Enabling Clinical Trial Technology that Cuts Risk and Speeds Patient Access

Clinical trials are meant to generate evidence, not paperwork, but too many studies still depend on spreadsheets, duplicate data entry and unconnected systems. This episode we are joined by Karen Maduschke, a clinical trial technology leader with over 20 years of experience, from building one of the first interactive e-consent products to scaling trial tech through acquisition and entry into a global CRO environment. 

Together we explore one of most pressing challenges in Clinical Trials: moving faster without sacrificing integrity. Karen breaks down why “speed” is really a workflow problem, how poor integration creates site burden and error risk, and where new technologies and automation can genuinely help. We also talk about what must come alongside that shift: validation, information security, patient privacy and clear governance to protect patients and control risk. 

The episode also touches on practical tips if you are a founder selling into pharma R&D. We map the different corporate players you need to get on board and to buy into your product, not simply your technology - from clinical operations and procurement, to QA, legal, IT and information security. We also explain why pharma does not buy shiny tech, but reduced risk and faster delivery. 

FInally we finish with our ever fun game show round focused this episode on "How couch was this trial?" exploring the extent to which decentralisation in trials is becoming a reality? Subscribe for more, share this with a founder or trial leader who needs it, and leave us a review with your biggest barrier to a faster, cleaner transition from Labs to Lives.

Visit Labtolives.com

Do you want to try the quiz from this episode? Find the link on our LinkedIn profile: https://www.linkedin.com/company/labtolives/ 

Would you like to join the show as a guest or collaborator? Find out how on our website: https://www.labtolives.com/ 

Transcript

Copy Transcript Copied

Welcome And Guest Introduction

Speaker 1 0:37

Hello everybody and welcome to another episode of Lab to Lives. Now, the observant among you will have already noticed that Ivanna's voice has changed somewhat. That's because it's not Ivanna's voice, it's me, Alex, leading the episode today. Ivanna is out having a US adventure, and Dimitri is also taking care of a few bits and pieces that he needs to. But to replace their absence, we have a absolutely fantastic guest here today in the form of Karen Maduschke. Karen, how are you doing?

Speaker 1:09

Doing wonderful. Thank you, Alex. Really glad to be here today.

Speaker 1 1:12

Yeah, no, we're incredibly happy to have you here. Uh for our listeners, then, would you just like to give a brief introduction to yourself and you and your history? I'm very excited by some of the things you've done in the past, world firsts and all of that. So, yeah, how about a brief introduction just to get everyone on board with who you are?

Speaker 1:27

Sure, I'd love to. Thanks so much. And again, thanks for having me today. So yeah, Karen Maduschke. I was formerly, most recently with IQVIA, and currently I with Clin Tech Strategy Partners. That's a consultancy that I'm running since I've left IQVIA. And my background is mostly around clinical trials technology. So we started more than 20 years ago when we developed the first e-consent, interactive e-consent, to be used in clinical trials. We started that with a tiny little startup in Frederick, Maryland called Enforme Interactive, sold that eConsent product eventually to Drug Dev, which was then acquired by IQVIA. So I've had the great pleasure of sitting in a highly dynamic, innovative little tech startup company at the time US-based, in fact, going through sort of a midlife growth phase and acquisition into a somewhat larger but still relatively small company, and then being acquired by obviously one of the world's largest CROs, IQVIA, and running the technology from that perspective inside of IQVIA. So that's a little bit about the journey. I now take that journey and I share the insights I've learned over more than 20 years with startup founders in technology who are trying to break into the pharma R&D market.

Speaker 1 2:44

Amazing. And actually a rare breadth of experience, I think, to go from you know little startup to dealing with someone as large as IQVIA are these days. They're doing very well. So I will bring you then to our first question that we ask all of our guests, although maybe maybe you've got a long answer to this one, which is we have a thesis here, which is that there's five main pillars to pharma and medical devices, five streams. There's

Mapping Innovation And Compliance Together

Speaker 1 3:10

the innovation stream, there is the production slash manufacturing stream, there's the compliance stream, there's the commercial stream, and there's the corporate stream. So we like to ask people to place themselves in these streams to give people a grounding in where they are. So do any of those jump out at you, Karen?

