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2023 Trends

April 24, 2023

00;00;03;26 –> 00;00;17;25

Hi everyone and welcome back to the Advarra in Conversations With Podcast. I’m Bryan Spielman, the Chief Growth Officer at Advarra. I’m thrilled to explore clinical research industry predictions and trends for 2023 today with Advarra CEO Gadi Saarony.

00;00;17;25 –> 00;00;29;27

Hi everyone and hi, Bryan! I’m just fascinated by this microphone that I have in front of me, so I think I’ve made it. I’ve made it in life. Now Im on a podcast with the real professional microphone.

00;00;29;27 –> 00;00;36;28

Well, we can talk about that, or we can talk about the clinical research space. What do you prefer?

00;00;36;28 –> 00;00;43;00

Well, I suspect I know a little more in the clinical resource space, but we’ll find that out momentarily, wont we?

00;00;43;00 –> 00;01;14;13

That sounds good, all right. So, let’s get started. Maybe we’ll start with a high-level question. There’s been a lot of discussion about how Covid had has really changed the life sciences industry especially related to the way clinical research is run. I think some of those changes will stick and some of those changes won’t. And so maybe we can start with that question. Which changes do you think are going to stick, and which changes do you think will fall away? And what have you seen so far since you know we’re sort of at the tail end of the pandemic.

00;01;14;13 –> 00;01;48;04

You know, I think, Bryan, its to be seen. I would even take a step back a little bit and say what was really different right? And I think the biggest difference is the daring, the open mindedness, the willingness to just try new things and experiment. I always said that I, you and I talk about it often that when you look at R&D, the R runs much faster than the D. So, the science is progressing really fast, but frankly, development hasn’t changed all that much and I think, during Covid in particular, there was this open mindedness, this, this willingness to try new things to experiment

00;01;48;04 –> 00;02;17;01

To throw out the old processes and see what sticks. And so I think that that was a big mind shift more than anything else. Now, of course. Look, let’s also acknowledge that the circumstances of Covid and development of the vaccines were very unique, and maybe something we see once in our lifetime, but the ability of Pharma in particular, and in partnership with CROs and in partnerships, with IRB, for example, with us at Advarra, the willingness to

00;02;17;01 –> 00;03;05;27

really try new processes, the willingness to implement technologies in a much faster way, the willingness to look at the design, at the protocol design from the perspective of not just does it give us the ability to that, as I would say, you put a set of therapeutic area heads and bio statisticians together, and to design a protocol that really tries to explore the optimal endpoints. This was an instance where it was very clear what needed to get done, and the trial designs were done in such a way that really about how do we solve for this one problem? And how do we get the patients in as fast as possible, or the subjects in as fast as possible, and do whatever it takes to enable them to participate in the trial; and I think that was kind of a big shift from the typical way of doing things.

00;03;05;27 –> 00;03;33;22

And you know, along those lines there’s a lot of discussion about increasing trial complexity, you know, and that’s always, that seems to be a constant comment around clinical research that it keeps getting more and more complex, You know, challenging life sciences, companies, challenging sites, challenging patients. Do you see that as an impediment, a continued impediment? Or do you think there’s a path to simplify clinical research?

00;03;33;22 –> 00;04;05;28

Yeah, sure, you know it’s funny, because what complexity often comes from, is an outcome or an output of trying to actually simplify things. I’ll give you a great example. I actually just had a conversation, a phone call with a sponsor this morning, and one of the things that we highlighted was that Look, clearly complexity is coming from different therapeutics that are coming to market or coming into development, which are by definition more complex. We look at cell therapy, gene therapy, look at some of the personalized medicine, the immunotherapies.

00;04;05;28 –> 00;04;36;21

Those things, by definition, are more complex. Those things by definition, are new, and therefore haven’t been tried before so there’s less, there’s less experience, less data sets to tell you how to do things right. So with it comes complexity. But the other point of complexity actually comes from the effort of the sponsor to design a protocol that’s easier for a participant to take a part in. So, for example, when you’re starting to think about, how do we make sure that a participant gets access to a trial,

00;04;36;21 –> 00;04;51;15

you start thinking about: Well, can we do some things in the remote modality? Can we collect data using a wearable? Can we actually go to far corners and find patients that otherwise wouldn’t know about a trial.

00;04;51;15 –> 00;05;59;23

All that, by definition adds complexity to the process itself. So it might make it simpler for the patient, for the subject to participate, but actually makes it much more complex for the site to conduct the clinical trial. So there is a set of complexity that comes with the effort to actually make it simpler for patients to participate. There’s a set of complexity that comes from the nature of the therapeutics that are coming to market the nature of the science. But I will also say, there is a complexity that’s coming about as a result of innovation in how we’re trying to conduct clinical trials. And what do I mean by that? There are so many companies right now who are offering some sort of technology or another to sponsors and to sites. Now, all of a sudden, the sponsor, the site, the CRA, the monitor, has to deal with many more inputs, with many more technologies, with many more processes that creates complexity, so that innovation, that effort to actually try to digitize clinical trials much more by definition, creates complexity. I believe that over time

00;05;59;23 –> 00;06;20;08

that will become simpler, and I think it will become simpler because you’re going to have better data standards. You’re going to ultimately have fewer technologies, and we’re going to call less around those technologies that work, and those that don’t work are going to fall by the wayside. I think that’s going to create some sort of simplification, or at least an easier burden.

