AI Can Support Clinical Research, But It Cannot Replace Clinical Thinking

It was a great pleasure speaking with Andreas Beust, Andi, for me, CEO of GCP Service, about what is happening now in the CRO world, clinical research, AI, and medical devices. After our conversation, one point stayed with me very strongly: clinical research is changing very fast, but not every faster solution is automatically a better one.

Every week, there is a new AI tool, a new digital health application, or a new company saying that it will make clinical trials faster and easier. I am not against this. Technology can help us a lot. It can support document creation, improve language, reduce some mistakes, and, in the future, help much more with data management and statistical work.

However, in clinical research, faster is not always better. This was also one of the main concerns Andi raised during our conversation. He said that when companies use AI to prepare study documents, the problem is not always the first draft itself. The problem is that without experience from hundreds of trials, you may not know where the document is wrong, where the gaps are, or where you need to think a second or third time.

For me, this is the real risk, especially for smaller medical device and biotech companies. A protocol can look professional and still miss the real clinical or regulatory question. An informed consent form can be well-written yet still not be appropriate for the patient group. A statistical plan can appear complete and still fail to support the study objective.

And for medical devices, Andi made another very important point. Everything comes back to the labeling claim. Choosing the right claim can mean a smaller study, a shorter study, and faster access to the market. But if the study does not support the claim, the company may collect data that cannot be used later.

Many of them depend on external funding. Over the last few years, this funding has become much harder to secure. Inflation, higher interest rates, and global uncertainty made investors more careful. Smaller CROs also felt this pressure, and we now see more consolidation, more acquisitions, and more pan-European CROs seeking to strengthen.

In this environment, the temptation to use AI as a quick solution is understandable. A company needs a protocol. AI can write one. A company needs a study synopsis. AI can prepare a draft. It looks efficient, and sometimes it is.

But AI does not have experience from real world.

It does not sit with a sponsor and ask whether the study really supports the future labeling claim. It does not always understand that in medical devices, the right claim can mean a smaller study, a shorter study, and faster access to the market. It also does not understand what happens if the company runs a trial and later discovers that the data cannot be used.

For a medical device company, this is not a small mistake. Andi said it very clearly: if a company runs a trial that it cannot use later, very often this can be the end of the company. This is why clinical thinking is still so important. For me, this means having people around the table who understand the patient, the endpoint, the inclusion and exclusion criteria, the regulator, and the investor. People who can say early enough: “This looks good on paper, but it will not work in reality.”

Europe is a good example of this complexity. It remains attractive for international clinical trials because the quality is high and costs can be lower than in the US. But Europe is not simple. We have different languages, local requirements, and different expectations in Germany, France, Spain, Poland, the Czech Republic, and other countries.

If a sponsor understands this and prepares well, Europe can be very interesting. If not, the process becomes frustrating.

The same problem exists in digital health. There are so many mental health apps, lifestyle apps, self-monitoring tools, and software-as-medical-device products. Sometimes, even the owners cannot clearly explain why their app is different.

For users, it is even more difficult. Which application should they use? How long should they use it? When should they stop?

In healthcare, a quick solution is usually not enough. We need proof, real data, and a clear reason why this product should exist.

AI will help clinical research. I believe that. It will make some processes easier and probably reduce repetitive work. But it should not replace the people who know how clinical trials really work.

The conversation with Andi confirmed one of the most important points for me: the future should not be AI, but clinical research experience. It should be AI together with clinical research experience.

Only then can technology truly serve patients, companies, and healthcare systems. Evidence must stay at the center. Without it, we are not building innovation. We are only building nice documents.

Thank you, Andi, for a very interesting and exciting conversation, and for sharing your real experience in medical devices, clinical research, and healthcare. Your practical view is exactly what we need more of when we speak about AI in clinical trials.

