Latest / Lab to Lives / Decentralized Clinical Trials as Treatment Options with Ewa Lindqvist

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Decentralized Clinical Trials as Treatment Options with Ewa Lindqvist · Lab to Lives

• 0:13
  Speaker 1: You're listening to Transformation in Trials.
• 0:16
  Speaker 1: Welcome to Transformation in Trials.
• 0:23
  Speaker 1: This is a podcast exploring all things transformational in clinical trials.
• 0:27
  Speaker 1: Everything is off limits on the show and we will have guests from the whole spectrum of the clinical trials community and we're your hosts, ivana and Sam.
• 0:35
  Speaker 1: Welcome to another episode of Transformation in Trials.
• 0:40
  Speaker 1: Today, in the studio with us, we have Eva Lindquist, and Eva is on a mission to make patients early adopters of their own health.
• 0:49
  Speaker 1: Hi, eva.
• 0:51
  Speaker 2: Hi, ivana, nice to meet you today.
• 0:54
  Speaker 1: Today we're going to dive into the topic of clinical trial as a care option and we're going to talk more about decentralized clinical trials.
• 1:01
  Speaker 1: But before we really dive into the conversation, can you help our audience understand where are we as an industry when it comes to decentralized clinical trials?
• 1:12
  Speaker 2: So I think we are in a state at the moment which is a bit of a post pandemic, trying to find our balance in the industry in terms of DCTs.
• 1:25
  Speaker 2: So I think, when it comes to decentralization of clinical trials as a strategy for conducting clinical trials whether they fully decentralized or hybrid there were a lot of smart people already before the pandemic that worked on this and were engaged and were driving really DCTs forward.
• 1:51
  Speaker 2: And then I think a lot of people kind of understood the benefits during the pandemic and we saw an increased interest in decentralization of clinical trials and I think there was a bit of perhaps maybe even naive expectation that this explosive effect of DCTs would continue after the pandemic.
• 2:20
  Speaker 2: And I think we kind of realized that that's not happened, although we're a lot further ahead than we were five years ago, for example.
• 2:31
  Speaker 2: So in terms of DCTs, there is now a lot of interest from the patient perspective.
• 2:38
  Speaker 2: There's a lot of interest as well from the sponsor perspective.
• 2:46
  Speaker 2: We are getting more and more questions about the benefits of it.
• 2:50
  Speaker 2: We're seeing a lot more sponsor companies and pharma companies, biotechs, looking at implementing strategies, but I personally don't think it's going fast enough.
• 3:03
  Speaker 2: There's so many benefits.
• 3:04
  Speaker 2: We really should moving at speed here, because there's really, really a lot of gains and a lot of value in implementing DCTs.
• 3:13
  Speaker 2: So I would like to see really decision makers getting ahead of themselves, being a bit more brave and embracing the benefits of the DCT.
• 3:27
  Speaker 2: There's still a lot of resistance, there's still a lot of hesitancy from the pharma companies and the biotechs, which is to be expected when you'd have such a huge change in an industry.
• 3:41
  Speaker 2: It's, I would say, classic change management in terms of you have to work hard on what's in it for me peace to get over that resistance and hesitancy.
• 3:59
  Speaker 1: Maybe we could talk more about.
• 4:01
  Speaker 1: What are these benefits that we're still leaving on the table?
• 4:04
  Speaker 2: So yeah, so there's a lot of benefits.
• 4:06
  Speaker 2: I really liked your introduction right, because for me, early adoption of your own health is a concept that I like to really drive when it comes to DCTs.
• 4:19
  Speaker 2: So I think the decentralized clinical trials offer a lot of patient benefits.
• 4:26
  Speaker 2: So, looking at it from a care option perspective, I think being an early adopter, being curious about what treatment options are available to you and not always just settling for something good enough that's already on the market, but actually looking at what's in clinical trials, are there any options for me to be treated for whatever illness or condition I have with something that's not marketed yet, with something that's in clinical trials, with something that the smartest people in the world at the moment are really looking at, that they are working on.
• 5:12
  Speaker 2: I mean, it's a really, really great opportunity to take part of the latest, greatest and the best, to look into a clinical trial as a care option really.
• 5:23
  Speaker 2: And for me it shouldn't just be a privilege for those who live close to university hospital, and this is where I think technology solutions like Thread, which allow the implementation of decentralization, really play a significant part.