00;06;20;08 –> 00;06;38;21

And ultimately, I also think, as we learn more about these new therapeutics, we can adapt the protocols much better, and that, too, will drive some less complexity, more simplicity. But look any which way you look at it. Clinical trials are complex and will always stay complex.

00;06;38;21 –> 00;07;03;15

You know, I think that the point around protocol versus technology and which is really driving, and they’re interrelated to some extent. But if you are going to try to weigh the impact of the protocol complexity versus this constellation of different technologies which one, do you think has more impact on the functioning of clinical research?

00;07;03;15 –> 00;07;13;28

Yeah. I’m sure there’s a scientific study that can be done on that.  I haven’t done that study. But I will tell you this, If you look at the

00;07;13;28 –> 00;07;42;14

scientists who designed the protocols, they get it, they get the complexity of it, and they get ways by which to simplify. If you look at the investigators who are conducting the trials, they know how to conduct complex trials on complex protocols. They understand the science. And yeah, some requires a little more training and education, few more procedures. But for the most part the investigators get exactly what they need to do.

00;07;42;14 –> 00;08;06;12

I think what is really complexifying to the extent that’s the word. What’s really complexifying the trial is that now that investigator has to deal with more and more technologies more and more requirements for going decentralized in some areas more centralized in other areas

00;08;06;12 –> 00;08;18;05

Like another example, I spoke to a site that told me that they are working with 18 different recruiting firms to help them recruit to a trial. Now, this is across multiple trials, but that is complex.

00;08;18;05 –> 00;08;40;28

And not only is it complex, it’s actually also discouraging to the investigators who really want to see patients. They want to do the research, and ultimately what they’re doing is they’re spending much more time managing vendors, entering data into multiple technologies. So if I had to sort of put the weight on that. I think protocols have definitely gotten more complex

for the reasons we’ve mentioned.

00;08;40;28 –> 00;08;54;23

But the investigators know how to deal with that complexity. I think the complexity of the proceed of the processes, the technologies. I think that’s something that is probably disproportionately delaying clinical trials.

00;08;54;23 –> 00;09;19;02

Thats very helpful, and a good segue into a conversation on site-Centricity, which we think is

another key trend for 2023, and you know, has been important, but maybe increasingly important for the factors that that you just walked through. So, I guess maybe one question is, why is site centricity becoming increasingly important? And I’d like to tie that to the to some thoughts around the future of

00;09;19;02  –> 00;09;38;12

of clinical research at academic medical centers, and it at hospital systems, because again, as we saw over the last few years. there have been challenges around recruiting people to work at these sites, not only recruiting patients, but actually making sure the sites are fully staffed. So, maybe

00;09;38;12 –> 00;09;57;11

again, this sort of broader question around, Why is it interesting, important? And then maybe a more micro question about is this  a long term and important business, because it is a business right that that these hospitals and health systems and academic medical centers and others will continue to invest in.

00;09;57;11  –> 00;10;01;07

Yeah let’s start with the first question first, I mean the second one is.

00;10;01;07 –> 00;10;44;21

It’s more micro but it’s actually a macroeconomic question. I will say this: that when you think about site centricity, everybody talks about patient centricity, and in the effort to actually get to patient centricity there been a set of modalities, a set of innovations, a set of experiments to try to figure out how to better enroll a patient, make sure that they stay on trial. And by definition the thought was, Well, why not do more things from the home? Why not do things in a more decentralized fashion? And do you really need to be so dependent on the sites, and my answer to that is.

00;10;44;21 –> 00;11;12;21

if you want patient centricity, you better have site centricity, and the reason is the following: there is actually a number of reasons. And this is from a personal perspective which, by the way, I I’ve had the really personal experience with my dad, who very recently had an aneurysm, and I will tell you some of the procedures, and he joined a clinical trial by the way, ultimately had to drop out that clinical trial because the procedure that was being that was being experimented with it wasn’t appropriate for ultimately what he had.

00;11;12;21 –> 00;11;14;27

But he is okay, and he is at home. So

00;11;14;27 –> 00;11;16;19

he’s okay, and he’s at home.

00;11;16;19 –> 00;11;30;21

Much to, I’ll tell you the happiest of all clearly my mom, but no one is happier than his dog right, because he just wasn’t getting as many freakin walks when he was away at the hospital. But I will tell you that

00;11;30;21 –> 00;12;09;17

when you think about what he when I was thinking about what he was going through, there are certain procedures that I would just never do at home, and he would never do at home, and frankly, no physician would ever recommend to have done at home. So, no matter what you are going to need to site. The second piece to it is that I look at it and look, we’re conflating a few issues here together, but another piece around the whole patient’s centricity and around how do we really improve clinical trials was around diversity and inclusion in clinical trials? Right? The reality is, there is a population that has 0 desire in

00;12;09;17  –> 00;12;20;04

the nurse coming to their home. So if you really want to have diversity and inclusion, if you really want to have patient accessibility, if you really want to have patient participation.