Speaker 3:27

Absolutely. So first of all, uh about that model, I love it, that it covers sort of a bird's eye view of the end-to-end process of drug development. And, you know, at that level, I'd say squarely within the innovation area, um, working in clinical trial technology. But one of the things I think is really important to do, and that I think many people would relate to, is kind of zoom in from that bird's eye view, and you'll find almost a bit of a microcosm of all of those within each stream. And so I have a very strong compliance and regulatory bend, but that's within the innovation stream. A lot of concern about things like patient privacy and data integrity that are governed by regulatory and quality. So, you know, your stream has a compliance and regulatory bucket, but that tends to be post-drug approval. And I'm still in the pre-drug approval phase of that. So that's where I'd say there's a bit of overlap and also to some extent commercialization, because one of the things I'm doing right now extensively is helping founders and startup companies learn how to scale and commercialize their business, but again, within that innovation stream.

Speaker 1 4:42

Yeah, it's a really interesting point you raised there, actually. And uh it made me think that there's maybe some recursiveness to this model. Or I don't know, I I started thinking of fractals then, right? Each each each pillar contains within it the completeness of the other pillars as well. They're not fully separable, but there's different emphasis. To a large extent. Yeah, I agree. Super. Well, we're not here simply to talk about fractals today and things like that. We are here to explore your experience and expertise and help support, frankly, in how we can help get innovative drugs, devices, diagnostics through this challenging process from the laboratory to patients' hands and an impact in their lives. So what we tend to do next then is ask, do you have a big core either challenge that you see that needs to be overcome in that or or a core thesis as to how to do this better as a launching point to the conversation today?

Speaker 5:37

Although

Speed Versus Risk In Clinical Trials

Speaker 5:37

I don't think it's very unique, I think there's widespread agreement across the industry that we need to do things faster and we need to be able to do them faster without sacrificing integrity. In fact, I think a lot of us agree that we could have better data integrity, better data cleanliness, and that's part of what will get drugs to market faster and thus to patients to help improve or prolong their lives. So I think, you know, it's constantly this dynamic between speed and risk that we're trying to address. Well, secondary wouldn't be the fair thing to say, but obviously inclusiveness of patients that's a second prong that we need to address. So we need to be able to get through trials faster. We need to do it better, and doing it better includes, you know, having more patients involved and the right patients involved and making sure that they're well served through the clinical trial process.

Speaker 1 6:31

No, amazing. And I could certainly agree. I've I've definitely uh heard that that point made and I'm fully on board with that as well, right? The the clinical trial piece is is often the biggest and most expensive. It does raise an interesting secondary question then, which is if we have this large agreement of the need to go faster and uh faster without sacrificing quality. What for you stands in the way of that currently? What are what are the barriers that we need to overcome or start breaking down to be able to do that?

Speaker 7:02

Oh,

Broken Workflows And The Integration Gap

Speaker 7:02

certainly it has to do with so much manual process that we've been using for so, so long. Spreadsheet hell, any any clinical study coordinator, any site will tell you about that. It's the the various technologies that aren't working collaboratively, that aren't integrated to the extent that they need to be to streamline the workflows for sites, for patients. So those are some of the biggest barriers that we see. If sites are struggling with the software that they're using, with the technology that they're using, if patients are struggling with those, that's you know, introduces so much room for error. The transcription of data that's been captured in one system into another system, the cleaning of it, the merging of that data from one site with the thousands of others that might be participating in the trial, the analysis of that data, identifying outliers, identifying safety flags. So all of, you know, our workflows are broken. They're cumbersome. We need to fix that. And we are standing at a point, I think, in time, where we've got the greatest potential we've ever seen with the introduction of new technologies, with artificial intelligence, with machine learning, with workflow automations to fix some of these very core problems that we've had for decades. Get so much unknown around it. How are we validating it? How are we making sure that, you know, that it's the models work appropriately, that there's no hallucinations, that data privacy is protected. You know, we raise a whole slew of additional questions in solving the problems, but I think right now the potential far outweighs any of the challenges that we're facing. It's very exciting.

Speaker 1 8:47

Hugely exciting. Well, and I think what strikes me about that process that that I quite like is I'm always reminded in discussions of how do we speed things up, there's there's always the the the famous triangle, right? The the what does it cost, quality and and and speed. And then and the famous line is you can have two out of three, but but not all three. But it sounds like what you're talking about then is looking at, well, maybe that's not entirely true. Maybe if we're focused on a process improvement orientation around this, we can we can click all three of those uh elements.

Speaker 9:21

Yeah, I think you're absolutely right. Maybe we maybe we turn that triangle to a circle and you know, have everything on the circle evenly, even. But uh yeah, I think there is tremendous potential to make it possible to have all three. Absolutely.

