The Transparency Mindset: Why Clinical Trial Results Still Go Missing with Andrew Freeman

Andrew Freeman spent over two decades at GSK, where he led the company's efforts on clinical trial transparency - trial registration, results reporting, and sharing patient-level data with researchers. Yet when his own father was diagnosed with late-stage cancer, he couldn't find him a trial through clinicaltrials.gov. He gave up and found one through a personal contact instead. As Andrew puts it, that shouldn't be the way it works.

Andrew was at the WHO meeting in Geneva where the 20 or so data elements for study registration were identified, and since the end of 2022 he chairs the board of ISRCTN, the UK's clinical study registry.

In this episode, Andrew and Maya discuss:

• Why a "compliance mindset" and a "transparency mindset" are not the same thing - and why studies outside the regulatory definition of a clinical trial should still be transparent
• What the latest HRA metrics really show: 94% of UK studies registered sounds good, until you see that only around 44% published their results
• How ISRCTN is trying to make transparency easier - mandatory plain language summaries, mandatory recruitment site information, and a results posting system now in its second prototype
• Where AI could help make trial information understandable for patients, carers, and the public

Creators and Guests

Host

Maya Zlatanova

CEO of TrialHub

What is Trials with Maya Z?

90% of clinical trials fail, 85% get delayed. Let’s deep dive into the world of planning and running of clinical trials with some of the most experienced and passionate people from the Industry and find out what makes trials more successful or more challenging. Welcome to Trials with Maya Z podcast!

Maya Zlatanova, CEO of TrialHub: https://www.linkedin.com/in/mayazlatanova/

Maya Zlatanova (00:01.59)
All right. Hello, everyone. It's Maya from Trials with Maya Z. I'm very excited because I haven't recorded a new podcast episode for quite some time, but I'm even more excited because maybe two years ago, I interviewed an expert in clinical trial transparency, a guy called Till Bruckner, Bruckman, and he absolutely opened my eyes for

the need for transparency in clinical trials. And then I recently met Andrew Freeman, who is here with me today. And Andrew, actually, when I started researching about Andrew, I actually realized that Andrew is one of the most popular and experienced people in the UK when it comes to clinical trial transparency. Andrew is behind several initiatives to contribute to clinical trial transparency. So I am, again,

repeating the same word, excited, but very, very much excited really, that I have Andrew here today with me to actually discuss exactly clinical trial transparency, but not only that. Before we dive into some of my questions, and I have many, Andrew, why don't you start with just giving us a little bit of a background of yourself?

Andrew Freeman (01:15.074)
Thank

Andrew Freeman (01:20.78)
Sure, thanks, Mayor. I'm pleased to be on this podcast with you today. So I'm obviously Andrew Freeman. I worked at Glaston Smith Klein for many years, a couple of decades and a bit at Glaston Smith Klein, where I latterly was involved in clinical study transparency. I say latterly, I've been involved since about 2005.

a meeting at WHO in Geneva where we identified the 20 or so data elements for study registration. I was at that meeting. So I go back a long way in terms of clinical study transparency and I led GSK's efforts in that area. So registration results, reporting on registries and also sharing patient level data from clinical trials.

I left GSK a few years ago now and was fortunate enough to get a role at ISRC-TN, the UK's clinical study registry, where I chair the board. So I've been doing that since the end of 2022. So for a few years now, I've been leading that team at ISRC-TN.

Maya Zlatanova (02:42.882)
Thanks, Sandra. I'll start with your actually achievement of GSK because to me it is a true achievement. Back in the days, you led the initiative to actually allow patients to get access to their data. that's, I mean, unfortunately, that's still a conversation, ongoing conversation. So I can't say that.

Years later, we've solved this problem. How do patients access their data? Can you tell us more about this project? What led you actually to start working on that? And what were the main challenges back then?

Andrew Freeman (03:16.215)
Yeah.

Yeah, so the initiative was really about sharing patient level data, anonymized patient level data, with other researchers and scientists for them to use that data in further research. It wasn't geared to sharing those patient level data with patients themselves, it was for other scientists. But the patients were at the heart of it. And why I say that is that

Maya Zlatanova (03:33.485)
Mm.

Maya Zlatanova (03:41.1)
Okay.

Andrew Freeman (03:48.77)
The kind of core was the belief that patients...

consent to go into clinical trials on the basis that their information will be used to further scientific knowledge and further help future patients. And so a way of meeting that ethical agreement, if you like, with patients is to share the results, obviously, but also share their data with others so that their data can be used to maximum effect in furthering scientific understanding and hopefully.

medical breakthroughs in the future. So we saw it very much as, as if you like, completing the circle between patients entering clinical trials and then also sharing their data with other researchers. So that all the data that they provided for that initial clinical trial and then subsequently is used to maximal effect. You asked about kind of lessons learned. I mean, I think the biggest one that I would take away from that experience was if there's a will, there's a way.