Timecode:

00:00 Meet Andreas CEO Intro

00:31 CRO Market Consolidation

02:39 AI Hype In Clinical Research

03:37 Where AI Helps Today

06:36 Risks Of AI Written Protocols

09:39 Medical Devices And SaMD Boom

11:12 Funding Uncertainty Outlook

13:40 Investing In Digital Health

17:25 App Overload And Differentiation

21:03 How They Pick Investments

23:13 GCP Service End To End CRO

25:50 Why Europe Still Attracts US Trials

28:02 Europe Complexity Languages

30:34 What Makes Trials Succeed

33:39 Clinical Trials In 10 Years

35:39 Personal Vision And Wrap Up

Links:

Pavlina Walter: https://www.linkedin.com/in/pavlinawalter/

Website: PavlinaWalter.com

Guests:

CEO Dr. Andreas Beust : https://www.linkedin.com/in/andreas-beust-8bb32295/

Transcript:

[00:00:00] Pavlina Walter: Today I would like to invite Andreas voice, called Andy for me. So he is a CEO of the German C-R-I-G-C-P service. It's a great pleasure, Andy, to have you here in my podcast. And today I would like to speak with you about the situation of the CRO Worldwide, the current situation with AI and so on. So welcome.

[00:00:25] Andreas Beust: Thank you for inviting me over. It's always a pleasure being here and getting a chance to meet you once more here in person.

[00:00:31] Pavlina Walter: So actually for our audience, we know each other from the past, but for more than one year, I haven't been in this industry of the CRO. So how the CRO industry has been changed since the last year.

[00:00:47] Andreas Beust: I think overall what we are observing at our size, so for reference we are like early, you know, midsize contract research organization, six offices, 110 people. So if I look from MySpace and, and people that we are collaborating with and that we are familiar with and, and Germany and Europe and beyond.

What we see is a tendency to reconcile and buy up a lot of the smaller CROs that have found it difficult over the last years to maintain a healthy business environment because a lot of our clientele requires heavily on external funding, and the external funding environment has been harsh over the last year.

Particular with increase in inflation, uh, the Russia attack against Ukraine. That has been, um, I think priming or accelerating a reconciliation that we already see so that you have more, let's say pan-European, especially now from a European perspective, CROs that jump a little bit higher artificially into the mid-sized range to be a bit more competitive for the larger global players that still continue to run a lot of the studies in.

I think that has impacted a lot of businesses. I know a lot of smaller CROs that have not been able to sustain business have been bought up. And of course there's a lot of uncertainty also in this year. Very unfortunately, it has not really quieted down in the way that we probably all hope for.

And that's what I observe at the moment. And then of course there is the technological shifts that are currently happening that they're creating uncertainty and it's a phase of reorientation and that always leaves opportunities to grow, opportunities to fail. And it's an exciting time.

[00:02:39] Pavlina Walter: You mentioned there is this influence of the technology, you mean the artificial intelligence? 

[00:02:44] Andreas Beust: I don't know to which extent you have exposure to that, but at least probably once a week or twice a week there is a new company with a new product or tool. Tool, exactly. In which they say, we have reworked how clinical research works, and we are now leveraging artificial intelligence in our tools to support.

Whatever. And then usually the detail is a little bit like, but there's a lot of movement. There's a lot of player moving in and there's a lot of promises being made, and I think the verdict is yet out as to whether they'll be kept or not and how useful it actually is. But certainly we are looking at a lot of optimization potential in these processes and also with the head of technology and there is a lot of movement in here.

[00:03:33] Pavlina Walter: if we speak particularly about the GCP service.

[00:03:37] Pavlina Walter: So where you are using the AI in your services or in your work and workflow. 

[00:03:45] Andreas Beust: So I think the primary points of support are one in language based, like document creation. So everything that you do has to be documented in clinical research and you have to have a lot of like plans and documents. There's a lot of things that are being written and the writing process itself.

Can largely be supported by artificial intelligence. It prevents a little bit of errors occurring that are simply based on duplication of information that is inconsistent, for example. Um, it helps elevate the language standard a little bit. We have a very, you know, diverse team at GCB Service, uh, but very few native English speaking people, although English is the main language we work in, and so artificial intelligence really helps there.