Speaker 1 9:35

No, great. So is this a topic that you think is it being picked up? To what extent is it being picked up right now? Are you seeing people really get to grips with this problem, or are we still in this murky early stage of solving it?

Speaker 9:49

That's

Where AI Helps And Where It Scares

Speaker 9:49

a great question. And I'd say it almost depends on where you're. I think globally that there's still a lot of differences about how we're approaching this and perhaps even in what area of research you're working in. So if we think, of course, the the behemoth of clinical research being US-driven major pharmaceutical companies, they're absolutely all over this. They're working with major CROs as well, and uh and internally within sponsored organizations to tackle these problems, to identify innovation, to support innovation, whether it's buyer build or some hybrid combination of that. That's true. If you're looking, I think, uh outside the US, uh, there's still a lot more hesitancy. Uh, there's still uh greater concerns around, you know, is this all it's cracked up to be? What's behind the black curtain? A little bit of, you know, Oz and the wizard back there that uh it can't be trusted. And, you know, that's that's good. I think we need that perspective and we need those breaks to be applied to some extent to make sure that we are doing things carefully and accurately. And then I think also if we're looking at a lot of the research that's conducted at an academic space that isn't necessarily driven by the large pharma's, um, that's also a very different lens that's being looked at. And again, perhaps largely a little bit more cautious. But I'm also encouraged by all of the incubator programs that I see out there. I work, for instance, closely with Day One in Basel. There's quite a number of them out of Berlin, here in Germany, where I'm based, and incubators, of course, all over the United States that are, you know, setting up a platform for these startups who are willing to tackle these problems and who can be more agile than the large organizations. And they're supporting them, they're encouraging them, they're mentoring them. In some cases, they're then partnering, in other cases, they're acquiring uh these startups. But I've worked with over the last two years now some really brilliant young people. They're not all categorically young, but they're all younger than I am. No, sure, yeah. Well, that flips in life, right?

Speaker 1 12:03

Uh yeah.

Speaker 12:04

But they're um, they're really, really, really smart and they're really brave and they're willing to tackle problems. And I'm seeing a lot of partnerships amongst these young entrepreneurs of people outside the clinical trial space who are just, let's say, engineers and data scientists who then through various relationships come into contact with people who are in the pharma and drug development space. And they bond over these issues that one can solve for the other, and they build partnerships where somebody with the real engineering expertise that is needed is working closely with somebody with the real clinical trial operative experience in order to have the right lens. And they're doing some really cool things, and they're doing it in patient recruitment, they're doing it in data cleaning and data monitoring, they're doing it in patient education and decentralized trial technology. So there's a lot of great work happening out there, and I love watching it, and I love the opportunity to mentor some of these folks and coach them on their way into the world of pharma.

Speaker 1 13:15

That's super exciting. It it also sounds familiar to me in a sense of I don't work on the the the innovation in clinical trial approaches, but obviously I do a lot of device stuff, which is similarly, you have a lot of quite often young, exciting, dynamic startups doing something new in the space, often because they're unburdened by the conventions that have grown up in the industry. So right. And uh we've got this behemoth of the oil tanker of the of the large pharma companies, and then you know the startups in their little speed boats sipping around. But I mean that strikes me as a as a bit of a challenge because then you are in this little speedboat trying to trying to cause this huge tanker to to turn. And even if it knows that it needs to turn, quite often they don't have the ability because they've grown up career-wise in this way of working, this way of operating that isn't so easy to change. So,

Startups Versus Big Pharma Adoption Reality

Speaker 1 14:08

two-part question then. Is this something that you see in this area of work? And if it is, what sort of things do the little guys in the speedboats need to be doing to try and best influence this oil tanker?