• 5:41
  Speaker 2: So by being able to offer clinical trials in a wide geography and not just limited to the actual people who live in the vicinity of a one or two, three hour drive from a university hospital.
• 6:00
  Speaker 2: So it should be something that's available to more people, no matter where you live, where you work, and so that's really the benefit for the patients that you actually get the opportunity and the chance to participate in a clinical trial, no matter where you're located.
• 6:22
  Speaker 1: I would be curious to learn more about well, making that availability happen to a broader range of people.
• 6:27
  Speaker 1: What does that require?
• 6:28
  Speaker 1: How do you make these digitalized clinical trials happen?
• 6:32
  Speaker 2: So you really need good technology right and basically you need a way for patients to report their data remotely.
• 6:44
  Speaker 2: So Typically, when you design a clinical trial, you'll have endpoints and they will consist of.
• 6:54
  Speaker 2: In some trials they will consist of different ECOAs.
• 7:00
  Speaker 2: So patient reported outcomes, clinical reported outcomes.
• 7:03
  Speaker 2: But if you focus on the patient reported outcomes, such as different scales and questionnaires and diaries, the traditional way of doing this would be that you would get a paper diary, for example.
• 7:17
  Speaker 2: You'd have to complete it at home every day and you would have a clinic visit once a month and then you would bring that back to your physician.
• 7:25
  Speaker 2: They will take a look at it and with the technology the thread offers, the patient will have this as an app.
• 7:33
  Speaker 2: So the patient will have access to it as an app.
• 7:37
  Speaker 2: They can enter all their data in real time when it happens and that data is instantly available through the technology both to the treating physician so that they can actually have real time reported data to make important safety decisions for the patient, such as do we need to change the dose of the drug?
• 7:59
  Speaker 2: Do we need to increase or decrease the drug dose?
• 8:01
  Speaker 2: Do we need to stop it all entirely?
• 8:04
  Speaker 2: Do we need to take care of something else.
• 8:07
  Speaker 2: Do I need to call the patient and talk to them?
• 8:11
  Speaker 2: And it's always real time data.
• 8:13
  Speaker 2: And the other benefit of decentralized trials which I think doesn't get enough credit is the benefits to the sponsor.
• 8:26
  Speaker 2: So not only does the site and the treating physician have direct access to real time data, so does the sponsor companies, and the benefit of that is that they can see trends and look at the data instantly to understand.
• 8:45
  Speaker 2: You know what's the next step.
• 8:48
  Speaker 2: They can make important decisions much quicker based on that data.
• 8:54
  Speaker 2: Imagine the traditional method where a patient comes in once a month and then already then is some of your data one month old.
• 9:04
  Speaker 2: Then you need to allow time for the site staff at the clinic to enter that data into a system.
• 9:11
  Speaker 2: Then you have to wait for somebody to just source data verification to make sure that the data that was entered was actually correct and based on the source, and only after that data has been cleaned can the sponsor look at it to make important decisions, and you lose a lot of time.
• 9:32
  Speaker 2: Without technology they have it instantly available, right?
• 9:40
  Speaker 2: So one of the things that gets a little bit yeah, I think overshadowed is the cost benefit to our sponsors.
• 9:49
  Speaker 2: So when we talk about DCT, there's a lot of focus on patient centricity, and rightly so.
• 9:56
  Speaker 2: Absolutely that's also my driver.
• 10:00
  Speaker 2: I think it's important to understand that there is a cost benefit to drug development.
• 10:05
  Speaker 2: When I say cost, I always look at it as a cost and price discussion, right.
• 10:16
  Speaker 2: So what a lot of sponsor companies become shocked with is the price of the technology.
• 10:23
  Speaker 2: So when they're doing a clinical trial, they will get one cost for a traditional trial and then it will be priced with technology if you want to make it as a DCT, right, and they will realize that actually technology has a price.
• 10:41
  Speaker 2: And so there's this misconception that it will be cheaper to run a trial.
• 10:48
  Speaker 2: Oh, I see, yeah, but it's not right.
• 10:50
  Speaker 2: So the cost saving of a DCT is not that a clinical trial will be necessarily cheaper for a single trial, and that's why I'm saying the cost versus price piece right.
• 11:04
  Speaker 2: So, the price tag might be higher, and is likely to be higher, but the cost of your entire drug development program and the go-to market benefits that you will hopefully see with a DCT is going to save you cost overall.