00;12;20;04  –> 00;12;41;02

the investigator is critical to clinical trials. The site in which that investigator is working in is critically important to clinical trials. So to me, site centricity is really all about patient centricity. This is not to say that you can do somethings remotely, of course you can, and I believe decentralized really means hybrid. But I also believe that

00;12;41;02 –> 00;12;51;23

the site needs to evolve the site needs to think more broadly by that. What do I mean? Not everything needs to be done at the central site.

00;12;51;23  –> 00;13;00;26

You can do certain procedures much closer to home. I don’t need to travel 30 miles to get to that hospital where the where the PI is at.

00;13;00;26  –> 00;13;19;25

There are certain procedures that I can travel 5 miles down the road and do them there right? But even that requires a site. It’s a different type, but type of site. But it’s a site, and the more procedures you have. And, by the way, we are seeing a significantly increase in number of procedures per trial for protocol. Right? The more procedures you have.

00;13;19;25  –> 00;13;30;09

It’s not likely that you’re going to need less of the site time. Right? So I think this is to me why size of it is really important. I will also tell you that

00;13;30;09  –> 00;13;59;20

in the case of my Dad, and again, this is a personal experience, and it’s an n of one so clearly, maybe not reflective of the general population, but my Dad wants to sit face to face across from the investigator and have the conversation my Dad wants to understand. And, By the way, I want to be there with my Dad. I want to understand what they’re saying. My dad wants to know that the care that he’s getting is the best care. I want to know that.

00;13;59;20  –> 00;14;24;15

But and I have to tell you I feel much, notwithstanding telehealth, which I think is really important, and, by the way, I’ve had plenty of meetings with my dad’s position over the phone and over video at the end of the day, I want to sit there. I want to look at the images with him. I want to understand what is the procedure, how it’s being done, and some things are just better done at site. So this is kind of my perspective again, an n of one. But

00;14;24;15  –> 00;14;39;08

as you look at the number of trials that have taken place, particularly pivotal trials, right that have taken place a 100% virtually outside of the site you can count on, maybe one hand. So, that’s kind of where it is now.

00;14;39;08  –> 00;15;07;05

That, of course puts a burden on sites right. The burden is twofold. One, remember, actually, it was really interesting when this, not that everything is about my Dad, but in this case everything is about my Dad. When we went to the hospital, one of the challenges they had is they had shortages of beds. There’s a little bit of a spike here in in in Massachusetts, where I am around the rates of infections and the hospital was full.

00;15;07;05  –> 00;15;24;24

So they did the surgery, and they released him the next day, where ideally, they would have liked him in the hospital for 3 days. Right? So part of the challenge is just the availability of beds, the availability of space, the availability of time to conduct a to conduct, a trial to conduct a procedure, whatever the case might be.

00;15;24;24 –> 00;15;39;25

But the other one is a real issue that you mentioned, which is the staff, challenges staff shortages. And again you almost have to sort of ask the 7 Y’s right, and 5 Ys, whatever number of Y’s to get, what is the root cause here.

00;15;39;25  –> 00;16;17;03

And the would cause certainly is. Look, Covid, notwithstanding. So set aside Covid for a second. We are living in a very tight labor market, where people have an optionality, and I can work at a site and be there present in person 100% of the time. Or I can work for a sponsor or a CRO and do some of the same work, but do much more remotely and work from home. You know there might be pay differences, etc., to the clear economic factors that come about

00;16;17;03 –> 00;16;38;13

and those are much more what I consider sort of macroeconomic factors. But let’s actually sort of peel down in a little deeper back to the complexity we talked about. Now, many of these people who work at site, work at sites because they want to solve problems. They want to participate in research. They want to see patients. They don’t want to enter data into 7 different systems

00;16;38;13 –> 00;16;49;05

where all they’re doing is they’re entering data. All they’re doing is they’re transcribing data from one system to another, from one piece of paper to into a system that’s not what they want to do.

00;16;49;05 –> 00;17;07;17

And I think what we have done over the last few years with the proliferation of technologies, with every sponsor, every CRO having a different technology, and, by the way, the sites themselves also need to have their own technologies. Right? We’ve created a burden on them.

00;17;07;17 –> 00;17;38;24

I will tell you that one of the most staggering facts when we think about study coordinators. We think about staff administration and decide. But you know that over 60% of investigators that do one trial, never do a second trial because again they’re not spending time doing research, seeing patients. This is what we have to solve. You want to talk about increasing participation in clinical trials increase the participation of investigators first and foremost, right? So that’s kind of my perspective on it.

00;17;38;24 –> 00;17;46;18

It is a real challenge, as we know, for the execution of clinical research. You know some work that we did along with the SCRS, remember,

00;17;46;18 –> 00;18;11;25

68% of sites indicated that they used 4 or more sponsor systems for study. That’s kind of to your point. It’s just too much, and you know, 60% of the survey respondents who use sponsor provided technologies increased the burden on the site. So there is this multiplier effect, you know the of having the more systems, the more complex and the more difficult it is for sites, I guess

00;18;11;25 –> 00;18;35;12

And so Advarra has put together a site sponsor consortium to deal with some of these issues that are challenging in clinical research and obviously impacting time, speed, efficiency and

patient participation, site participation. How can sites and sponsors work together to become more sites and trick from your perspective?