So there are many issues, know, privacy is an issue, consent is an issue, commercial considerations are an issue. All of those things, absolutely important considerations, but they can all be managed if there's a will to do it and to do it for the right reasons. So it's very easy sometimes to have an idea like that and be, and thought, well, it can't be possible because privacy rules, it can't be possible because of X, Y or Z. My learning was actually, there's always a way.

Maya Zlatanova (04:55.714)
Hmm.

Andrew Freeman (05:25.666)
to achieve it if you have the of the goal in mind and have a great team. I was very lucky to have a great team to implement that with me. And I would also say great GSK leadership to have the vision to do this as an industry leading initiative. So all those things came together. wasn't absolutely I won't take all the credit for it was a team and the leadership and vision from my leaves at GSK at the time.

Maya Zlatanova (05:39.82)
Hmm.

Maya Zlatanova (05:54.115)
Yeah, it's always a team actually that makes a difference. mean, maybe there is a single person that actually is pretty good in communicating the vision and so on and so forth, but there should be a team actually aligned around the mission to overcome all the challenges because like you said, there are many challenges. like I said, unfortunately, even today, this is not something that we've solved completely. And it's still a problem that I'm hearing over and over again, being repeated and

Andrew Freeman (06:04.883)
Absolutely.

Maya Zlatanova (06:23.726)
like something that we haven't solved completely, but it's good that we already have some positive examples. Andrew, wonder, you mentioned some of the, you mentioned the main lesson, but I wonder, did this experience in any way inspired you or led you to actually start working on the clinical trial registry?

Andrew Freeman (06:44.236)
So I mean, guess at the time I was already working on the GSK clinical trial registry. And I think, you know, my long standing experience in clinical trials, registry and transparency going back, as I said, right back to the 2000s, has given me kind of a perspective that clinical study transparency is fundamentally important for the science to progress. But it's also fundamentally important for engendering trust.

in the clinical research enterprise and central to that for me is making sure that we respect and trust patient contribution to clinical research and I think the sharing of information, making sure results are out there is a way of engendering that trust. Now think there's a lot we can do in there particularly in making those results understandable for those who have participated and indeed understandable for the broader community. Obviously

A lot of results you see out there are geared towards communicating with fellow scientists and fellow researchers in that area and are very therefore difficult to be able to navigate if you are not an expert in that area, if you are a participant in that study or if you just have some interest in that area, they're very difficult to navigate, which is why think the initiatives around translating that science into more easily understandable.

format, pain language summaries, etc. are very important to be able to engage that broader audience and engender trust in the clinical research enterprise. Because without trust the whole thing falls down, right? You don't get patients participating in clinical research and if you don't get patients participating in clinical research you don't get medical breakthroughs. You don't get medical breakthroughs then we all suffer in the future. So to me it's a continuum and we must

make sure that we respect and trust and respect patients and engender trust in the clinical research.

Maya Zlatanova (08:46.625)
Now it makes perfect sense. You actually mentioned a lot of aspects of the clinical trial registry, but let's take a step back because I had many guests on my podcast speaking about the clinical trial registries worldwide. And I think it's fair to start with actually what's wrong with the existing clinical trial registries from your perspective and what is the main difference you want to bring in the ISRCTN.

Andrew Freeman (09:16.502)
So starting with a negative question, what's wrong with them? I guess I'd start with what's right with them. So what's right with them is I think they provide a way, standardized way to provide transparency of clinical research from the start prospectively through WHO standards, all trials being registered on a registry, that information being provided on the WHO portal as well. So I think they are very good.

Maya Zlatanova (09:22.006)
Okay.

Andrew Freeman (09:46.13)
provide a great service. In particular, that information on registries can be utilized to enhance recruitment of clinical trials, patients and their carers going into these registries to look for studies that are available. And indeed, ISRCTN has a link through to a port in the UK called B-PART of Research, which is geared exactly for that, for patients to come along, try and find studies that are relevant to them or

carers coming along to find studies relevant for the people under their care to see if they can find studies. And I think that's really important and part of the registration of studies, enabling patients to find studies, but also obviously to create a public record so that studies can be tracked to full publication. So I think registries are fundamentally good before we get into how can they be enhanced and improved.

And I can only really speak to the ISRC TM piece of it because it's the bit I know the most about. And we've done a lot of work. Yeah.

Maya Zlatanova (10:51.407)
Can I interrupt you here, actually? Because when I asked you this question, and I very much liked what you said, but your lens actually is more coming from the UK infrastructure. And I want to comment on this because I've been working with, so throughout my work at Find Me Cure and Trow Hub, I've been working with 76 different countries. And there are a

Andrew Freeman (11:04.428)
Yes.

Maya Zlatanova (11:20.493)
I think on top of my head 17 or 18 publicly available clinical trial registries. And I've been following the clinical trial registries landscape in general. And overall impressions that the UK infrastructure is probably one of the best ones worldwide. And everything that you said is actually completely true, but with a caveat in the UK. But outside of the UK, there are very few countries that

Andrew Freeman (11:38.38)
Okay.