So language-based tasks can be supported. I'm not saying you replace the people, you replace the thought, but they can really be supported and streamlined. And then on the other side, uh, the data flow and managing of, of data really benefits from artificial intelligence as well. But I think there we are not as far as I think we could be.

Programming from statistical analysis, from statistical monitoring and triads data overviews that we create. I think here artificial intelligence can also strongly be leveraged. Now we have also run pilot projects with different tools where, for example, the promises basically you throw in a protocol and you get a statistical analysis plan at an analysis or you create your database from it.

And here we have tested quite a lot of different systems. I have to say that mostly I feel the output is lacking behind what the promise is. And the reason is that the easy 80%, which is maybe 20% of the work, but you get 80% of the volume done that is quickly done. But the study specific details

Where you really need someone to think about what's going to happen in your trial, which has a level of complexity to it. That I don't think is covered too well yet. Now, it could be that it's just the tools that we are using, um, that or that we have tested so far, or it could be that it's a development of let's say another one or two years at the speed that we are currently developing.

So I have hope that this will be streamlined and a lot of the processes that don't really require a lot of. Like mental load can be automated, but there will still always be a lot of processes that are impacted by experience, by understanding, by putting knowledge into context. 

[00:06:36] Pavlina Walter: Um, you extremely well mentioned these experience and the knowledge, because what I experienced lately on it is that.

Companies, like smaller medical device companies are using to GPT for writing study documents, like informed concepts, forum protocols and so on. So do you think that that might have a significant impact on your work or on the data? Which after the companies they will received.

[00:07:09] Andreas Beust: So we have seen. I mean, I have, I get a lot of requests for new projects and I have seen enough synopsis where I clearly can tell that this is entirely generated by ai and I can take it as, um, I.

So I look at it and I see that the core idea was input into an ai and it made the, I like it, put fluff around the idea and probably someone spent a little bit of time reviewing what it is, and I need to extract the core, but then discuss the details because probably they weren't well thought through.

This is how I, what I see a lot. In these requests. Now, unfortunately, I think there is a as you rightfully put, so there is a perception that you can simply throw in an idea into an ai. You get something out, and if you don't have experience from hundreds of trials or you don't have experience of years of clinical research, you don't know where it's wrong.

Where it's right. Where you have gaps and where you need to think a second or a third time. And clinical research is not black and white. You know this as well as I do. Yeah. There is, and especially with medical devices, everything is about the labeling claim.

[00:08:36] Andreas Beust: And you can optimize so much by choosing the right labeling claim, having a shorter study, a smaller study, one that costs you less, but gets you to the market fast and, and artificial intelligence doesn't, no one doesn't care for it.

Or you need to be really precise about what you wanted to optimize for. And I think here. A lot of companies might be missing out if they simply trust themselves to a quick solution and moving ahead. And then at the end of the day, a notified body will know and they will check whether everything you've planned and the study that you've run aligns and supports your marketing claims.

And you don't wanna, especially as a medical device company, run a trial which you cannot use because mostly that's the end of your company. 

[00:09:24] Pavlina Walter: Yeah, this is I experience and hopefully that the CEOs of those company, they're gonna be smarter and then they just use your services, not they will not trust only to artificial intelligence and what they get from those kind of systems.

So you mentioned that you receive lots of proposals from medical device companies. Is it now that you receive more proposals from medical device instead of the biotech or pharma companies?

[00:09:56] Andreas Beust: Well, historically for us, it has always been close to 50 50, which is, I think, unusual already in and of itself.

Um. Medical device research isn't as strong as drug research or has historically not been as strong. There are many medical device companies and many medical devices on the market in Europe, but ahead of the 2020 regulatory changes, we didn't really need as many studies, but we already did a lot of them or, yeah, historically.

So therefore, I would say our ratio may not be represented for the overall market. What. We have seen is that there are indeed a lot of companies, especially in the software as medical device area, which are pushing to the market, and I think some of that is warranted because before with reclassification, a lot of software as medical device were not really medical devices or they were pushed into a lifestyle.

[00:10:54] Pavlina Walter: Mm-hmm. 