• 11:27
  Speaker 2: So the fact that you can have real-time access to data, making decisions faster on your pipeline and where you want to focus your resources and the investment money that you've got from a venture capital firm or whatever being able to make those decisions quicker by having a DCT model is, on the other end, going to save you a lot of money, whether it's to develop your phase two program and move into phase three and start designing a protocol, or whether it's to kill the entire pipeline and move a couple of drugs out of there and not progress them anymore.
• 12:03
  Speaker 2: Making those decisions earlier will save pharma companies, the biotechs millions.
• 12:10
  Speaker 2: So that's where the cost saving piece actually comes into play, and by decentralizing your trial, you reach more patients, you have better data.
• 12:21
  Speaker 2: Because you have more diverse data, you'll get your patients in quicker, you get your data quicker, you can do your analysis quicker and overall, you'll be able to go to market quicker, hopefully, and that's where you're going to save your money.
• 12:36
  Speaker 1: That makes sense.
• 12:37
  Speaker 1: I am curious when you're describing the setup where you can see the data instantaneously of how the patient is doing, you can evaluate the dosage, you can evaluate the safety profile on this patient.
• 12:49
  Speaker 1: To me, it sounds like the same kind of monitoring could also be applied during treatment and not just during clinical trials.
• 12:57
  Speaker 1: Could we use a similar setup, technology wise, for drugs that are already approved on the market and as part of the healthcare system?
• 13:08
  Speaker 2: Absolutely.
• 13:08
  Speaker 2: Yes, we do a lot of real world studies, so I mean there's from the regulators a lot more pressure nowadays than even 10 or 15 years ago on real world data, real world evidence.
• 13:20
  Speaker 2: You know, like face studies, we'll do long term follow up studies, and so there's definitely a very important space for technology like threat in those types of studies.
• 13:34
  Speaker 2: Absolutely, we do plenty of them.
• 13:38
  Speaker 2: We have several successful projects like that and it's certainly a very good way to use the threat platform in terms of collecting real world evidence and data from treatments that are already on the market.
• 13:57
  Speaker 2: Yeah, thanks for bringing that up, ivana, very important point.
• 14:00
  Speaker 1: Yeah, also, I want to kind of look back to the patient side of things when it comes to decentralized clinical trials, because we spoke about some of the resistance that there may be to decentralized clinical trials.
• 14:15
  Speaker 1: Would you find that that resistance comes from the patient side more, or does it come from the sponsor side?
• 14:23
  Speaker 2: I would say mainly from the sponsor side, absolutely so.
• 14:27
  Speaker 2: I think there is still a lot of hesitancy and resistance and, I would say, a little bit of a fear in terms of the technology.
• 14:40
  Speaker 2: I think we have a competency gap in the industry that needs to be filled actually.
• 14:46
  Speaker 2: So, for all those young students out there that are wondering what they are going to do in the future, I would suggest that they start learning more about technology and clinical trials versus regulations, because I think, having been myself nearly two decades in the clinical trials industry, with majority of it in a Sierra background, I can see where the companies are coming from and what their worry is, but it's not really necessary and needed.
• 15:23
  Speaker 2: I kind of want to overcome that.
• 15:25
  Speaker 2: In terms of the regulators are nowadays, I would say, quite switched on.
• 15:31
  Speaker 2: They are really promoting and really making it I wouldn't say easy, but they're open to and they're curious about and they are encouraging the use of technologies and remote patient monitoring and the decentralization of clinical trials, because there are benefits to patients, because there are benefits to society.
• 15:58
  Speaker 2: I think when I started in the industry nearly two decades ago, there was this perception that regulators were our enemy and they were very rigid and they were very old fashioned.
• 16:12
  Speaker 2: We were driving innovation and trying new things, and it was difficult.
• 16:18
  Speaker 2: I would almost like to be brave enough to say it's the opposite today.
• 16:24
  Speaker 2: So the regulators are really kind of on our side and what we're seeing is that the pharma companies and the biotechs who are the decision makers ultimately on whether they want to introduce DCT strategies, are hesitant because they are not comfortable, maybe, with the regulations.
• 16:46
  Speaker 2: And when we speak to individual customers, their regulatory departments and their compliance departments are very, very nervous always and they very often and nearly every time choose to interpret regulations more strict than they have to be, which I think is the big blocker here.
