Trials with Maya Z

Maya Zlatanova, TrialHub (00:00)
Hello everyone. This is Maya and you're with Trials with Maya Z and I'm very happy that I finally managed to bring to your, like to you, an expert that met some time ago, maybe a year ago. I speak about Todd Georgieff who actually had the privilege of meeting.

around a very important project around the European Union, but actually turned out that Todd comes to the incredible background in the pharma industry and more specifically, protocol development. Todd actually has shared with me some incredible insights and ideas around why quantifying the patient burden is so important.

and how we should be thinking about that. So when I started my series, my mini series on standard of care and the importance of understanding the local patient pathway, I thought that I should definitely speak with Todd and I can't wait to hear his opinion. So Todd, welcome and please feel free to introduce yourself.

Todd Georgieff (01:10)
Thanks, Maya, for the very kind introduction. it was a long, long time pleasure to meet you as well that we anticipated meeting one another at a couple of conferences. And I was glad that we could finally meet and start our conversation. And I look forward to continuing it with you today and beyond today as well. So my background, as you said, I've been working in drug development for many decades now. My background is mostly in

clinical operations, running clinical trials and managing groups of people who run clinical trials. I think one of the most sort of relevant components of my experience has been as a global therapeutic area lead for country clinical operations at a major pharma company where I coordinated a global team of country and regional therapeutic areas leaders as well.

And what we were doing was trying to optimize the country selection and support the performance of clinical trials that were being implemented globally, particularly in non -oncology indications, but we had peers in the oncology side as well. And as you said, currently what I'm doing is I'm working a lot in the area of protocol optimization, protocol digitalization, as well as clinical trial enrollment recruitment, particularly around

clinical trial patient matching, which perhaps we can get into. mean, what's interesting about clinical trial patient matching is that it's largely based on the eligibility criteria, sort of comparing the eligibility criteria in a clinical trial to patient characteristics. However, that really doesn't tell the whole story. And really what we're going to focus on today is the rest of the story, what makes a trial

you know, attractive or doable, either at a global level, at a country level, or at a patient or a site level as

Maya Zlatanova, TrialHub (03:12)
Interesting. So why don't we start with the beginning of the story and then we dive into the rest of the story. So what's the beginning of the story of like more precise patient recruitment? I wouldn't say precise, but more successful patient recruitment. What are these ingredients? Because like I want to emphasize on your background, you've planned a lot of clinical trials on a global level. You've seen a lot of clinical trials that didn't work. So let's say

that these 90 % of clinical trials fail, you actually experience some of these clinical trials actually like failing. So what are these ingredients that you think should be there for a clinical trial to be successful? What are the ingredients of failing clinical trials? And where does the story begin?

Todd Georgieff (03:56)
Yeah, so where the story begins, and it's actually an interesting way to think about sort of the standard of care challenge as well, because I'm thinking about this on sort of a macro level as well. I'm not exactly thinking about how is this particular indication treated within the healthcare system where I'm putting the clinical trial. Now I'm going to think one step before that, which when we are...

planning a clinical trial and trying to decide what the global footprint of that clinical trial is going to be, one of the first questions we ask is, in any given country, where are those patients? Do we know where the patients are located? How do they flow through the system? Of course, this does become sort of the meta level of standard of care. So, you know, are they seen in general practice? Are they seen by specialists? Where are the specialists? Is it a very centralized thing

oncology in most countries is very centralized going to referral centers and those kinds of things. Whereas internal medicine indications, even some more serious internal medicine complications may be treated by community physicians, community specialists as well. So the first question about that sort of meta level of the standard of care is identifying the patient flows. And then how do we place the study

so that we can meet those patients where they're likely to flow in a given geographic region? So that's the first question. And sometimes that can be, or quite often, that determines whether or not a particular country or region is suitable for a clinical trial. And it also may determine whether you anticipate a high proportion of the patients coming from that country.

Whereas the country always going to have a challenge because those patients are either difficult to locate or we just don't happen to have investigators that are located where the patients are going to flow in that particular disease area or indication. So that's the first question. And then the second question is sort of the more granular level of that standard of care question as well. Like how are those patients treated in your country?