00;18;35;12 –> 00;18;59;24

You know it’s I love how you ask me the questions, and I answer a different question really good. That’s part of the fun. So before I answer that question, Ill actually accentuate part of the challenge. So I started in clinical research 20 years ago give or take, and the first day I joined the organization I worked in.

00;18;59;24 –> 00;19;12;12

The question I was asked is, or the challenge that was faced with is, how do you accelerate study start up? And, by the way, enrollment never hit the curve that we had assumed it would hit, and at the end of the line.

00;19;12;12 –> 00;19;57;24

You know the TM is still in complete missing documents, missing visits. So compliance remains an issue, and you know, 20 plus years later it’s the same exact conversation, right? And that is

because sites and sponsors – look, of course, no question about it, therapies are more complex. You’re going to have rare disease. So by definition, it’s going to be more difficult to involve it’s going to take time. You’re going to have much more as you go into some of these new therapies you can have a lot of different challenges, which, of course, slow these things down. But all things being equal, it’s still much more expensive today to do a clinical trial than it was, even if you net out inflation,

00;19;57;24  –> 00;20;18;00

than it was 5 years ago 10 years ago. It still takes way too long. In fact, it’s slower than ever. So what is it? And to me, it’s really the disconnect between the site and the sponsor from day one. So first of all, it starts in trial design.

00;20;18;00  –> 00;20;35;08

Are the sites voices being heard during the design of the trial, during the design of the protocol? Certainly you bring a KOL in, the KOL opines, but the day to day team that actually has to enroll the patients care for the patients, are we listening to their voice enough?

00;20;35;08 –> 00;21;03;06

Are we listening to the patient enough? Are we doing the patient panels enough to see what would work for you, what wouldn’t work for you now? Of course, that’s a double edged sword, right? Because, as I said before, you may have the ability to better enroll, but it might complexify the trial even more right. But nonetheless, are we listening to the right voices, accounting for those voices as we do the trial design right? So I think that’s step one. But step 2, and a really important step is

00;21;03;06 –> 00;21;26;10

how do we enable the site and the sponsor to better connect in their day to day activities right? The less interesting stuff that you have to do, the exchanging of documents back and forth, the making sure that the site is trained, making sure that the document ends up in the ETMF

00;21;26;10 –> 00;21;42;29

making sure that the database locks on time because you clean all the patients you did everything that you needed to do, but it’s that day to day interaction that right now happens way too much through human intervention, sending the CRA to site as an example, right

00;21;42;29 –> 00;22;00;25

having an extra administrator site coordinator sitting at the computer and entering the data multiple times, right? As we said before. So how do you actually make that connection? The simple stuff, the exchange to document from the eReg. Right

00;22;00;25 –> 00;22;14;13

all the way to the ETMF. Track where things are. Know on a day to day basis, where’s the bottleneck? Did this visit occur? Did this document get exchanged? Was this training done?

00;22;14;13 –> 00;22;44;18

And you have to do that by connecting the systems much better. You have to do that by allowing the sites to use the systems that they want to use and by allowing the sponsors and the CROs to allow to use the systems that they want to use. but then connecting them, bring them together right, and not forcing one side or the other to use one system or another. Right? It’s that connection. It’s that workflow. That’s really really important.

00;22;44;18 –> 00;23;00;03

Now for that to happen, you have to have the standards, the data standards for that to happen. You have to have an agreement that I�m not going to force the system on you because I trusted the system that you have and what you’re doing is good, and

00;23;00;03 –> 00;23;15;09

I trust it’s going to connect to my system. Let’s make that connection happen right? So you have to have that happen. And, above all, you have to give the researchers the space and the time to do the work that they need to do to

00;23;15;09 –> 00;23;44;29

pre-screen the patient, to enroll the patient, to see the patient and let them really focus on those core things. But one of the things that I know frustrates CROs a lot is that every time something doesn’t go well on the trial, every time enrollment is down or a site doesn’t adhere to the protocol, and one where another deviates in some fashion or another. The big sort of proclamation is either

00;23;44;29 –> 00;24;10;07

we need to retrain the staff, you need to retrain your CRAs. You need to retrain the staff on site. That’s one. Or two, you don’t have enough resources, You don’t have the right resources. I want new resources. I want more resources, want more resources, want more people at the problem doesn’t actually solve the problem, right? So how do you actually automate some of these things? How do you solve for some of these problems by doing them remotely?

00;24;10;07 –> 00;24;26;11

Right? How do you solve for some of these problems by actually doing much better education, much better training upfront? And then, in real time, as you go through the trial without necessarily just going through a PowerPoint deck. Those are the things that you have to solve for.