[00:10:55] Andreas Beust: Soft corner, and since there is an increasing pressure on having these sort of edge cases classified as medical devices, they are now more moving into the medical device feed. I think here we are actually seeing more.

[00:11:11] Pavlina Walter: Oh, 

[00:11:12] Pavlina Walter: And uh, if you can compare the situation in the Europe and the worldwide, so how the Euro business is standing right now?

[00:11:23] Andreas Beust: Well, again, probably there are some short term well. Lemme put it this way, uncertainty in the world for companies our size always has, uh, an adverse effect on, on our business. We saw this 2023 where it wasn't quite clear how high would inflation go and how long would it persist? And the countermeasure to that is increasing interest rates.

Increasing interest rates, which means all of a sudden projects cannot really be funded anymore to that extent. And this is where we had an impact for around two years or so. Now we are just on the well with a two week ceasefire in Iran. But we had already seen before that prices were rising again.

That causes uncertainty, that causes a pause in private equity and venture capital investing and funding, um, especially smaller projects. So. F my perspective on my or on this year was very positive. Going in. And in the last few weeks was, was getting a bit more cautious, and I'm speaking for the small to mid-sized mm-hmm.

Companies and therefore also the mostly early phase, small, externally funded projects, the global projects, they still continue and we see. I feel every week another billion dollar plus valuation of a company that's been bought by one of the global pharma companies. So there is a lot of monies to push in the system and clinical research will always continue.

It has to, we are getting older, there are more diseases, we are getting better at diagnostics. We have much more data on ourselves and that enables much more treatment opportunities. So. With more research enabled and with healthcare spending growing basically globally, there will always be a need for new medications, for better treatments, for cheaper treatments as well.

So that will always continue. So I remain long-term positive on clinical research for sure. But short term, again, there might be some turbulences and I guess especially startups and small biotechs might feel that more than established pharma companies.

[00:13:39] Pavlina Walter: and, um. You are not only a pure CRO you are only, you are also the investor.

[00:13:46] Andreas Beust: Correct? 

[00:13:46] Pavlina Walter: Yeah. So through which company are you actually invested the money and why, and which company are you are choosing? 

[00:13:53] Andreas Beust: Mm-hmm. 

[00:13:53] Pavlina Walter: As now everything is shifting to digital health. 

[00:13:56] Andreas Beust: Yeah. Correct. So. We invested a couple years back. Uh, and I say we in a, in a broad term, but let's say within the, the GCP service group, uh, invested in a medical device startup, uh, called Skin Vita, and that's, uh.

Their device is an app combined with a physical adaptor, and the adaptor is used to regulate power for a UV lamp, and that UV lamp is used in treatment for mm-hmm. Skin disease. So they are class two, a medical device because the lamp is class two A. Um, and, uh, they enable home treatment of patients. They received the CE certificate, uh, about a year ago and.

They, that has been a project where the investment, frankly speaking, was largely also driven by the founding team. They have, uh, a person that was excellent at it and they had a person that really drove, and that was the key here, really. They drove the company vision young, with his clear vision, being a patient himself of the need.

That really sold the idea it was a local company from Breman and with such a leader as Y on the helm. And then having the technical support, uh, and understanding that we can supply the regulatory support to their internal team, uh, which was also greatly set up. That was the foundation that we wanted to see in a company and invest in it.

And since that time we have evaluated many different companies and we have also looked at one service. Yeah. Software based medical device, which is for, in the German regulatory system, was supposed to move into a dga. So digital health application space. And that was something that we thoroughly looked at and were willing to move ahead, but at the end of the day, it didn't really work out.

Now we are a little bit torn as to whether DGA is the direction to go because it's a system that's now been running for some time and there's a lot of work that's being pushed in the direction of digital health application. And not all of them might be. Fully market ready. And the, the requirements are extremely high for digital health applications compared to a normal medical device that you get to the market.

Randomized control trials is the default, which is very unusual for medical devices. Especially smaller and software based ones. So it comes with its own hurdle and maybe the system will change a little bit. So we are cautiously evaluating it, but nevertheless, we are still looking for primarily for the right team behind the idea.