Speaker 14:22

Well, you know, that again, that's another great question. Absolutely, that's what's happening. I think it's happening in two different ways. So we've got the oil tanker to some extent saying, hey, you know, maybe it's not an oil tanker, maybe it's a big fishing vessel, right? And they're trying to fish. And maybe what they can do from their massive hull so far away from the surface of the water is, you know, not as good as what the little speed boats can do. And so to some extent, they're outsourcing the pieces of the fishing that they can do. You know, let's give us these nets and these rods to the various speed boats. Let's utilize a bunch of different speed boats, but let's make sure that they've all got an excellent communication system and can talk to each other so we know who's doing what. So I think that's one of the ways, if you will, that the sort of the mothership is learning how to be more agile, is leaning on taking things sort of outside of their very cumbersome processes. Sometimes I've seen large pharma players do this by having like an office of innovation that's got a little bit more runway and a little bit of budget where they can experiment, if you will, with these more agile organizations. But sometimes I think it's really the agile organizations figuring out that, you know, there's some way for me to throw a tow line to this boat and to use my speed and turning angle to pull it along with me. And some of that's happening as well. But we need both models, right? But to how do we make it successful in concrete terms? I think, you know, these speed boats, these young, dynamic, smart, and courageous innovators, they do need to understand better what the constraints of big pharma are in order to help even big pharma address those and in order to gain credibility with big pharma.

The Buyer Panel And Ecosystem Fit

Speaker 16:09

So this is one of the things, you know, and this goes back to what first Ivana and I bonded over, is she was able to put out an article some time ago that talked about how pharma buys tech and how you know engage these vendors. And she says they, you know, they do a lot of window shopping sometimes and they bring them in and they get presentations, but there isn't necessarily the intent to move forward. They just sort of want to understand what's out there and understand the market. And, you know, from the other side of that table, I've been advising these young and dynamic organizations about how to approach these large pharmas. And frequently what'll happen is that these organizations will know who they can help best. So let's say they believe that their technology is going to help a site user and it's going to make life for a site user a whole lot better. They may even find sites that agree and are wholly on board with it and think this technology looks really good. They know somebody who works at a site, they've worked with them, and they now have sort of a leg in the door with a farmer that might want to buy this technology to deploy across sites. And they go in with their sales pitch about why this is so fantastic for sites, but they're not expecting the 10 other people who are going to be sitting at the bid defense table. They've put their bid in, they've put their proposal in, and now they show up and suddenly it's not just the patient advocacy and the site advocacy organization that's sitting there. It's folks from clinical operations, it's folks from procurement, it's regulatory affairs, it's quality assurance, it's a legal team, IT, information security, data managers, all of these other players, they have a stake in how this technology operates at the site level, how it integrates within their uh clinical trial technology ecosystem. You know, how does it work with EDC, with the CTMS, with the ETMF, and where is the data stored? Is it in the cloud? Is it on-prem? How is it anonymized? All of these other questions come at them. And so it's really, really important that founders understand this buyer panel that they might be going against and that they have all of their assets sort of lined up in advance. Understand what the pain points of each of those players is so that they can start to address them.

Speaker 1 18:42

Yeah, what nicely comes out of that for me is it sounds like really a classic adoption challenge/slash approach, which feels very familiar in the sense of there's a catchphrase that that we have at my company, which is great science doesn't sell itself. And what we mean by that is is kind of what you're describing here. You you can identify a very technology-driven need and a very technology-driven solution, and uh that fit might be exact. And I think we see startups come to big companies and expect that to be the only piece that matters, right? The need is there, the technology is there, the two fit together. Give us $10 million, please, and uh we'll we'll be on our way. But I think what you're describing and what we see is it's it's not quite like that.

Speaker 19:26

Not at all. No, no, no, that's really a a perfect analogy. And one of the things I've said is that you know, pharma doesn't buy shiny tech, they don't buy the technology for the sake of technology. They want to reduce risk, they want to speed to market. And those things have to play into the whole scenario. So it's always really, really critical that a founder, any solution, understands the ecosystem in which it's working. And that's, you know, for me, that's like all of the clinical trial technologies. One of the documents that I put together first when I started consulting was just called the clinical trial technology ecosystem primer set. And so here, these are all the different phases of development, these are all of the different systems that are being used already. These are the things that your system needs to fit in with smoothly. And it's amazing to me how many people will develop a solution and not understand that whole ecosystem, you know, the most basic other pieces and why, if you're going to put this solution in place, it's really, really important that it does speak to, again, depending on the nature of the specific solution, the EDC or the trial master file, the ETMF, or, you know, the the CTMS system, the clinical trial masters system. So it needs to founders need to understand where they sit, not just the problem they're solving, but where that problem fits with everything else and what potential risks that might create.

Speaker 1 20:56

No, amazing. And we know from experience, founders tend to come from this technical direction, right? They find a need and they develop a solution. And quite often the intricacies, the complexity of this healthcare space is completely new to them. So,

Pharma Readiness Advice For Founders

Speaker 1 21:11

you with your experience of this, what advice do you have then to a founder that's maybe listening to this and sitting in that position and suddenly realizing, oh, there's this whole world that I don't understand and need to to effectively sell? You know, where do I begin?