• 17:09
  Speaker 2: We really need them to be brave and open to that things are changing and that things are not the way they were always going to be.
• 17:22
  Speaker 2: That way they were always.
• 17:23
  Speaker 2: And I think, from my perspective, we work in an innovation space and it's really funny, when you try and look at it from this perspective right, that in the pharma and biotech industry we're trying to find new treatments for patients and people to feel better.
• 17:49
  Speaker 2: So it's a huge bunch of people who are scientists, innovators, very smart people, and then we come to clinical trials and want to run a DCT, and we're in this state of well, we'd rather be safe than sorry, which is indirect contradiction to a space of innovation which is like really the total opposite, and of course, we need to be rather safe than sorry.
• 18:17
  Speaker 2: We're talking about patients and health and there's a lot of money involved.
• 18:21
  Speaker 2: There's a lot of investment at stake.
• 18:23
  Speaker 2: There's people's health at stake.
• 18:27
  Speaker 2: So, you know, there's probably a few people who will listen to this, who will think I'm crazy saying that you know it's not right to be better safe than sorry.
• 18:38
  Speaker 2: I'm not saying that we put all that aside, but I think there's another way of thinking about it and it's about being a little bit more brave and trusting the regulations that the regulators have put up and not always leaning on the your own interpretation of the safest way of what the regulations say, because you just limit yourself and you're not going to get those treatments out to your patients to benefit your patients and society quickly enough.
• 19:11
  Speaker 1: And I think that's a very important point.
• 19:12
  Speaker 1: We have this fear of compliance that is different from the actual regulation that's out there, where sometimes the regulators are further ahead and braver than the industry as a whole.
• 19:24
  Speaker 1: We just really don't trust that.
• 19:25
  Speaker 1: Oh, do they really mean that?
• 19:26
  Speaker 1: Can we really trust that, when they change the rules, that we are allowed to follow the new rules?
• 19:32
  Speaker 1: We had an episode where we dove into expanded access programs and the willingness of regulatory agencies to actually allow patients access to drugs before they are completed their clinical trials, and I was also thinking about this angle of real-world evidence with the platform that you are talking about.
• 19:56
  Speaker 1: That could also be a way to safely expose a larger population to a drug before it's completely finished, in a still controlled environment but without quite the same rigidity as we have in clinical trials.
• 20:11
  Speaker 1: I would be curious to hear if you had those kinds of applications where it's not a clinical setting, it's not a marketed drug, but it's kind of in between, to provide patients access before the drug is actually ready.
• 20:26
  Speaker 2: Yeah, absolutely.
• 20:27
  Speaker 2: So we can use that technology, that ThreadOffice, also for that.
• 20:31
  Speaker 2: So, at the end of the day, what ThreadOffice is?
• 20:33
  Speaker 2: A way to capture data in real time via an app where every patient can download the app from the app stores onto your own phone, or you can be provisioned a phone with the app on it already if you don't want to have it on the same device.
• 20:46
  Speaker 2: So you have both options and we can collect any data that you might want to collect from the patients via this app.
• 20:56
  Speaker 2: And this all feeds into a portal which is available for the sites and the clinician and they can enter data on their web-based portal.
• 21:06
  Speaker 2: And all that data can be aggregated and processed and be available at any time in real time to the sponsor companies and their data management teams and statisticians etc.
• 21:22
  Speaker 2: To continuously look at.
• 21:23
  Speaker 2: So you can use it from an operational perspective to track compliance of patient reported data and completion of different tools and activities by the patients, but also how many sites are activated, how many patients are in the study, things like that.
• 21:44
  Speaker 2: But you can then also look at the actual data for things like safety, efficacy and whatever other endpoints you may be collecting through the app in those categories to make really, really quick decisions that will benefit both the patients but also the actual company that's testing their drug.
• 22:05
  Speaker 1: So, the way that I'm hearing it, this platform can actually work with different kinds of clinical technology landscapes, depending on what the sponsor company has.
• 22:14
  Speaker 1: It seems like you're pretty flexible in the ways that data can be feeded into other systems.
• 22:20
  Speaker 1: Is that correctly understood?
• 22:21
  Speaker 2: Yeah, so we have, absolutely, we have, you know, we have.
• 22:25
  Speaker 2: First of all, we have the ability to integrate with lots of wearables.