Or in that particular geographic region, are they treated, you know, the same way it are they treated in Eastern Europe the same way as they're treated in North America? Because when we say standard of care, it's a very Generalized term, but the standard of care is rarely the same Even within the same region because there are so many different points in the evolution on how a particular disease approach

becomes a standard of care. First, the product needs to be approved, tried and approved in that indication. Then the product needs to be available in that geographic location. And then finally, it needs to be reimbursed and paid for by whatever healthcare system that patient is being cared for in. And when I say whatever healthcare system, I mean, is it some kind of national health insurance coverage? Is

regional health insurance coverage on based in Canada. Here we have provincial health plans as well, or is it according to what's approved and available in that particular hospital or clinic formulary as well. So you've got all those different layers that an individual product or treatment regimen has to navigate its way through in order for it to be considered.

standard of care where that patient is going to be seen. What that also implies is that even within a particular geographic region, you could have three or four different standards of care or more going on at any given time. So it's, know, a spade is not a spade is not a spade. It may actually vary a little bit depending on where exactly you're placing your clinical trial. How can, you know, which patients

standard of care is going to be relevant for those patients at this time

Maya Zlatanova, TrialHub (08:17)
wonder if this is so important for the planning, like even country selection. I I interviewed many different experts Todd and I've been asking them, actually, I would like to get your thoughts as well. Like how does the industry today understand the country's specific standard of care? I want to understand first that and then I'll ask you another question.

Todd Georgieff (08:41)
So quite often we rely on sort of expert advisory boards, for example. So for example, even smaller biotech companies may have a formal or an informal network of advisors of specialists, medical specialists in that disease area that they're developing the drug in, who they can reach out to and ask the questions of to be able to say,

When we say that this is the standard of care, are you confident that this is the standard of care everywhere? So the first approach is to tap into those experts. I would say on the other end of the spectrum, the large pharma company that I was working with at the time, Roche and Genentech, we were really privileged because we had the country and regional therapeutic area leaders.

Maya Zlatanova, TrialHub (09:13)
Mmm.

Todd Georgieff (09:34)
who if they didn't know, they would go and ask their very, very local experts to say, you know, where are these patients treated? While I talked about a little bit about sort of the institutional piece and the regional piece in terms of within a country, how the standard of care could even vary in many countries, whether we're talking about Latin America or Eastern Europe, or even in Western Europe or North America, there's also sort

different tiers in the healthcare system where, yes, you can find those patients who are being treated with those standard of care, but they're only on the private side or they're only on the public side and you're not going to find that standard of care on the other side. terms of how it really comes down to sort of tapping into the local expertise, sort of database driven tools like the TrialHub tool would be super valuable as well.

Maya Zlatanova, TrialHub (10:19)
interesting.

Todd Georgieff (10:34)
I kind of wish we had those as a starting point to be able to ask at least to ask better questions, even in a situation where we had those local experts to be able to have a more validated starting point, I guess, when you start to design the clinical trial and start to anticipate where the best place is going to be to place the trial.

Maya Zlatanova, TrialHub (10:54)
But like you mentioned that now you're advising different protocol optimization approaches, even platforms. If the local standard of care has such an impact on the, let's say the protocols performance, are these platforms and software approaches basically considered this local standard of care, especially if this is taken from an expertise and conversations with people? mean, is that even possible?

because usually we envision softwares as these country prioritization tools and eligibility mixer and stuff like that. So are they even able to take into consideration qualitative insights gathered through calls and emails?

Todd Georgieff (11:42)
I'm going to optimistically say yes. And that can show up in a couple of ways. One, it could show up by maybe even informing the design to be able to say, we design it this way, it's going to be very difficult or impossible. If we design it that way, just change the trial requirements for design just slightly, we may enable the trial to be more successful. So that's sort of one layer. The other layer is really to be able

moderate or set your expectations to be able to go at least to go in with an informed view of what the challenges are going to look like to be able to say okay if you're going to require that standard of care or if your protocol design and your patient flow assumes this kind of standard of care then you're probably only going to be able to recruit patients half as fast as you would if you changed a few things if you changed your expectations as

The other thing that we haven't mentioned is that in some cases, and we've made sort of casual reference to the different payer scenarios that can happen in a particular geographic location. In some cases, this is certainly an opportunity as well, because perhaps patients in that particular geographic locations have, location have challenges in having access to those standard of care treatments.

