having patient-aligned clinical trials. If they are patient-aligned, there are clear benefits to patients in that their experience through the clinical trial is better, and that means better retention, better recruitment. So it's clearly beneficial to the industry as well. It means better return on investment, essentially and eventually, better outcomes both for patients and industry. So it seems like the most obvious way to go, and it is the way that the industry is going. But I think that we're making baby steps and there's still a long way to go in getting there.

Caitin:

The other key barrier that came out to me in terms of how do we get more people onto clinical trials is just the awareness and perceptions of the general public.

Caitin:

It seems that in every situation when a patient is diagnosed, they're not necessarily a told about clinical trials by their doctor unless their doctor is on that clinical trial team, or b they aren't thinking to look for those clinical trials because they aren't sure what it is. It seems like something that's a bit alien, a bit scary, a bit experimental. So I think we need to change those perceptions and obviously Maya's work is trying to do that, to help people find clinical research earlier. But we need to first get people to start looking for it. So that's not to put the burden on anyone, on patients or doctors specifically, but as a system. We need to raise a bit more awareness of what clinical trials are, what the benefits, and get more people to look into it. And one of the things that is impacting that is that clinical research is still very siloed, so it's in specific centres, so people outside those centres therefore aren't being told about the trials.

Clarinda:

Yeah, and I think that one thing that could definitely help that awareness is for patients who have been on clinical trials to just speak more about their experiences, like Maya said, for them to become advocates and not necessarily only speak about the good stuff, like she said, of course, just share their whole experience, because it's just such a new thing for so many people and just hearing more experiences of real people going through it I think is great for creating awareness, so we hope that we can see more of that.

Caitin:

Agree. Thanks so much for listening. This has been Not Just Patients with our guest Mayas Zlatanova and your hosts Caitlin Rich and Clarinda Suresh. Thank you.

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Caitlin Rich

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Clarinda Cerejo

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