• 22:28
  Speaker 2: So if there's data that you want to collect it's not just going to be entered on an app by a patient we can integrate with the cometers, with Fitbits, with like there's over 100 different devices that we can integrate with, which is super cool.
• 22:51
  Speaker 2: And then we can also feed data into, like the traditional EDC systems.
• 22:59
  Speaker 2: So, you know, in many hybrid settings, for example, if you have a hybrid DCT which is not fully decentralized, there could still be a traditional EDC system where data is being entered.
• 23:10
  Speaker 2: So there may be a logic in terms of sending our data over to that EDC, for example.
• 23:20
  Speaker 2: So we can integrate with those systems.
• 23:24
  Speaker 2: Yeah, I would prefer.
• 23:27
  Speaker 1: Yeah, that's so cool.
• 23:28
  Speaker 1: I had no idea that there are over 100 different devices in the wearable space.
• 23:33
  Speaker 1: That's impressive.
• 23:34
  Speaker 2: Oh yeah, there's lots that measure everything from temperature to heart rate to, yeah, to cometers and all sorts of stuff.
• 23:44
  Speaker 2: Yeah.
• 23:45
  Speaker 1: This may be a bit of a detailed question, but I would be curious.
• 23:48
  Speaker 1: How do you get that data from the wearable that may be in the format that the wearable has selected?
• 23:55
  Speaker 1: How do you get that into an EDC which has a more standardized meter data definition?
• 24:06
  Speaker 2: There's very smart people who sit and work on those integrations.
• 24:10
  Speaker 2: At Threads we are also offering an entire library actually.
• 24:17
  Speaker 2: So basically there's like a drag and drop model.
• 24:22
  Speaker 2: So if the standardized wearables and integrations, it's already sitting on a shelf ready to be used.
• 24:30
  Speaker 2: So there's lots of programming going on in the back end and that makes it all fit.
• 24:35
  Speaker 2: It is complex, it's incredibly complex and it's actually been one of the pain points for a lot of companies like that.
• 24:42
  Speaker 2: I think we've come sort of a step ahead thread where we can offer those types of solutions that make it a lot easier and quicker to work with integrations.
• 24:55
  Speaker 2: So expanding that libraries on our roadmap, which I'm super excited about because it's really, I think, something that's going to make a difference to a lot of our customers who may want to integrate with EDCs or different wearables.
• 25:13
  Speaker 1: That is impressive.
• 25:14
  Speaker 1: I mean bridging that gap.
• 25:15
  Speaker 1: That's an innovation in itself.
• 25:19
  Speaker 2: Absolutely.
• 25:22
  Speaker 1: I would be curious to learn more about you.
• 25:24
  Speaker 1: How did you get into the space?
• 25:25
  Speaker 1: What have you been up to the past 20 years in pharma?
• 25:28
  Speaker 1: How did you end up with Thread?
• 25:33
  Speaker 2: So I started my career 2004 as an entry level CRA and I did, like the clinical operations IKEA manual I call it because I'm based in Sweden.
• 25:46
  Speaker 2: So I kind of did step one, step two.
• 25:49
  Speaker 2: I went by the book.
• 25:52
  Speaker 2: I was an entry level CRA CRA1, cra2, senior CRA, lead CRA, clinical trial manager, project manager, project director and then I had the privilege of being head of the Nordics and the clinical operations department for almost five years at one of the global CRs, which was a great time because it was during the pandemic.
• 26:21
  Speaker 2: I always I like when things get real.
• 26:30
  Speaker 2: So I had the privilege of being a head of that department during the pandemic, where I had to lead that whole team in terms of having 80% of my staff being CRAs, travelling across different countries, juggling that and then making sure there was business continuity as well.
• 26:56
  Speaker 2: So that was fun.
• 27:00
  Speaker 2: I'm good in the crisis mode.
• 27:01
  Speaker 2: That's what I realized in that time.
• 27:07
  Speaker 2: And so but like even before then, as part of my job there, I used to support a lot, of, a lot of bits that came in to that CRO from companies even before the pandemic in terms of digital health solutions.
• 27:26
  Speaker 2: And because I'm based in the south of Sweden, it's a hub and an area of a lot of startups and innovation companies.
• 27:34
  Speaker 2: So I had part, you know, I took part in this ecosystem of really cool digital innovation in the health space that I would support the CRO I worked for with implementing solutions and looking at options and trying to be creative with the different proposals that we were putting together for different customers.