Whereas if I am planning a clinical trial and I'm going to place a clinical trial in that region, maybe I just plan to provide the standard of care or pay for the standard of care as part of my study budget that I need to make sure that I'm budgeting to be able to either provide it as investigational medicinal product, as I have to do in some countries, it all needs to be packaged and labeled like trial supply. Or in other cases, I'm just sort of inviting that

healthcare system or provider to invoice me for the standard of care so that that becomes an opportunity and an attractor for for sites in countries and regions to participate in the clinical trial. There are a couple of different sort of ethical questions, but around that, of course, around sort of coercion. I think there's there's two sort of main ethical implications for that. One one is if

Maya Zlatanova, TrialHub (13:56)
Of course. Yeah.

Todd Georgieff (14:06)
Luring the patient to participate in a trial because they can have access to a standard of care that they wouldn't have had access to otherwise, is that okay? That's a bit of an ethical conundrum that we need to work through and ask ourselves the question. And the other sort of major ethical question that that raises for me is what happens after the clinical trial? So if you're providing a chronic long -term therapy that's maybe disease modifying or keeps a patient stable,

Maya Zlatanova, TrialHub (14:28)
Yeah, of course.

Todd Georgieff (14:35)
and the patient completes the clinical trial, what arrangements have been made or can be made to make sure that the patient is not dropped from their treatment at the end of the trial? And of course, there are international expectations here. You can't do that. You have to plan accordingly.

Maya Zlatanova, TrialHub (14:49)
Yeah. And I think I'm not sure it was you or someone else that I've been discussing that. Thanks for bringing this up because indeed, understanding the local standard of care is not only for the planning of the clinical trial selecting the country with the most eligible patients and the most motivated patients, but also to understand what are you supposed to be doing after that. So in the case that this treatment is not provided in the country, like you said,

Todd Georgieff (15:11)
Yes.

Maya Zlatanova, TrialHub (15:16)
Indeed, you can find more motivated patients to join your clinical trial. At the same time, the question is what happens after the clinical trial. And I've been having this discussion because I was like, it's super natural. Like you should provide access to this treatment. And for many pharmaceutical companies, actually that's a great opportunity. If that has been working, they can continue generating real world data on how, on the let's say long -term effect of this treatment.

And at the same time, you provide the treatment to these patients. So it's kind of a win -win situation. But then, I'm not sure it was you, maybe someone else, told me, yes, but actually providing this treatment after the clinical trial is finished is way more complicated than you even think. Because sometimes this treatment may require additional procedures that are not being supported by the, let's say, the local authorities. Imagine like this treatment, for example.

Todd Georgieff (15:43)
Thank

It's very complicated.

Maya Zlatanova, TrialHub (16:10)
requires this procedure and it say this is not covered by the local health insurance, for example. So who is going to pay for that? The hospital well no the hospital wouldn't have the budget for that. So that means that the patients have to like to do that. But is that ethical if they can't? So it's a long story. I agree. I definitely agree. But it's something we need to start speaking about because

Todd Georgieff (16:31)
so many layers.

Maya Zlatanova, TrialHub (16:35)
It is important. There are many other topics like that. But let me bring you back to the protocol optimization. And you mentioned that back in the days, but even now you're trying to advise and consult companies how they should be optimizing their country selection around the standard of care. I wonder, can you mention which are some of the biggest implications if you don't do that? What will happen if you actually select the countries, you go there?

You haven't researched the standard of care. What will happen in such scenario or what may happen?