00;24;26;11 –> 00;24;42;26

Yeah, no, I like. I mean, I think the point on workflow is its really important, and it’s really understanding a better understanding of a bit more empathy, and I think we’ve seen that not deliberate lack of empathy, but I think a lack of empathy and understanding about what sites are facing, and

00;24;42;26 –> 00;25;05;18

sponsors and CROs may be feeling the need to move quickly on a trial, but maybe not understanding what’s going on the other side. And then the and the multiple challenges that those sites are facing, and especially if they’re academic medical centers that are running their own institutional trials, running their own investigator initiated trials as well as commercial trials. Let me segue into patient centricity because we started talking about that, and

00;25;05;18 –> 00;25;28;01

you know mobility and connectivity have changed virtually every industry. And you know there was the hope that so you know the conversation we had earlier around decentralized modalities, and having patients connected broadly, you know, to different devices to measure different aspects of their health.

00;25;28;01 –> 00;25;50;18

What’s the reality of that sort of connected patient to clinical research? Because I think that I mean if you agree with me, I think that gets to at least a big part of patient centricity. But then, just like you were talking about the interaction between sponsors and sites. We now have this interaction between sites

00;25;50;18 –> 00;26;14;17

and patience which can be facilitated with technology, but also that makes it more complex. So I guess long, long-winded question, as we think about patient centricity. Do we look at it through a similar lens to this sort of interaction between sponsors and sites, sites and patients, or is there a different way to look at it? And how do you think it changes in 2023?

00;26;14;17 –> 00;26;51;14

Look, I think first of all, its a lesson we hopefully learned a long time ago, which is first of all listen to the patient, right? What works for them? What do they need? I believe, by the way, that many of these devices, many of the tools are really important are going to make a difference, and they’re going to accelerate clinical trials, and they’re going to give us at some point more accurate data. I’m not sure were there yet, by the way, you know, there’s the interoperability of the data. How do you capture the data, you know, etc., etc.? I think there’s still work to be done there, particularly around data standards, and I know that there are a set of organizations that are working through that.

00;26;51;14 –> 00;27;06;00

But step one is, listen to the patient, and you know again I adore my dad, so I go back to that example a lot. But I will tell you that it depends on the cohort. Right? So my dad is 83 years old, He’s happy to use his iPhone

00;27;06;00 –> 00;27;27;19

by the way every time that he makes a phone call, he’s great with it. Anytime he needs to do anything else, he calls me upstairs. Can you help me out with this? So there are set of things that certain cohorts simply wouldn’t do because they’re not familiar with the technology. They don’t trust the technology. They’re not comfortable with the technology, and they don’t trust themselves. Right in in the case of my Dad

00;27;27;19 –> 00;27;33;15

he does his blood pressure 5 times like that. Why are you doing it 5 times. It’s like I don’t know if it was if I did right the first time.

00;27;33;15 –> 00;27;36;24

I think he didnt like the reading the first time.

00;27;36;24 –> 00;28;05;27

I think, Bryan you are just spot on. He didn’t like the reading. I like that. It doesn’t improve. You gotta wait more than 30sec, you know. But the reality is, it depends on the cohort, right? So understand your patient population understand your cohort to understand what they want to do, what they can do, what they’re capable of doing right, and what fits them with that, you of what you’re trying to achieve in the in this clinical trial. So I think that that’s really important. And look again the relationship between th

00;28;05;27 –> 00;28;28;06

I’m not even gonna say the site. The relationship between the physician, the investigator, and, by the way, oftentimes it’s the nurse or the study coordinator with the patient is really really important, so keeping that connection is really important. But at the same time keeping the patient informed on.

00;28;28;06 –> 00;29;04;17

You know it’s not just read your consent form and sign it.That consent form is complicated, as can be. By the way, if there’s any area that if we really want to improve chemical trials that’s improve how we do the ICF right? They’re way too complicated way, too burdensome, have things in them that are not necessary by the way, coming from the CEO of an IRB, a company that has an IRB in it, we over complexify the ICF. But you know you have to go beyond just the ICF and standing somebody standing next to and explain to you what’s going to be done, and how it’s going to be done.

00;29;04;17 –> 00;29;16;17

You got to give the patients the opportunity to really really be informed, what does that mean? What’s the standard of care when Im doing this? What am I actually not doing right?

00;29;16;17 –> 00;29;21;12

By the way, when you’re doing a procedure. What does that procedure really look like?

00;29;21;12 –> 00;29;37;10

Show it to me. Explain it to me. I want to see a video. I want to be able to walk into it and ask questions. I want to be able to navigate and understand what’s happening to me. I think oftentimes about our longboat application, and seeing some of the 3D

00;29;37;10 –> 00;29;55;00

animations around some of the procedures. Now I understand where that needle is going and what’s being done, you know that’s meaningful to me. It’s not unknown. One of the reasons that we have such low participation in clinical trials, there are multiple reasons, but one of them is

00;29;55;00 –> 00;30;06;00

I don’t know what I don’t know right? I know what this thing is. Another one is distrust of what’s being done and how it’s being done. And, by the way, what’s going to get done with the data

00;30;06;00 –> 00;30;21;04

Building that trust building that familiarity providing that knowledge and information is really really important. So, and that’s the role of the investigator, or the side coordinator or the nurse. And that’s why the site is so important.