The execution is what matters. We can support in from a monetary point of view, but also bridging the regulatory piece. We know what it takes to get to the market, but we are not gonna drive the idea. So as long as you have someone there. You really feel the dedication to the project and the inspiration really hits you when you talk with them.

That's lovely. And those are the people that we are happy and willing to support. As long as we understand the product and we are really like we are investing, then. In, in something that we like, something that we understand that we can move to the market, but with a team that drives it. 

[00:17:25] Pavlina Walter: I fully agree, and I think that nowadays with this huge amount of the new application every single day, even the.

Owners of those company have no clue why. They're like, in which part they are different than the others. So it's very, very hard to even distinguish. Yeah. I always comparate like with this, um, health supplements, like nutrition supplements, yeah. That you have a million of the magnesium, you know which one you can choose.

And it's the same like with the application for it. Mental health. So you, you also dunno, so you just either choose the application because you like the color or you know who is behind. Yeah. So I feel agree that it's always about the people and the team behind. 

[00:18:09] Andreas Beust: Mm-hmm. 

[00:18:09] Pavlina Walter: You can, uh, be very patient about their work and the idea why they are doing it.

So yeah. 

[00:18:16] Andreas Beust: My, my wife is a psychotherapist. Oh. Mm-hmm. And she, for her, it's the same. So there probably, I don't know, once a month or may at least, it feels to me like that someone is calling up and saying, there is this new mental health application, so for your patients and don't you wanna advertise it? And she always says, no, I don't want to advertise it, because one, there's way too many out there.

Mm-hmm. It takes a lot of time to, mm-hmm. If you wanna recommend something and you put your name behind it, you need to really understand it well. You need to understand the differentiators, how this is not possible unless you put a tremendous amount of work in it, because everyone is really very supportive of their own ideas and their own differentiators.

But if you look at the spectrum of applications that, that are being brought towards her, uh, saying that we can do this and we can do that, and we have a specialty here and we cover this element, uh, or you should use this for these patients. It's at the end of the day, you would have to trust someone that wants to sell you their product.

But the differentiator is not really clear. And, um, we, we evaluated an app and, uh, four similar apps. So I asked my wife, I told my wife because it was in her domain, and she come back and said like, yeah, here, look, these are all the flies I have from other companies that do exactly the same thing. And so then the question becomes, okay, where's the differentiator?

What can we move forward with and think about it as a patient also? Mm-hmm. Like how we, how, how do you. Think patients will go through a day in a life of being a patient already and then having to face, I don't know the issue of deciding which of the applications to use, which of them are gonna help them most.

How long to commit to using one before you think you should change? I don't think it's, it's very easy and straightforward and. Some, some of them more, but we 

[00:20:03] Pavlina Walter: also, this kind of application is always like a quick solution. 

[00:20:06] Andreas Beust: Yes. 

[00:20:07] Pavlina Walter: Is the same like with the anti drugs because, um, also how long you are able to use the application.

Yeah. You use it once, twice, three times and then your interest is actually lower and lower and doing right now, the. Experience to see if pregnant women are able to use the application for like 20 weeks. 

[00:20:28] Andreas Beust: Hmm. 

[00:20:29] Pavlina Walter: And, uh, I will be very curious about the results. Yeah. Because the study is finishing, uh, soon, but definitely it's nothing like easy.

That's always also the companies who are developing it, they need to think for who they are doing it. Mm. And how long they think that the patients or the users will be using it. Right. So, right. Because other than that, it has no sense to develop more application that they are right now mm-hmm. On the market.

And I don't think there's, somebody is coming with some kind of Mira application nowadays. Yeah. With this, with this environment. So, so right. As an investor, you're right now, uh. Maybe thinking to if anybody is coming to you mm-hmm. That they would like actually to know your opinion, you would invest the money to their company.

Mm-hmm. So you are open, but you do your own evaluation. Yeah. 