Speaker 21:25

Well, without advertising my services. There's there's certainly plenty of opportunities I mentioned earlier with all of these innovation programs, incubator systems that they can apply for. And I would do a quick search on what's out there for pharma readiness assessments that will help you walk through a checklist of what you might need to know that will help you assess where you're at in your development stage, in your asset stage, and your ability to meet the different stakeholders. There are certainly plenty of resources out there and programs that will help you identify these things and help you develop what it is that you need. Make sure that you've got your SOPs in place and that you've got your validation packages in place. So seek out some expert advice, I guess I'd say.

Speaker 1 22:10

No, I that's great. Yeah, I think it's so often the the answer in this space is seek out the expert advice. I wonder also about the provision of that advice in the sense of we've got these big pharma companies that also need this, right? They they need these innovative approaches to clinical trial management to come through and to be usable. And maybe there's something on their side in terms of communicating better outwards what they need to see. I know we talk about the window shopping and I I because I also say this from experience is that having been in that room with Big Pharma, it's often not very explicit actually what what what they need to see. And you sort of have to read between the lines and and things. So I don't know about your experience, but d do you find that do you do you see there's a need to to lay this out more from the farmer side or or I don't know. How does that look to you?

Speaker 23:03

Yeah, I think that's a great point too. You're absolutely right. And I think that's a byproduct of how large some of these companies have gotten and how silent they are. I think sometimes when you're looking at large pharma, the right hand doesn't know what the left hand needs, you know, internally. I've seen great examples of pharma companies that, you know, again, as I say, might have an office of innovation that sits across different parts of the business. And even going back to your model across the different parts of the work stream, right? Because you've got to have a view for not only how is this going to impact at the innovation stage, what's going to happen when we get to regulatory and quality compliance and ongoing pharmacovigilance. And some farmer companies have done a great job with this. I'm not going to name names or anything, but that really do centralize some function that is able to strategically look across what their organization needs and to identify those problems and to be out there then proactively sourcing solutions. Again, often with their um partnerships, either they've got their own AP data programs or they're supporting and sponsoring other ones. But then I think there's unfortunately some large pharma that still struggle with that internally. They don't have an internal solution. And so folks sitting in one side of the business that have a problem to solve, they may be very keen on you know what we talked about for before you know scientists, engineers got a solution to a problem and it meets that particular need. But that individual even within pharma hasn't got the connections within their own organization. And I've seen this I've seen it in pharma I've seen it in large CROs I don't think there's an easy answer to this question. If there was we'd all solved it a long time ago.

Speaker 1 24:40

No, no, exactly. No, it's an ongoing challenge to be solved, which is also the point of this discussion. It reminds me also of of there's also understanding all of these different viewpoints but there's also the element of understanding who it is that has the real positive and negative power, right? Quite often we talk about key opinion leaders and that's that's a positive power situation. Someone can recommend you and and give you that boost in in terms of adoption. But then there's also the negative power side and and we see this again a lot in devices where you can spend ages developing a device and get it made and and approved and and on to market and then it gets into a hospital and it doesn't fit with the existing clinical procedures, clinical practices in that hospital. And so healthcare practitioners in that situation simply don't use it. And that's I I don't mean this in a judgmental way but that's kind of a negative power, right?

Speaker 25:34

It absolutely is. I mean we saw this with eConsent as well it was the same you know pharma would love it, sponsors would love it, CROs, monitors would love it. And if the sites couldn't figure out you know where to charge the iPads overnight or you know how to you know how to log into something or get on the Wi-Fi or whatever, if there was some barrier at the site level, it didn't get adopted, it didn't get used. And that had real consequences particularly if that was integrated into their other systems and a required step that had to be done and then it caused frustration.

Advisory Boards And Network Effects

Speaker 26:07

Back to that whole expert opinion you know I I think the other thing that I I should have raised is I've always said to these startups that I work with make sure you've got an advisory board. Put together the diverse stakeholders that will be able to kind of give you guidance do you need patients? Do you need study coordinators? Do you need somebody from operations? And you don't need to ask you know for a ton of their time you may not be able to give them some sort of equity or payment for it. But you know find some way to pull in advice in an advisory capacity if it's you know a quarterly meeting for an hour where you say this is one of the things we're looking at what might we be missing you know what other pieces of the puzzle have we not addressed and make sure that you're utilizing an advisory board.