• 27:57
  Speaker 2: So that's kind of how I started my interest in the digital health space.
• 28:02
  Speaker 2: And then, you know, sweden was quite early with implementing virtual health and health apps and I started taking myself and my kids to the doctor digitally very, very early on and there was some remote patient monitoring in that real life, real world setting happening already.
• 28:28
  Speaker 2: So I kind of always had that interest in digitalization and digital tools and technology and how to use that and also kind of when I started working a lot, having my children at the same time, realizing that we need to offer easier ways for people in general, but also women specifically, to participate in clinical trials.
• 29:04
  Speaker 2: So not only the whole being an early adopter of your health, but there's that added benefit.
• 29:09
  Speaker 2: I think as well that we need to get more women into clinical trials as well, because traditionally, you know, women are underrepresented and it's a fact that you know there's not enough women in the trials to actually give a fair picture of how a drug works, because it's just not enough women in there to have good data.
• 29:33
  Speaker 2: And I think one of the reasons is really that you know, traditionally in the world women are caregivers.
• 29:39
  Speaker 2: We take care of the children, we take care of the house.
• 29:43
  Speaker 2: Maybe that doesn't look the same in every country, everywhere in the world, but if you look at the world as a whole, that's the case.
• 29:51
  Speaker 2: And even in the countries where women are working full time and not taking care of the kids and they have a husband who cooks, we still are busy.
• 29:59
  Speaker 2: And like somebody like me, like myself, I would prefer to report my data from my phone every day and not have to like write it on a piece of paper to bring it into hospital once a month that I don't have time to go to because I need to have a babysitter, or I need to take time off work, I need to get a dog sitter.
• 30:20
  Speaker 2: I don't know whatever is going on in your life right, let alone in parts of the world where you know, where women are busy full time with cooking, cleaning and taking care of the village right, or the grandkids or the whatever.
• 30:36
  Speaker 2: So there isn't the opportunity, they don't have the luxury to think about their health and set time aside to regularly attend clinics.
• 30:47
  Speaker 2: So that's another important aspect and I think, kind of when I came into that stage of my life, I started thinking about it a lot more and I got the opportunity to start working with DCTs at the company I was at, and I then felt quite frustrated for a long time.
• 31:08
  Speaker 2: But the Sierra industry wasn't and the farm industry wasn't engaged enough.
• 31:18
  Speaker 2: They were just not rolling with it.
• 31:21
  Speaker 2: It was just too slow.
• 31:22
  Speaker 2: Like the banks have gone digital, the insurance companies have gone digital.
• 31:27
  Speaker 2: Like the most stale and boring industries in the world have gone digital and we're still struggling right.
• 31:35
  Speaker 2: And finally, you know we started having enough of you know a focus on it.
• 31:43
  Speaker 2: There was an opportunity for me to start working with it full time in a full time role, which was great.
• 31:49
  Speaker 2: And then this opportunity with Thread appeared and I really had to just jump on it and I haven't regretted it ever, because it really is a case of where I, even though I could work with it full time, I still felt that it wasn't fast enough, it wasn't moving faster, like there wasn't enough kind of hands on.
• 32:18
  Speaker 2: Let's get this stuff done.
• 32:19
  Speaker 2: Thread offered that opportunity.
• 32:24
  Speaker 2: You know it's an environment.
• 32:27
  Speaker 2: Well, it's a very, you know, innovative environment.
• 32:31
  Speaker 2: In the terms of that, we are really pushing ahead with what you can do within the frames of regulations in the DCT space.
• 32:41
  Speaker 2: You know we're pushing, you know we're pushing as far out as we can go because of this benefits to patients, this benefits to sponsors, this benefits to sites, and we're allowed to do it.
• 32:56
  Speaker 2: So why not?
• 32:57
  Speaker 2: Let's do it, let's be the brave ones that do it and try and convince the rest to follow along.
• 33:08
  Speaker 1: That's an interesting journey and I love that I can recognize that frustration of us being such an innovative industry when it comes to the biology and the chemistry side of things and us being so slow when it comes to technology adoption or even adoption of new ways of thinking, of new ways of organizing ourselves.
• 33:28
  Speaker 1: We're still stuck in the same way.
• 33:30
  Speaker 1: We've been running from studio companies for the past 200 years.