00;30;21;04 –> 00;30;43;11

Yeah, that question of participation. I think it, you know this is very helpful discussion around patient engagement, but it also relates to, and you mentioned it earlier, it relates to diversity, equity, and inclusion within clinical research. How impactful is, how much do these, you know this complex informed consent do

00;30;43;11 –> 00;31;10;00

You know the nature of the site and the nature of the staff at the site? How much does that impact minority participation in clinical research? And you know, and just one statistic from the FDA that you know, when you think about population, we’ve got, you know, I think there’s about 25% minority participation in clinical research, whereas you know that the population is closer to 50%, you know. So,

00;31;10;00 –> 00;31;15;05

by the way, it’s 25% of the 2% that actually participates in clinical trials.

00;31;15;05 –> 00;31;25;17

Exactly and there’s a lot of factors. But I think you brought up some. I’m going to just try to understand. Should sites be doing things differently?

00;31;25;17 –> 00;31;48;06

should sponsors be doing things differently, everything from informed consent to the nature of videos to the nature of PIs. How do you think that we can do better? Because it is? It is definitely a focus of many life sciences companies, and you know the industry broadly is to increase minority participation, not only because it’s good for society, but I think it’s good for business, right?

00;31;48;06 –> 00;32;07;23

definitively, you know, so Ill start with a more. I guess it’s a it’s much less pedantic or nuanced or small, it’s the big picture. And, by the way, one of our large site clients, an Academic Medical Center has done a phenomenal job in this. you want minority, participation

00;32;07;23 –> 00;32;21;23

in clinical trials, conducting clinical trials with the minority Population sits where they live, where they work with, they conduct their life every day. and, by the way, it’s not just minority. It’s disadvantaged in whatever form, right

00;32;21;23 –> 00;32;59;13

conduct the clinical trials – go to them and by go to them now again, back to the conversation we had earlier, It doesn’t mean go to their home leverage the Community Health Center, leverage their local physicians. This is what’s going to increase participation more than anything else. I truly believe that. And one of the things that again, that client of ours did really effectively is to advocate for participation in the vaccine trial for Covid. What they did is they actually went to the community leaders in the minority population areas, the charge leaders, people that are trusted by the community

00;32;59;13 –> 00;33;11;07

and they had them actually talk about why vaccination is so important. They had them talk about: why participate in the clinical trial is going to give them an option. It’s going to give them an opportunity

00;33;11;07 –> 00;33;29;19

it’s going to help with their care. So go to the local community center,  leverage the community leaders leverage the community, healthcare leaders, the community sites. That’s going to probably make a bigger difference than anything else. Now, of course, you can say. Well, look.

00;33;29;19 –> 00;33;50;27

you kind of have to go where the patients are. Those minority population centers have patients of every type, from every disease area to every therapeutic area in need, and we don’t go to them enough. We ask them to come to us, and we discount the fact that either they don’t trust the doctor that’s

00;33;50;27 –> 00;34;06;22

at the center 50 miles away. By the way, they don’t have transportation with which to get to, and getting into an Uber, yeah, we’ll pay for you, Uber. And in fact, we’ll even arrange it. It’s not something that they’re necessarily comfortable with. Right? So I think that’s one. I think 2 is

00;34;06;22 –> 00;34;33;14

speak to them in their language. By the way, I didn’t mean to play on words here, because there is a language component to it, you know more and more what we’re seeing is every ICF is translated into at least one other language right? Speak their language, give them the opportunity to have a whether the documentation, or whether it’s the nurse or the physician on site have a translator, and make sure that actually their language is spoken.

00;34;33;14 –> 00;35;03;21

but they speak their language, I also mean Don’t, speak to them in terms that only a scientist or  their physician, understands speak to them in terms the laymans understands. Look, and this, by the way, has nothing to do with minority population. It has to do with every population type. I read my Dads protocol, and I was kind of scratching my head on a few of those things Im like Im not sure what that means. I’m not sure how that actually gets conducted, you know, etc. And for that to happen you have to use visuals. You have to use video. You have to use

00;35;03;21 –> 00;35;28;03

verbal for sure. You have to give people the opportunity to do it at their pace, and there are a set of tools to use for that. The ICF in of itself is a much bigger conversation. Look, I continue to believe that this is going to be really, It’s not going to sit well with a certain cohort that may listen to this: that cohort being JDs, which is:

00;35;28;03 –> 00;35;48;16

whenever you have too many lawyers touching the ICF, what you’re going to have is something that’s highly restrictive. When you have too many lawyers touching the contract, that or the site agreement, you’re going to have something that’s way too complicated right? When everything is driven from the perspective of

00;35;48;16 –> 00;36;06;04

the lawyer or the perspective of the statistician, you’re losing what really counts here, which is what resonates with the patient, what works for them. Look, I get the liability. I get all the safeguards that you have to have in place, but we have to find balance. We have to figure out how to make this friendlier

00;36;06;04 –> 00;36;28;04

That I mean, I, that that makes a lot of sense, and I agree with you completely. I think there are there are tools, you know, that that vendors provide to identify patients, to identify sites, to provide information, a platform like Longboat, but without that human factor and thinking about. You know that you sometimes have

00;36;28;04 –> 00;36;57;28

patients that participate, that have been historically, not only underrepresented, but historically distrustful of clinical research. And so there has to be real effort. It’s not, it’s not merely translating an ICF into a different language. It’s a broader question, I think. Let’s segue into data and analytics, because I don’t think any conversation around clinical research can take place without some sort of discussion around data and analytics. I guess

00;36;57;28 –> 00;37;09;00

maybe at a high level, there are a lot of interesting trends, I mean I’ve been playing with the Chatbot recently as we talked about.