[00:21:20] Andreas Beust: Yeah. Absolutely. Yeah. So mostly I do, well, it's either myself or myself and Andreas. We are jumping into meetings with the founding team to get an idea of the. Product one. Mm-hmm. But also more importantly or very much tied to it, the people behind that, who are they?

How well can they sell the idea to us? Because that's the spirit. They also need to bring the idea forward. It's usually not like one investment round, it's multiple ones. And you need someone really thrive and passion and, and what's the connection between the founding team and the device, if that's what feels purely monetary, that someone, you know, finished.

University and then said, well, I, I should, you know, start my own company. What, what is the thing that I can do? Well, you know, coding is easy now, so let me develop an app. We have had pitches that feel exactly like that, that someone simply decided I want to be a founder. So the easiest thing I can do is I create an app.

Well, actually I need to someone else to create the app for me, but I would love to be the founder of the company that, you know, says and develops it. And at that point already, the conversations is pretty much over. Um, and at other times we need to feel like we can add value to it. We don't only want to invest money.

We want to invest in projects where we feel we can support and we can really be an asset from a. From a stakeholder, it's, it's not only like, we don't wanna be just a bank, we wanna be someone that is a strategic asset in the development and then can de-risk the process and increase the likelihood of success.

Um, that's, that's really what we, what we are here for. And. Uh, otherwise it's, um, always I think great to see what ideas are out there. Some are a little bit more obscure and some are, uh, some are very interesting. Okay. 

[00:23:13] Pavlina Walter: Coming back to the CRI service. So, um, you, um, as I know, and I, if I remember still, well, you offer all your service in your house.

I mean, so you are not outsourcing, for example, data management or STAT to anybody else, so what kind of services you provide. If they, our public has no absolutely clue what you are offering. 

[00:23:35] Andreas Beust: Mm-hmm. So that's indeed quite a unique differentiator at our size. So if you go to the Globals, of course they have everything in house, um, but mostly our size, sometimes even a bit larger and for sure when, when companies are smaller, as you highlighted, a lot of what is considered more central service is outsourced.

Uh, so the typical CRO starts with. Project management, uh, regulatory submission and monitoring. And a lot of the CROs also stop there because then they have collaboration partners that do data management or biostats also on, but we actually do everything in-house and, uh, also for, for many years already.

So we have our own team of data managers of Biostatisticians, uh, own product vigilance team. Uh, we have our document management team, including our own ETMF and EISF. And uh, yeah, project management, regulatory and monitoring of course as well, so that at the end of the day you can end-to-end run everything with our own internal people.

Mm-hmm. And then of course, we should perform a study. You can find patients the easiest and that of time, or many a times means we also go into countries where we don't have a presence ourselves. Mm-hmm. Although we cover like 12, 15 countries, uh, with our own team 

[00:24:55] Pavlina Walter: in Europe. 

[00:24:56] Andreas Beust: Um, yes, everything in Europe, basically from like Ireland, UK to to Hungary mm-hmm.

Is basically the width. And then like from Germany to France, uh, and, and anything in between. So. And when we go outside of these countries, we then work, uh, with, uh, long-term partners, a lot of which are members of the Association of International HEROs, uh, which I also serve as a president. And that helps us go where the patients are and where it's most efficient from a costing a timeline perspective, from a regulatory scope to run the project.

And we can still manage all of that together centrally here from Europe. 

[00:25:37] Pavlina Walter: So for the clients in case they would like to run the trial in the Europe and in the USA, you are absolutely able to do it. 

[00:25:45] Andreas Beust: Yeah, absolutely. Not a problem. We run those studies already and we would be happy to take on new ones in that scope as well.

[00:25:50] Pavlina Walter: And do you think for a, the clients abroad from US clients still is the Europe interesting, uh, continent? 

[00:25:58] Andreas Beust: Mm-hmm. So. I think the, the 2020 to 23, even 24, and then also moving into 25, you could feel some hesitancy because we changed some so much of in our regulations, uh, for, for drug trials. It was a new clinical trial regulation that centralized the process and no one really had a lot of experience with it.