Speaker 1 26:57

Yeah that's great advice. I mean because there are I a lot of people out there that are willing to give that little bit of time whatever it is an hour a month or and there's there's also networks for that. I know there's some around here and universities tend to have this or or incubators tend to have this. But there's also reaching out to people actually contact of hey I saw that you're in this role and and I think you'd have valuable advice for us. Would you like to spend some time as an advisor is also a a legitimate way through this as well I think.

Speaker 27:24

I've had three phone calls you know just in the last month from people who found me on LinkedIn and wanted to spend three minutes, you know, saying it sounds like you might know something about this. Can we ask you some questions? And I'll tell you what, I'll give any 30 minutes of my time that I can carve out especially these you know I should be careful saying this out loud on a podcast but you know I I I I get a lot of energy at this stage in my career out of seeing people succeed and bring you know cool ideas to market. And if my asking questions and poking holes for them for 30 minutes gives them something to work off of and to move forward with, then you know I'm happy to be able to do that. It's a nice way for me, you know, at my ripe age to give back a little bit more to the industry.

Speaker 1 28:08

No I that also raises, I think, which is another useful point going back to our to our oil tanker and speedboat metaphor which is maybe that's part of the answer is is trying as little as possible to be one you know company on your own, but to be more networked to more of a community built around this idea via your advisors or via key opinion leaders in in clinical practice or via just interested people you can help and have some expertise. And so it's not one boat on its own trying to move this tanker but a bit of a network of them who who have different ways in and different different influences. Yeah absolutely yeah well that's great. Do you see people starting to to recognize this to build these networks within this space or or is this also kind of a new thing that's that's emerging in in the experience and connection you have?

Speaker 28:55

Yeah I know absolutely I mean I do see networks being built all over but I'm not sure that that's new. I think most people have recognized for a long time I think perhaps it's getting easier to build networks though. I think you know we say this all the time the world is getting smaller. We have so many more methods of communication so many more ways to get together again. And certainly since we've made it through the pandemic people are eager to get back out to go to conferences to go to presentations you know just at at the Global Health Tech Summit in Basel last March just so amazing seeing all of the brilliant people coming together and sharing ideas on all of the different presentations on stage and they had fantastic networking opportunities and that's the kind of event too that I think is really important for startups to get out and to get into too there's there's you know very very low cost ways to be able to get your product into a booth and to talk to people and meet folks. I met quite a number of people at the Health Tech Global Summit as well that I was able to follow up with amazing no I've also been there once in the past and it was it was pretty good.

Speaker 1 30:01

Basel's always a very nice city for uh doing uh life science stuff in as well it brings me on to another thought actually because we've talked a lot so far about the the you know the big developers and the and the and the small developers and how they can work together.

Regulators Harmonisation And Data Security

Speaker 1 30:16

Do you see a role in helping this transition for say regulators and and and health authorities? One thing that's particularly my mind when I say that is I know that again on the medical device side there's been a real effort for harmonization across jurisdictions around you know the the regulations. Is that a similar problem? Are there different regulations for different jurisdictions that are complicating this or or how does that part of the equation look?

Speaker 30:45

There are and to some extent there probably always will be but I do like you like you're seeing with MedTech absolutely a tremendous amount of harmonization. We see that even with AI and we see the FDA and the EMA working together and putting out joint guidelines. Love to see more happening with Japan's PMDA working also with the EMA we've got regulatory authorities really across the globe all look at things um through their own unique lenses and based on their own experiences with data breaches or issues that they've had, safety issues that may have arisen. But I think the extent to which global regulators do communicate and you know they all have at heart the same exact concerns. They care about patient safety and patient data privacy. You know the reason that we're all in the pharmaceutical industry is because we want to help patients. And that core binds all of us more than any individual law separates us. And so there is a lot of effort at harmonization and there's more potential for furtherized harmonization regulatory. But I'm very much encouraged by how much I'm at least seeing between you know North America and Europe, for instance and UK to work together on bringing guidelines. And then we've got organizations like Turncelerate I think do a lot of great work from a global perspective as well and trying to harmonize guidelines and advice and not just regulatory but to some extent influencing regulatory as well.

Speaker 1 32:13

Oh great to hear that's also going on in that in that area. I mean outside of the harmonization element are there also ways that you see that that that the the health authorities or the regulators could could further support this process or or is it about just breaking down those barriers?