00;37;09;00 –> 00;37;10;28

So has my kid when he was writing his paper.

00;37;10;28 –> 00;37;48;24

It’s pretty cool. It is really cool, and it is I mean it is pretty revolutionary. I didn’t ask it to ask me questions I should ask you. But when we talk about data enabled R&D, and we think about

artificial intelligence, machine learning and other types of technology. When you think about AI, and how it can improve the clinical research process, maybe what are the things that come to mind? Or we can talk about broader data, but Im curious as we think about these innovations that are coming, does it make the process better? Does it improve clinical research? Can it improve clinical research, maybe

00;37;48;24 –> 00;37;56;20

thinking about? And where are those pain points that this sort of advanced data and analytics  capability could really be helpful.

00;37;56;20 –> 00;38;11;10

Hold on, I’m. I’m typing all that into the chat box to give you the answer so bear with me. I type it all in. you know it’s a clearly game changing. The question is, what game is it changing? And how fast will it change the game? I think, on the

00;38;11;10 –> 00;38;29;01

AI, again, this is an area where on the R is moving faster than on the D. I think it really is changing the way science is done. You know. You can start with the you know the Genome Project and move on and on and on right. So for sure, I believe that the impact is first and foremost on the science. The

00;38;29;01 –> 00;39;08;09

challenge on the development side is, First of all, there’s so many data sources. There’s lack of standardization of how that data gets ingested gets reported, there are overlaps. The question is, what is the purpose that you really trying to achieve? I believe there’s no one data source that gives you the answers to everything, I think, and we see it in Pharma when they look at their development process to do patient identification. Yeah, ultimately they’re going into the EM, EHR, but they’re leveraging multiple providers and vendors to figure out how to do the analytics around that, and what other data sources

00;39;08;09 –> 00;39;33;08

they can actually bring in. So I think that that’s still a work in progress. I would tell you that, you know, and then this is an area that we look at. I believe that the first and foremost important opportunity around finding efficiency and clinical trials and optimizing clinical trials is leverage some of the technologies, whether it’s machine learning, AI,

00;39;33;08 –> 00;39;53;15

just biggest data made into smaller data to actually optimize processes, to automate certain processes where human intervention just slows things down. Whether it’s you know it’s interesting. If for those of you who’ve done clinical trials for a long time I think about the database programming, and you’re actually double programming the database

00;39;53;15 –> 00;40;02;04

that doesn’t seem particularly efficient to me. Right. Think about some of the QC, when you look at the tables, listings, figures, etc.

00;40;02;04 –> 00;40;31;20

Can’t we actually find a different way, more of a machine learning way, AI way to allow the QC work? So actually, apply some of this automation and some of this ingestionable data. And then the parsing out of that data to process improvement. That is a low hanging fruit. That is something that’s tried. That’s tested. Don’t want to solve the biggest problem. Run to solve the problem that can be solved with what we have right. So to me that’s a real opportunity.

00;40;31;20 –> 00;40;53;10

You know that, and that that makes a lot of sense. I mean, I think one thing to think about is that you know, To be used in clinical research, AI applications have to be validated and regulated, and they’re regulated by the FDA, which ensures that the safe and accurate, but also probably slows the adoption of technology and the usefulness of technology and data within clinical research. It also

00;40;53;10 –> 00;41;25;02

to the point that we made around patient centricity. You know there is also a question of just how much patient data that sponsors want as part of the as part of clinical research. And you know, so it does. Yeah, there is a lot of opportunity. But with opportunity and with this plethora of devices and the exponential amount of information, there’s a lot of interesting questions that presumably need to be asked

00;41;25;02 –> 00;41;39;18

  1. You know all the constituents within this process to figure out what works, what could work, and what can’t work, and what the risks and opportunities are associated with that with all of that stuff. It’s not so simple just because I have this

00;41;39;18 –> 00;41;46;27

collection capability. And I can generate a lot of data that it means Im just going to throw it into the to the trial. Right?

00;41;46;27 –> 00;42;01;25

The solution is less about the data, because I believe there’s so much data out there, and then it’s good quality data. Yes, not all of it is great quality, but it’s good quality data. The source is trusted, etc. To me it’s about the platform, the platform which you ingest that data,

00;42;01;25 –> 00;42;14;01

curate that data, report on that data. That’s the important thing, because Pharma is never going to come to any one company and say, you’re the sole provider of data that we’re going to use in order to identify patients.