Mm-hmm. And uncertainty. Mm. Sort of dissuades. People from, from coming to a place. The costs are, I feel secondary. I mean, this is hard to say, but mm-hmm. Because costs are always important, but from my perspective, costs are secondary to certainty. If you know something will cost you 10 million, but you can do it.

You will do it. If you know something else costs you 8 million, but you're not sure if it'll work or not, you'll go with 10 million option. Um, just like as a, as as an example. And so I think this is what sort of like swayed off US clients from going to Europe for a time, unless it was relevant for their regulatory strategy or, uh, they had enough familiarity and said we still wanna push for it.

And on conferences I've been attending as of late, that mindset has shifted a little bit. Mm-hmm. Um, and there was a little bit more positivity towards European Union, more reliability. And we could also see over the last two years, a lot of changes were implemented that were also meant to make the process one easier and two more predictable, and three a little bit faster.

Especially when it, when you look at single European country submissions, uh, being expedited and so on. So if you then look at the overall scale and say Europe is, let's say half the cost of the UA us, then all of a sudden you get an incentive on top of that. So once reliability increases and monetarily Europe is still offers exceedingly good quality, but at a much cheaper price than the us then it's really interesting for people coming from abroad and seeing that part of my data will be gathered in the us.

Part of my data would be getting Europe. 

[00:28:02] Pavlina Walter: Yeah. But always there is a question, or there is this afraid for the clients that Europe has many different status languages. So how you'll be able to manage all of that. Yeah. For most of clients, the US it's very easy. Uh, so that's, um, you don't think that that's a disadvantage for the Europe?

[00:28:21] Andreas Beust: For sure. It's a disadvantage. Uh, I think if we had an, an official English is fine in all countries. Uh, statement. If we didn't need patient facing data, uh, or, or documents mm-hmm. In local language, which we always will. And, and so that will not change. Of course it would be easier. So this is a disadvantage.

And even with the centralized system, I know that we have different requirements in Germany, to France, to Spain, to Poland, to Czech Republic. Uh, the differences have really decreased and that's positive. But I'm not going to be here and pretend that Europe is not, from a regulatory perspective, a little bit more complex.

Now, this impacts the first, well, let's say six months of your trial. Mm-hmm. Two months preparation, four months for submission. That's something for multinational, uh, trial, which you can pretty much expect in Europe. So yes, this is that six months versus maybe four months in the us. Mm-hmm. Um, from, from like really start to, to regulatory approval.

And then you have, uh, in the US you have your large population that you can enroll across the United States. In one goal. In Europe, you have one approval for our countries. You submitted and probably. The patient population that you're looking at will at most be comparable unless you really include a lot of European countries.

So it does come with an added complexity. It does come, uh, with additional effort. A lot of the effort is offset by difference in costs, uh, for the submission process itself, for the staff to manage it. Mm-hmm. Um, so. That's there, but I can understand the hesitancy of, of going in Europe. I think it is much more reliable and much more straightforward these days than it was pre decentralized system.

And there's a lot of great experience that we have in ensuring that it can actually work. 

[00:30:23] Pavlina Walter: Okay? So the clients, they don't need to be afraid. You will always find a solution how to make their clinical trials alive. And it's successfully finished. I have a question. Do you have any kind of signal or marks how you distinguish that the study is gonna be successful or not?

Or how difficult it's actually to, uh, plan and project the objectives for this study and points? Because sometimes it needs to, it must be very, very, like difficult and sometimes I think that even the clients has no clue what they're searching for. 

[00:30:59] Andreas Beust: Yeah. I think the endpoints do come with difficulties, but I feel more often it's the inclusion criteria and the exclusion criteria that make or break a clinical trial.

Uh, the basically perfectly healthy patient is usually, I mean, we all know the disaster. Uh, if you have 40 eligibility criteria. 50 or 60. You know, there are some, some trials we have like 25 inclusion criteria, 30 extrusion criteria. Reasonably. You should anticipate that it's gonna be very difficult for you to find even one patient, let alone enough to then establish statistically that your treatment works in the way that you planned with your sample size Now.