Todd Georgieff (17:11)
To simplify it, it just means that the recruitment rate could be vanishingly lower. The study may not be doable in the country. So for example, if you're saying, this is a phase three clinical trial and we're gonna compare patients who are on stable background therapy and one arm is gonna have my new treatment, my new intervention and one arm is gonna have no intervention or a placebo, for example.

background therapy plus or background therapy versus placebo plus placebo, right? Those are the two, the two treatment arms. Well, in some ways you're saying, well, if, you've picked the wrong background therapy, standard of care, background therapy, then you, those, those patients as described literally don't exist, right? In your country, that's great. You want patients who have that background therapy,

We don't have those patients in my country. So the way this gets handled in a couple of ways, that can be handled in a couple of ways. One is you may permit like a pre -treatment onboarding phase where, for example, we may say, actually, the patient should be on that standard of care background therapy maybe for three months or six months before they enter the trial. Well,

fine if that's the way the study is going to be designed that's probably totally fine but now you have to acquire a supply of that background therapy or help the country acquire a supply get it to the centers make it available to those patients onboard them so you've really talked about more delays so I mean the short answer to your question is what what happens is delays you either delay because the patients don't exist and they're not going to come

and it becomes an expectation that the other countries are going to pick up the slack, or there's a delay because you have to onboard the patients to that background therapy, give them time to get stabilized on treatment. Okay, now they're ready. Now the patient, we've created the patient who can now participate in the clinical trial as well.

Maya Zlatanova, TrialHub (19:29)
interesting. What about the second part of the story? how to make the clinical trials more attractive to patients? You mentioned that the first part is this overall assessment and understanding how to position your protocol best for success. But then the second part of the story is how to analyze the standard of care to actually see how you can make the clinical trial more attractive to patients. And I guess also to investigators.

Todd Georgieff (19:56)
Yeah, I think you and I talked about this in one of our first conversations as well. And I'm going to connect this back to the question of patient burden. When you think about how to think about patient burden in a clinical trial, one of my sort of ongoing concerns or complaints about the way we normally talk about patient burden is that the drivers either have to do with, you know, how much time does each patient visit take? How much data are we collecting?

Maya Zlatanova, TrialHub (20:06)
Mm

Todd Georgieff (20:26)
how many procedures are we doing, which are all important. However, they're not a complete measure of the patient burden either, because the number of procedures is different if those procedures are done by four or five different hospital departments than if they're all done by the actual investigator clinic. The patient is not having to move around or we're not having to coordinate different assessors and different types of procedures.

appointments with imaging, know, invasive surgeries. So that's one thing, like what's the number of handovers that are in the thing? The other piece that are there in the schedule assessments, the other piece is like invasiveness and pain and discomfort as well. You know, so a patient that has to have an invasive painful procedure is going to experience more of a burden and more discomfort and, you know, the protocol is probably going to be less acceptable.

Maya Zlatanova, TrialHub (21:04)
Mmm.

Todd Georgieff (21:25)
or more difficult to recruit than a study that doesn't have those kinds of invasive procedures. So that's easy enough, sounds obvious. But the other thing that I think sponsors need to do a better job considering is compared to what? So when you say a protocol is very burdensome or invasive or difficult to do, well, that's really

it's really relevant to consider compared to other protocols that are happening around now in that therapeutic area. For sure. That's probably the first question that comes to mind. Is my protocol the most burdensome amongst the protocols that are recruiting patients now? Or is it among the least? Where does it fall? The other piece to come back to the standard of care question is, you know,

patient or an investigator's tolerance for standard of care is going to be much different in a very intensive treatment area. I'll pick my favorite example, something like liver transplant. If a patient is going through a liver transplant procedure or renal transplant procedure, they're already going to be sort of in the system, in multidisciplinary care. Those treatment settings are going to be very used to sort of handovers and coordinating care amongst different specialists

Very different if I'm doing like an internal medicine trial in diabetes, type 2 diabetes patients for example, where yes, maybe there's ophthalmologists and neurologists and things like that around there, but some of the more invasive or painful procedures, they're a little more foreign, they're not part of the normal routine. So really having a sophisticated view of not only the standard of care like

what drugs and what treatments need to be administered, but also understanding how different the trial schedule of assessments looks from sort of the normal care of those patients in that clinical setting, in that indication.

Maya Zlatanova, TrialHub (23:37)
What you're saying is something that I've heard from a patient advocate lately. I published the episode with Carol and it's super insightful to see that how do patients actually decide to join a clinical trial. And they're not comparing to other clinical trials most of the time. mean, when we compare actually the patient burden, we usually do

exactly by comparing different clinical trials that are out there to similar indications and thinking, is my clinical trial better than the other ones? But in reality, the patients would compare their existing healthcare system and their existing daily routine around their disease compared to what it would be like if you are a part of a clinical trial. And not only the visits are part of the clinical visits, procedures are part of the clinical trial, but everything, their daily routine once again.