Speaker 32:30

Yeah I think it's probably you know continuing just to work together and to try to you know but there's so many parts the regulators also aren't working in a vacuum right so you know I again I come at things very much from a data perspective where's the data live how's the data managed and I think that you know we've unfortunately seen massive data breaches you know and there are some legitimate concerns there. You need IT security people and regulators to be able to work together and find solutions and figure out what is an acceptable level of risk. There's always going to be risk unfortunately because there's just you know there's bad players out there who are are trying to you know as quickly as we develop new security protocols, they're finding ways to break down those security protocols. And I think you know that's that's what it drives and it's it's people's appetite for risk. I said earlier I think you know the US is perhaps a little less risk averse than Europe is and Europe is probably less risk averse than parts of Asia Pac are so what's the right balance there? And I'm you know I don't know I don't know what the answer to that question is but you know certainly the way to get to an answer is to keep communicating and coming together.

Speaker 1 33:46

Yeah when I I risk is always one of those things it's it's hard to proactively work out what the best answer was. Reactive is very easy right a breach shut it all down. Yeah yeah exactly that becomes very obvious. Yeah

Game Round How Couch Is This Trial

Speaker 1 34:01

no uh fantastic I think that's a very nice uh exploration of the topic so time to move on to our fun section of the uh podcast which is our well-loved deeply appreciated uh game show round are you gonna play the Jeopardy music first I think we need a Jeopardy introduction you know what I would love to play the Jeopardy music I do not have built that built into this control panel here maybe that's what we need to do for next time Ivana has very nicely kindly produced a quiz for us this week with the fantastic title of How Couch is this trial how how couch as in sofa as in sofa yeah yeah yeah it probably also needs a translation for the for the water going on exactly how sofa is this trial this trial is inspired by the fact that we're seeing so many more trials become decentralized and and have this proportion of patients at home which makes them much better and more accessible. So we have a series of questions we have to guess how couch was this trial. Karen are you ready? I don't know that I could ever be ready but let's let's go for it. Well we're both equally unready I have the questions I don't have the answers until I put something in so we'll both be tackling this together as a team. So question one the adaptable aspirin dosing a patient-centric trial assessing benefits and long-term effectiveness study what an amazing acronym to start off with was a large-scale pragmatic trial published in 2021 that compared two daily aspirin doses 81 milligram and 325 milligram in patients with established eferosclerotic cardiovascular disease this was 15,000 participants and the team identified patients by looking at electronic health records the key question though is how couch was this trial? Was it a 100% couch no participants had to go to the site B 50% couch patients had to go for every second visit or C 0% couch the patients had to go to the site for everything.

Speaker 36:07

Initial thoughts Karen any clues jump out at you from that I'm thinking this is one where patients can put their jammies on and grab a mug of tea and make themselves really comfy on that couch. When I listen to you know data it's being collected from an electronic medical records and you know take an aspirin this is not uh we don't need uh IVs I don't see any reason to be on site I would really like to hope that the answer is a 100% I think that's also a great answer.

Speaker 1 36:38

I am I am going to be the slight naysayer 2021 jumps out at me I'm trying to imagine in my head where we are on that on that curve. So maybe we haven't quite got there by 2021 although 2021 was also pandemic time so maybe that's a red herring. I'm gonna say 50% though and let's see who is right. In fact you are 100% right Karen it was 100% couch that particular study. Get my fluffy socks yeah exactly I was led astray by uh by Ivana's 2021 reference there I'll have to uh get my revenge somehow in a later quiz. Question two Pfizer's remote virtual experience trial testing detrol, which is tolterodine four milligrams for an overactive bladder uh this was in 2011 with 456 patients participants passing the initial screening but the key question that we want to know is was this trial 100% couch 50% couch or 0% couch what do you feel on this one Karen?

Speaker 37:41

Well Pfizer was a client in 2011 also you've got insight here like channels this is where this is where a network helps right uh but but that being said while they were certainly at the forefront of innovation on DCTs I'll give them a lot of credit for that. I'm still gonna say that small study group can't say that that was a specific trial we worked on. Don't think so. So but just you know as an organization they were certainly trying to work into that direction but we're still on A B C 150 zero is that the we are indeed now it's definitely not A. It's gonna be between B and C. Was this one of their attempts to do things a bit decentralized? I'm gonna say no. I'm gonna say C.