• 33:33
  Speaker 1: It's such an irony to me that we're at the forefront, very cutting edge in one side of the technology space and so far behind in others.
• 33:42
  Speaker 1: I would be curious to circle back to what you said about a female representation in clinical trials.
• 33:51
  Speaker 1: That's also a passion area of mine, but a first reaction to me was whoa?
• 33:57
  Speaker 1: Is that also the case in Sweden?
• 33:59
  Speaker 1: Because Sweden is known as one of the countries that has the most equal distribution among in households between men and women, as far as I know.
• 34:09
  Speaker 1: So do we still see that gap in Sweden for clinical trials that there are more men participating than women?
• 34:17
  Speaker 2: Oh, I actually don't know the answer to that because I haven't seen any recent numbers in terms of country specific participation in clinical trials overall.
• 34:26
  Speaker 2: So I can speak only for myself and I don't know if I would be able to participate in a traditional clinical trial if I was given the option.
• 34:37
  Speaker 2: It really depends totally on what condition I would have, and what other options there are, et cetera, but I would always what's the benefit for me.
• 34:50
  Speaker 2: So if a traditional clinical trial is the only option for me and it's really something that I have to choose, I will.
• 35:04
  Speaker 2: But I think, strictly speaking, if it was like a general trial for a condition that was quite mild, I don't know, say randomly pick like psoriasis.
• 35:18
  Speaker 2: If somebody said to me we'll send you the cream to your house.
• 35:21
  Speaker 2: You download this app, you take a photo once a week, you report all your data every day, you get notifications and reminders on your phone.
• 35:32
  Speaker 2: Would you like to participate?
• 35:35
  Speaker 2: Well, yeah, I would.
• 35:36
  Speaker 2: Why not?
• 35:38
  Speaker 2: Let's do it.
• 35:38
  Speaker 2: If they said to me you have to complete these four different paper diaries and come back to the hospital for half a day every two weeks or every month for two years.
• 35:54
  Speaker 2: That's the commitment.
• 35:56
  Speaker 2: I don't know if I'd be so happy to do that to be honest, because I just wouldn't have the time, I wouldn't have the luxury to prioritize that, and so I think you know, from my own perspective, I would always be happier to participate in a trial.
• 36:15
  Speaker 2: That makes it easy and convenient for me, because it's the convenience piece that is really important when you talk about a patient-centric approach.
• 36:22
  Speaker 2: It has to be convenient for the patient.
• 36:25
  Speaker 2: So there are clinical trials, many of them, I mean just even the oncology space, where you will never get out of the fact that you have to go to a clinic, you have to spend time on a site with a physician, but there is a lot of stuff within that trial that doesn't have to be on site Hours and hours saved from those patients' lives when they can spend time at home, where they are comfortable, with their families, doing what they need to do, what they want to do, where you can decentralize parts of those trials.
• 36:57
  Speaker 1: I would be curious if you would have any advice for patients or consumers how the individual can maybe request or demand more accessibility of clinical trials.
• 37:13
  Speaker 2: Yeah, I think that's an excellent question because that ties back to that whole encouragement of being an early adopter right.
• 37:20
  Speaker 2: And then the world isn't an ideal place in many ways.
• 37:25
  Speaker 2: So I think even if you went to your physician and said I would like a clinical trial, they might not even know of any.
• 37:31
  Speaker 2: They might not even be available.
• 37:33
  Speaker 2: They might not know what's happening in their hospital, in other departments or in the country or what's available as a trial.
• 37:42
  Speaker 2: So it's not always that straightforward, but I think people in general have a greater interest in their health today than ever.
• 37:53
  Speaker 2: So I think it should be just a natural question from any participant or patient that gets into a situation where they have to be treated for something, that they are curious and ask about the different treatments.
• 38:09
  Speaker 2: Now we also have to, I think, collaborate more particularly the pharma companies and biotechs with their key opinion leaders to just kind of spread the word right.
• 38:20
  Speaker 2: So if you don't have patients that are active, which are not actively asking the question of clinical trials which I think is going to be the case in most cases, to be fair, that's probably what it's going to be is that they actively need to offer clinical trials, and so I know, particularly in Sweden that's a problem because our healthcare system just doesn't have enough resources to absorb all the clinical trials and it's a real struggle in the real life setting to take on clinical trials and being able to offer them.