Only when you feel that the value proposition, the clinical trial, let's say your motivation exceeds the additional commitment that you have to give to this clinical trial, only in this case, you would actually go and participate in the clinical trial. Only when you feel secure that actually you have a lot more attention, you have really a chance for something better. And for different diseases, you're absolutely right. Like this motivation varies a lot, but it's

comparing between different clinical trials and their numbers of visits and procedures. It's actually like this clinical trial compared to what you're already used to and how much more uncomfortable you're gonna be. Actually you're thinking, how much more am I gaining out of this? Health benefits, care benefits and so on and so forth. And one last thing I wanted to mention, that was eye -opening at least to me. It's not only the procedures and the visits, but basically,

you also, your trust level in the clinical trial also comes from the trust level in the healthcare system. So these are, like the patients I'm interviewing, they're saying exactly that. If I received care, attention and all the information I needed from the existing, let's say medical team that I work with and that are now suggesting me a clinical trial, the likelihood of me trusting this medical team is much higher compared

Todd Georgieff (25:36)
Absolutely.

Maya Zlatanova, TrialHub (25:57)
a medical team that didn't actually care that much. And in the case of Carol, she went for the clinical trial because for the first time she saw that her doctor is looking at multidisciplinary approach because she has multiple indications and on top of that cancer, the clinical trial is for her cancer basically. also the trust in the healthcare system plays a role when they're making decisions. Actually, how do we quantify the patient burden to date?

I know you're researching the space, so what is the usual way of quantifying the patient burden? How often do we do that in the industry and how do we do that today?

Todd Georgieff (26:36)
There's a number of different models that are out there now. There's a number that are kind of proprietary that different protocol designer tools have, for example. Some are using a surrogate for the length of time that an assessment takes, for example. So there's something called an RSU, and I'm trying to remember what they're, or RVU, relative value units that

US Medicare centers for Medicare use or calculate. And they've been used as the basis for reimbursement calculations. So for example, Medicare pays more for a procedure that takes an hour than they pay for a 15 minute procedure. So those RVUs, the relative value units are used as kind of the basis for the assessment duration. And then what I do is I basically like

look at all of the different assessments that are in the schedule of assessments on that visit and I sum them up. So I say, this is going to be a three hour visit. The next one's going to be a one hour visit. So that at least that gives visibility. And that is definitely if you are considering, if you're a patient who's considering the clinical trial or a caregiver who's considering the clinical trial, it's very important to know are your clinic visits going to

Holding on or are going to be something you can do you know in an hour before you go to the office before you go to? Before you go to work

Maya Zlatanova, TrialHub (28:09)
Yeah, makes sense. like, sorry to interrupt you, but isn't that only US focused? Because like you, for example, you're in Canada, like how would they know what would be the burden for someone from Canada, for example, or what about the rest of the world? like you said that you've been planning global clinical trials. So how feasible is this quantification method for global clinical trials at the end of the

Todd Georgieff (28:37)
I think they're relatively valid, but it's kind of a blunt measure, right? It's not a very precise measure. And all I'm doing is I'm taking, and many years ago, I was doing a trial with a biologic and a dermatology indication where patients were used to getting prescribed like a topical treatment for their psoriasis, and then they'd go home and apply it. This was a biologic where they had to,

sit in the clinic for an hour and a half. They had to do all kinds of quality of life questionnaires, those kinds of things as well. So we went from a one hour visit to a six hour visit or an eight hour visit in the clinic as well. At the time, what I did was I sat down with the schedule of assessments and an Excel spreadsheet and I did it kind of manually, sort of educated guessing and speaking to

Maya Zlatanova, TrialHub (29:30)
Mm

Todd Georgieff (29:35)
the clinicians at the time and saying, okay, I'm thinking this is going to take five minutes, this one's going to take 20 minutes, and then really just summing it up roughly. So at the end of the day, that's still going to be, it's not going to change very much from one country or region to the next, that sort of blunt measure of estimate, I guess I'll say, blunt estimate of how much time it's going to take. What may change is how

Similar or different is this from what was going to happen anyways, right? Like that may be different. So, you know, perhaps that I'll stick to my dermatology example, perhaps that sort of dermatology clinic is embedded in internal medicine in one country and in another country, it's really only going to be like a private dermatologist sitting in his, in his, you know, one practitioner office. So he's going to have to

really need to rally more resources than what would normally be there as part of the normal treatment of those patients in that particular region as well. So the time measurements are probably relatively consistent, or I'll say consistent enough across different regions. The other thing to think about is sort of, and I've mentioned this or hinted at this a couple of times is

Maya Zlatanova, TrialHub (30:45)
Okay.