Speaker 1 38:30

This was 100% on okay yeah I think I'll also say the same I mean it seems like uh the type of trial that could be run at home I just worry that 2011 is is a little bit early for it to be hugely at home. But uh let's see we are both going for C0% and the answer is once once again 100% couch.

Speaker 38:51

Wow okay I just we have asked two questions what was the administration of the uh interventional products and what were the key endpoints but uh without that data yeah okay a hundred well I mean I would have also not been able to answer either of those questions because I do not have that information in front of me but uh no I mean well done all couch I'm impressed Pfizer exactly I think a point to Pfizer in this in this competition actually for for being so far ahead of the curve so it's Karen won Pfizer won me zero so far.

Speaker 1 39:26

Question number three ultimate question for the win this is a Pfizer and Biotech COVID vaccine study in 2020 may also be a clue. It was 43,000 participants and used decentralized elements and it was a study to learn if RNA vaccines are safe and can prevent COVID 19 in healthy participants. We have the same three options do we think it's a 100% couch B 50% couch or C 0% couch what year?

Speaker 39:55

2020 2020 2020 I was certainly at home in my sleepers vaccine well the question is the administration of the vaccine all the follow-up data could have been collected remotely but the initial administration of the vaccine if done on site and the screening test done on site does that make it 50%? I'm gonna go with 50% just because I don't think those things in 2020 were being done remotely.

Speaker 1 40:27

Yeah it's it's interesting I mean I guess I would guess that the yeah I mean I guess that the administration at least would be parental right but I I'm gonna take the plunge I'm gonna go 100% couch. It's been right so far it could be right again. 2020 I was certainly on my couch for the vast majority of it. Let's see what the true answer is it was 50% couch. So excellent work there Karen so that gives a total score of two points for Karen one point for Pfizer and me languishing on zero once again for this week I'll go and uh the med tech you know handicapped that wasn't fair yeah it is it is often described as a handicap yeah yeah definitely no well I I can certainly now take to my own couch and and mourn my loss and that's maybe my plan for the rest of the day. No thank you for that Karen and I hope if you uh listeners at home would like to take that quiz yourself uh it is on our website there's links to it please test your friends see if they can outperform Karen or Pfizer Karen uh that leaves us really just to sum up what we like to do is to have each person come up with a a sentence or or a key discovery thought from the episode that they think is uh yeah an important point for listeners to take away.

Key Takeaways And How To Connect

Speaker 1 41:45

Do you uh do you have one or would you like me to start? Ooh I'll I'll go ahead gentlemen first. Let me go first. No well what I uh took away from this is the need even in this space to apply your customer understanding and sort of active adoption processes to to this I mean of course we all know we need to do this if we're gonna have the end customers buy something and and Lord knows that's a that's a complicated space, right? We've got payers, we've got providers, we've got, you know, the health systems themselves we've got all these different actors but even this intermediary step of of selling our technology or having it to be used by big pharma in clinical trials, you know, requires that as well. And so that's that's a key takeaway for for me.

Speaker 42:32

Yeah I think if I were going to add to that I would just say you know continue to be brave and bold continue to pursue the big problems. I always want to encourage founders you know I one sort of aside we didn't get to a bit is you know I I'll have people come in and say yeah the space is getting really crowded. There's a lot being done in this area there's a lot of competition already. You do under need to understand the competition understand the market understand their stakeholders but also recognize that at any given time there are tens, thousands of clinical trials going on in the world. It's a huge marketplace huge and so just because there are some you know good strong players out there it doesn't mean you're not going to find your market niche. Network, you know keep solving the problems network find your find your in-road get your advisory board together talk to your experts go to the conferences don't give up you know just we need people to continue to innovate and to be courageous.

Speaker 1 43:28

And yeah I want to just encourage people to keep doing the yeah don't give up be courageous keep going that's uh that's amazing yeah I fully endorse all of that as well. Okay great well we're coming to the end there. One last thing Karen if people want to talk more on this topic with you how can they find you?

Speaker 43:45

Fantastic. Certainly they can find me on my website ClinTech Strategy email and contact and schedule a call links are all there and some of the resources and blogs that I've put out that might be helpful. So would love to uh would love to follow up with anyone who's got questions, anyone that I can give a little advice to would love to connect.

Speaker 1 44:03

Perfect ideal. Well thank you very much Karen for being here. Thank you everyone for listening. We will be back to normal scheduling next episode with the lovely Ivanna and Dimi in attendance. So that leaves me to say goodbye have a great day if you've not already had one and we'll catch you next time. Bye everyone great to be here