It is always a trade off. The more broad you include a patient population, the smaller the differences between, or your treatments are gonna be, uh, the ones that are relevant for the primary endpoint anyway. And so I can understand the consideration saying in, but we want the perfect population because then we have the highest chance of showing a big difference.

And that's great for us. But if you don't find those patients, it's not helping you anyway. So. There is a lot of discussion and back and forth and really getting feedback from boots on the ground, people that actually see those patients and can understand what the risks associated with certain eligibility criteria are, and weighing that against the impact of maybe loosening some of those restrictions and including a wider population.

And, and then you, you throw in them to the mix that you might not know what it does with the safety profile of your product. You only have one shot. So I understand it's a pressure cooker. We have a lot of pressure that the study needs to be successful and you wanna optimize all of the ends and you cannot optimize all of the ends.

And I love it like this is, it's challenging. Yes, but I mean that, that's what makes our job so great because it's not easy, because you really need to think hard about it. And of course, I would wish that. Developing a new product would be very easy and straightforward, and it's a fast process. We would all benefit from it.

Mm-hmm. After all, we are all patients, uh, at one point or the other in our life. So, uh, but getting to be a part of that journey and, and helping balance those opposing forces in a clinical trial is something I really found fascinating. 

[00:33:39] Pavlina Walter: And where do you see the clinical trials in 10 years? 

[00:33:42] Andreas Beust: Ah, that's really interesting questions.

I know of course of these prediction of clinical trials declining because we have virtual twins. Interestingly enough, we are currently collaborating on a grant application. We're also part of that project will be virtual twins. So we will collect data and we will create virtual twins and then evaluate outcomes based on those as well.

And. I find it very fascinating. Yet I feel we are only scratching the surface of human complexity in terms of biomarkers that we can look at. Understanding really the, the physiology and, and the makings and interconnection of a human body. We have a wealth of knowledge, but we have no clue how much more we don't know and how much more complicated and intricate it is, and that's why.

I think a lot will happen in terms of simulations and data and, and pulling together all of the different biomarkers that we have more and more and more of now, which will give us a much higher predictability and a decreased failure rate in the drugs that we develop and test, and that will ultimately bring down risks of development of.

Of all of our medications, which will bring down prices and which will make clinical trials much less risky. From a safety perspective, from a clarity of outcomes before we move in, we will not get rid of them entirely, at least for sure, not in the next 10 years. Who knows what will happen in the future.

I think a lot of stuff can happen and probably. This direction will move a little bit faster than regulators were. So the question is, when will regulators catch up and really allow that level of synthetic evidence to support your primary submission? So I think here in the next 10 years, we will see a lot of stuff, which will be very fascinating.

[00:35:39] Pavlina Walter: And the last question, so where do you see yourself in 10 years? 

[00:35:45] Andreas Beust: 10 years?

Well. Still with GCP service. I think, um, already now, I think sometimes I still, for my personal opinion, I sometimes still do a little bit too much, uh, like admin stuff and gen general things. I would love to see that at that point. I am consulting much more so I am consulting a lot already, but consulting much more and.

Also much, much like earlier involved in the development pipelines, both for medical devices and for drugs in a consulting role, and, and really supporting entrepreneurs that are looking to embark on that journey in finding the right means and addressing the right questions at an early stage to help them develop further.

This is something that I'm involving myself in more and more and more as time goes by. And I really love sharing that knowledge and that message, and I would like to do more of that and make that easier to access. You know, I'm very much driven by the idea that clinical research should be easy.

Although it's a source of, of course, of providing work for 110 people at GCP service. And beyond that, of course, in the wider industry. It's so impactful for us that we should really make it accessible, and that's what I wanna work on more. And in 10 years, I want to see that I have come a long way in making that happen.

Making more information, more accessible, sharing more about clinical research and, and providing information out there to help the development of new products, new new devices, reach the market with less risk. 

[00:37:30] Pavlina Walter: Chris, so I wish you lots of success on your way to make your dream happen. Thank you for this interview.

[00:37:39] Andreas Beust: Thank you, pav.