Okay.

Todd Georgieff (31:04)
How many handovers are going to happen? So, you know, if a patient is going through a study visit and everybody's going to come to the patient, so the patient basically has to walk up and down the hallway in a particular clinic, that's probably a little bit burdensome, but it's less burdensome than if the patient needs to be, you know, brought in the hospital, across the hospital to an imaging appointment.

or from the imaging appointment, and now they need to go to a laboratory to have a sample collected, or they need to go to an operating room to have a biopsy taken, or those kinds of things as well. Every time that there is a sort of a department change for the patient, that adds a tremendous amount of burden, both to the site and to the patient, because it implies, you know, gotta wait for the transport, gotta wait for

for that next procedure to begin and to end. And now I need to wait for the transport to bring me back to the main investigator site as well. those are the kinds of things where it takes a little bit more insight into how will the site be organized as well. And of course, we really haven't even spoken about, you know, the options for decentralization and bringing some of those procedures closer to the patient, whether

Maya Zlatanova, TrialHub (32:09)
Mmm.

Interesting.

Todd Georgieff (32:32)
procedures that can be done in the home or via telemedicine or remotely fully, or whether it's something that can be done, maybe it's a sample that can be collected in the clinic down the road, as opposed to making you go to the teaching hospital that's in the city center. So those are other ways of sort of thinking about that, the elements that drive patient burden and options that you can do to try to diminish some of the burdensome,

burdensome aspects of clinical trials as

Maya Zlatanova, TrialHub (33:04)
Yeah, well, definitely the centralization is one method for making the patient burden less. And I want to add to what you said, Todd, it's not only the waiting time, because if you're a healthy person, you may be, I can wait 15 minutes, or I can go to the next hospital. But here we speak about people with going through a treatment, going through sometimes very serious diseases, people that also have to be with their caregivers.

So it's not only their time, but the caregiver's time. So yeah, I can see why this is so important. I wonder, because we don't have much time left, but I want to make sure that I also get your expertise from so many years. If you have to compare what it was like to plan a clinical trial back in the days when like you were just starting your career, or let's say you were on the top of your career planning these global clinical trials.

selecting the right countries and so on and so forth. And compared to now that you're even consulting companies on building platforms and so on and so forth, have we changed the way we clinical trials tremendously? And where does this change come from? Is it the technology that we have available? Is it the data that we have available? Did we manage to change anything?

Todd Georgieff (34:29)
I think so. It's definitely still a work in progress, but there's a number of different technologies and tools that are available. I think companies are beginning to do a lot of experiments where they're really benefiting from the ability to access historical or external data, to be able to do things like modeling and to learn from historical clinical trials as well. And I think we're doing a much better job of asking the right questions than we were.

So certainly the adoption of new technologies, new tools, including some study designer tools, for example, and I make reference to this in one of the articles that I wrote around navigating towards a digital protocol and applied clinical trials. There are study designer tools that have like metrics and analytics embedded right in the user interface. So as I'm designing

a visit schedule or a schedule of assessments, I can see in real time how are these things adding up, both in terms of time or in terms of cost or even things like blood volume or tissue sampling, those kinds of things as well. you know, I can have as a clinical scientist who's designing the protocol, I can actually have data that helps me see the implications of some of the decisions I might be making before it's too

before I, you know, in the old days and sometimes still we have a habit of, you know, the clinical scientist designs the protocol, hands it over to the clinical operations person like me, and says, here, this is it. This is the way it has to be. And the clinical operations person goes, I don't think this is, this is going to be hard. This is going be very hard for all of the sites to do around the world.

Maya Zlatanova, TrialHub (36:01)
think.