• 39:00
  Speaker 2: But I think there's also a lot of work being done from a number of different patient organizations that, at a political level, are trying to influence governments to say, in terms of healthcare, we want x% of patients with wide condition to be offered clinical trials as a care option, for example.
• 39:22
  Speaker 2: So there's a lot of work being done in that space as well in some areas where they're trying to kind of lobby and influence that at a government level, which I think is great, because if a clinical trial is built into the healthcare system it's going to offer more patients the opportunity of actually trying some of the cool new stuff that's being invented out there.
• 39:54
  Speaker 1: I would also be curious to know if you've seen some sort of trend in the kinds of indications that a threat is mostly being used for.
• 40:07
  Speaker 2: I wouldn't say mostly, so not necessarily threat, but I think this is just the way of the state of DCT and the industry at the moment is that DCT is considered in many cases for rare diseases, for example, where it might be difficult to travel for patients, but also because they kind of spread out across the world and there's often quite a few cases.
• 40:33
  Speaker 2: So it's not like your traditional cardiovascular trial that you can get 1000 patients in one city and one university hospital, but you kind of have to have a different strategy to actually get enough patients and get enough data.
• 40:48
  Speaker 2: So, for sure, threat is being utilized in rare disease trials, but also in trials with a lot of patients, like when you wanna have real world data and you need thousands of patients.
• 41:02
  Speaker 2: It's a huge operation trying to even get that to be done in the traditional setting with 50 sites, 20 sites, 100 sites and thousands and thousands of patients, you can have one site per country and still get the same amount of patients in a very short space of time and have thousands of patients using our app and the threat solution feeding all that data straight back to the pharma companies.
• 41:31
  Speaker 2: So there's really no limitation at all on how the threat solution can be used.
• 41:43
  Speaker 1: And is there a next evolution of threat or the next big aspiration for where the platform is going to go?
• 41:51
  Speaker 2: So I think we already have a very strong foundation, a very well thought through solution, but, of course, we always want to strive for excellence and be available for everyone everywhere, and there's new challenges all the time and there's things we can also do better, and I think one of our main offerings is around the eco appease and especially, especially ePROs and patient reported outcomes, and so our focus is really to make that offering best in class with things like advanced scoring, for example.
• 42:38
  Speaker 2: That's not available everywhere but is a threat.
• 42:43
  Speaker 2: So I think our eco offering is extremely sophisticated, which is just so valuable to our customers, because when they look at what digital endpoints and their endpoint strategy, what they're gonna choose for their program and protocol, and the fact that the threat solution can support that in terms of collecting that data, scoring it where needed, that type of functionality is something we're really, really proud of.
• 43:22
  Speaker 1: Well, that'll be interesting to follow the evolution of that.
• 43:25
  Speaker 1: As we start rounding off, we always ask our guests the same final question on the show, and that is if we gave you a magic wand and you could make one wish, that would change something in the life sciences industry.
• 43:39
  Speaker 1: What would you wish for?
• 43:42
  Speaker 2: I think we already covered it today, but I would like to wish for the decision makers within the pharma and biotech companies to be braver, really to be braver and adopt DCT strategies into their core clinical operations thinking and into their core business when developing protocols, and just be brave.
• 44:17
  Speaker 1: Well, I can definitely be on board with that wish If our listeners have any follow-up questions for you.
• 44:24
  Speaker 1: I want to learn more about threat.
• 44:26
  Speaker 1: Where can they find you?
• 44:28
  Speaker 2: They can find me on LinkedIn.
• 44:29
  Speaker 2: I'm available there.
• 44:32
  Speaker 2: They can just reach out.
• 44:34
  Speaker 2: I'll be happy to chat to people about this.
• 44:39
  Speaker 1: Awesome.
• 44:39
  Speaker 1: Well, Eva, thank you so much for coming on the show.
• 44:41
  Speaker 1: This was a pleasure.
• 44:43
  Speaker 2: It was my pleasure, Ivana.
• 44:49
  Speaker 1: MUSIC.
• 44:49
  Speaker 1: You're listening to Transformation in Trials.
• 44:53
  Speaker 1: If you have a suggestion for a guest for our show, reach out to Sam Parnell or Ivana Rosendal on LinkedIn.
• 45:00
  Speaker 1: You can find more episodes on Apple Podcasts, spotify, google Podcasts or in any other player.
• 45:07
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