00;42;14;01 –> 00;42;30;26

But it’s not going to happen. They have their own experiences with sites. They have their own experiences with various recruitment agencies, and at the end of the day they’re going to leverage data that they have in house they can buy from the outside for multiple sources.

00;42;30;26 –> 00;42;41;14

It’s: How do you then take all these data and put it into a place where it can be standardized into a place where it can actually be really useful, and quickly

00;42;41;14 –> 00;43;11;00

parsed into whatever pieces whatever slices you want to parse it into. I think that’s the real opportunity. And for that you also have to, you know, standardize some things, standardize the nomenclature, the taxonomy, all those things right. So I think, notwithstanding the availability of data out there. I think ultimately, it’s the platform with which you ingest all that data that really matters. But, Bryan, you know this is just phenomenal. It gives me the opportunity to actually flip the tables on you, because

00;43;11;00 –> 00;43;25;07

is, that might be mixing metaphors. Sorry, but is that, for someone who dabbles in data every single day, I mean part of your job is looking at some of these partnerships that we have around data, and how we build our own data assets, and whether it’s SiteIQ or whatever the case might be.

00;43;25;07 –> 00;43;29;28

What are you seeing? What resistance and what uptake are you seeing?

00;43;29;28 –> 00;43;53;24

Yeah, look, I mean, I think that it’s a good question. I love having flip the script. It’s always fun. Look there is you know, when we kind of parse the different areas of where data is important, you know, there’s real world evidence, right, which can help us better identify patients. Better look at retrospective impacts of drugs on the real world population.

00;43;53;24 –> 00;44;11;07

You know, identify perspective patients for clinical research, all of those things that are important, right? And the work that we’re doing in terms of identifying sites, I think, and you know, through SiteIQ, and some of the other stuff, to make sure that you know this site is the best doesn’t mean it’s a good site or a bad site, but it’s the best site

00;44;11;07 –> 00;44;40;22

for this particular trial. We talked about patient centricity and how gathering data from patients could be interested in. And again it gives them a hybrid approach towards participating in clinical research. Right? Not don’t go to a site or come to a site exclusively, but a little bit of both. And I’m like you’re going to like, with your Dad and the blood pressure, you might not like what he read, but that’s a lot easier doing it at home than going into a medical office to do it, so that that data becomes important

00;44;40;22 –> 00;44;58;03

and that’s around improved data collection and data management. We talked about recruitment, you know. There’s the idea of cost savings, you know, can we have synthetic control arms? Can we use data and analytics to look at error rates and decide that you know this this particular

00;44;58;03 –> 00;45;22;12

trial, this particular site, this particular patient population operates differently? So I do think there’s a scoring and measurement aspect to the things that we’re talking about. That’s really important. And the other thing that’s very clear is that there’s no dominant player that has the perfect data set, and it’s the interaction of multiple datasets to answer specific use cases that makes data valuable.

00;45;22;12 –> 00;45;45;09

It’s not a one size fits all. So I think we’re making efforts on our end, but we also recognize that we’re part of a broader ecosystem, and we need to work with our clients and need to work with regulators to see what data should be included, what data could be included to improve the process, because back to your back to the earlier discussion there is a lot of complexity and every piece of technology in every new data source

00;45;45;09 –> 00;46;08;01

it has the opportunity to simplify, but it actually has the opportunity to complexify at the same time. So you know, managing workflow like you said before, is really critical, and there aren’t many companies out there that are really thinking about the totality of the workflow of clinical research, and how to make clinical research operate more efficiently. And I think we, you know, I agree.

00;46;08;01 –> 00;46;21;14

So look, we could probably go on and have this conversation for another hour, which we might after the end of the podcast, but given that we are in a podcast. We probably have to wrap things up. So, first of all, thank you.

00;46;21;14 –> 00;46;26;23

But I thought the Internet had unlimited bandwidth. We could talk for hours. We don’t have to ever stop.

00;46;26;23 –> 00;46;29;13

We don’t, but it’s just a question of what what’s going to be packaged right?

00;46;29;13 –> 00;46;49;17

try with these podcasts to bring out interesting information and information that’s relevant, we also we’re setting it up this podcast around a trend report that we put out, and I think we’ve covered each of those trends in different ways and through different conversations during this discussion. So, thank you for that, and thanks for, thanks for participating.

00;46;49;17 –> 00;47;04;14

Well have to remember that. And this is something we talked about. We talk about here every day at Advarra, right, we come to work because what we do ultimately has an impact on the patient, whether it’s today, whether it’s 10 years from now, the things that we do.

00;47;04;14 –> 00;47;30;21

we do because we want to ultimately have an impact on the patient and make the world a healthier place, and I think we all have a role in that, and Ill tell you, I could not be prouder to be a part of Advarra, but even more than that, I couldn’t be prouder to be part of the clinical research industry. It’s a phenomenal place to be, and for any of you who are listening, who are part of clinical research, thank you. Thank you for what you do every day.

00;47;30;21 –> 00;47;47;12

Thank you, Gadi, and thank you all for listening. If you enjoyed today’s episode, Keep a look out on Advarras social channels and Advarra.com for our next discussion.

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