Todd Georgieff (36:25)
Whereas had the clinical scientists seen the data, seen the fact that, I I'm making it up and it happens, know, visit two is actually like nine hours long. Who can do a nine hour study visit because of that patient and their caregiver and the transportation and the invasive procedures and all those other things. You know, had you known that the clinical scientists probably would not have designed the study visit like that on purpose, but they didn't have the data until later, right? So, so I

Maya Zlatanova, TrialHub (36:51)
interesting.

Yeah, interesting.

Todd Georgieff (36:55)
How it's changed, the technology is in place. We have much more history. We have many more scars and bruises. We were able to learn more from each other and from our past as well. And the expertise that we can get from our implementation partners, like the global CROs as well, have a lot of this expertise that they are anxious to bring to the table in particular therapeutic areas to help.

to help sponsors to be more successful from the start.

Maya Zlatanova, TrialHub (37:28)
Thanks for that. I have one last question. What would be the main thing that will, let's say, be the next game changer for even more efficient clinical trials? If, let's say, what's changed from before now is the availability of data, availability of more know -how, we've tried different things, we've felt, and now we learn. If we were to have the same, let's say, conversation five years from now, what would be the thing

you will name the game changer thing that brought us to even more efficient clinical trials. Can you predict that one? Maybe two?

Todd Georgieff (38:05)
I think, and this might be a bit of a sideways surprise, what I'm gonna say is data interoperability is gonna change a lot. So what we're seeing now is more and more talk about sort of data standards. A lot of the talk in the industry is centered around CDISC, the Clinical Data Interchange Standards Consortium. And CDISC

increasingly working with other standard setting organizations like HL7 FHIR as well. And what we're seeing is the ability for different types of data, different data streams to all sort of come together in a way where I can sort of compute across different data domains as well. So let me just back up one step, because if I'm talking about sort

clinical measurements that are done using an electronic data capture system. And the investigator is sort of signing, logging onto the EDC and entering the measurements, transcribing the measurements into a data collection form on his computer. That's different from what if I have a digital end point that the patient is collecting through a wearable device that they're wearing home? What if I have like an imaging report that's being done by a central imaging lab or

central reader and I'm going to, you know, upload those data reports in bulk, the imaging endpoints in bulk, you know, periodically or even on a daily basis through the study. Somehow I need to be able to bring all of that information together so that it's available for analysis and to draw conclusions about how the study went. And to me it seems like through, thanks to projects

Transcelerate's digital data flow initiative that I've been involved with for a little more than five years now, thanks to the work that CDISC is doing, both with the CDISC data standards, as well as with things like the Vulkan Accelerator with HL7 FHIR And there's a couple of other things that are going on in the industry right now. I feel like the ability to be able to compile and analyze and have access to all of that data.

is going to be sort of the game changer for us, for the industry. And I think within the next five years is a reasonable timeline to see real shifts beginning

Maya Zlatanova, TrialHub (40:35)
Interesting. So what that leaves us with is hope and an interesting future that I guess we need to discuss once again five years from now, Todd, to see if we were right. But let's cross fingers. I'll definitely make sure to add some of the links to these projects that you mentioned as part of this episode. Thank you so much for the insightful conversation, for sharing your thoughts and perspectives.

I'm very happy to hear this hopeful, yeah, these hopeful thoughts that things have changed, but will be even further changing for better because we need that in order to make clinical trials more effective.

Todd Georgieff (41:19)
Thanks Maya. It's a really exciting time to be working in our industry because a lot of these problems that we've been struggling with working our way through for the past 20, 30 years, it feels like we're kind of at a bit of a tipping point where a lot of the pieces are finally falling into place and now we just need to do it.

Maya Zlatanova, TrialHub (41:22)
Indeed.

at the

Well, that's the reason I started this podcast alone because I wanted to bring all these awesome initiatives, perspectives together because I agree with you, Todd. I think it's about time to do something, like to change something about how effective the clinical research industry is. We all want that. We all need that. But it's also a great intersection of both technology progress and interoperability.

and also passion and motivation and know -how, the scars that you mentioned. So now it's a good timing to achieve that. Thank you once again for your participation.

Todd Georgieff (42:17)
Thanks for the opportunity. Thanks, Maya.