Maya Zlatanova (11:50.094)
I'll give you one concrete example. Think of the clinical trial registry as, okay, you have one place for over transparency information sharing and so on and so forth, but you also need another place for the patients. Like I'll give you an example in the States. I mean, there are many websites, get me wrong, many providers, also businesses that help you be part of research, advertisement on the TV and whatnot. However, city.gov, no matter the enhancements,

is still not a place for clinical, I'm sorry, for patients and caregivers to go there and really be supported. I still remember like, I don't know, 12 years ago when I was searching for clinical trials for my sister, how difficult it was to understand the information. And even after the revamp, one critical thing that I still see happening there is like, who do you contact? I mean, okay, I see something. I may understand it better. Now AI may help me even further.

Andrew Freeman (12:32.597)
Yes.

Maya Zlatanova (12:46.765)
But then what do I do next? And the call centers haven't been as helpful as I think. So everything that you mentioned is absolutely true in the context of the UK infrastructure. And they're not just the registry. There are many other aspects that the UK government just thinks proactively in doing research more accessible in terms of industry and in terms of patients. So I want to make sure that I make this caveat. And I see you want to say something.

Andrew Freeman (13:12.098)
No, I agree with you. So my late father unfortunately had late stage cancer and I was looking for a study for him to participate in. you know, I've got a long, long history in Transparency and Clinical Trials. Don't worry, Dad, I've got this. I'll go to clinicaltrials.gov and find you a study. I could not find, you know, I'm sure it was there, but I couldn't, it was very, very difficult. And I supposedly know a little bit about what I'm doing.

Maya Zlatanova (13:22.009)
sorry to hear that.

Maya Zlatanova (13:33.369)
Mm-hmm.

Andrew Freeman (13:41.014)
could not find a study, it was very difficult to pull out relevant studies, to go through those studies, to find contacts for those studies. And I gave up in the end. I didn't use clinicaltrials.gov. And what I did in the end was use a contact through my network, who was an oncologist who put me in touch with a hospital in London that was running a trial and I got him on a trial that way. But that shouldn't be the way it works, right?

It shouldn't be through personal contacts. I was lucky enough to have a contact and was lucky enough to connect my father with a trial in London. But it should be better than that. It should be more engaging than that, which is why I think you're right. The UK's initiative would be part of research for patients to go to a portal which is geared for patients. So it's not the registry. It is a portal. It's using registry information, pulling out

Maya Zlatanova (14:09.614)
Yeah.

Maya Zlatanova (14:13.603)
Exactly.

Andrew Freeman (14:38.24)
certain information from our registry, pulling out in particular our plain language summaries, which we require for registration and utilizing that in a patient portal. So I think you're right. think patients coming directly to registries is not ideal, but utilizing that information or key parts of that information for a patient portal, I think is a good way of working, absolutely.

Maya Zlatanova (14:55.94)
Mm.

Maya Zlatanova (15:01.743)
Yeah.

Maya Zlatanova (15:07.152)
No, absolutely. Let's go back to the ISR CTN. I keep reading that name because the abbreviation is quite big. when you first started working on this registry, obviously your goal was improving the clinical trial transparency. I wonder, on one side, it'd be awesome to understand how do you understand clinical trial transparency. So actually, let's go with this one first. What does it mean for you, clinical trial transparency?

Andrew Freeman (15:13.268)
Yes.

Andrew Freeman (15:34.114)
Good question. I guess I'll break it down into four elements. So I think it's about registering your study at the start to, as we've already discussed, so that there's a public record of your study that can be tracked to publication. I think it's about posting your results on a registry as well. And I think it's about publishing your results in the scientific literature.

Maya Zlatanova (15:43.856)
Mm-hmm.

Andrew Freeman (16:03.028)
And I think it's also, as we've already touched on, sharing your patient level data from your study with other researchers. So I would frame it around those four things.

Maya Zlatanova (16:15.884)
Okay, thanks for the clarification. When you first started the registry, what were the main challenges at the very beginning?

Andrew Freeman (16:19.713)
Hmm.

Andrew Freeman (16:23.426)
So I was fortunate enough, ISRC-TN has got a very long history and it's very well established, well regarded, very good feedback. So it was already a very good registry when I came on board. What we've done since I've come on board is move our focus a little bit to be more UK focused. So the I in ISRC-TN stands for international and absolutely we're open to...

Maya Zlatanova (16:29.881)
Mm.

Andrew Freeman (16:52.686)
all countries studies, but we are focused on being the UK's clinical study registry. So we've had that focus, which is part of our strategy. We also were very clear in our strategy that what we want to do is to make it as easy as we can for people and registrants to register their studies with us. We didn't want to make registration in any way kind of a barrier for transparency. Now,

Maya Zlatanova (16:56.304)
and the UK.

Andrew Freeman (17:20.46)
There are requirements. I'm not saying it's, it's, you know, just press a button and you're done. Of course not. But what can we do to make it as easy as possible to register your study and also as easy as possible to get information out? So, so what our strategies have been about is about making it easy. What have we done around that, strategies? Well, we, last year we launched or revised our registration form.

Maya Zlatanova (17:23.76)
course.

Andrew Freeman (17:49.644)
So over the years it has become quite cumbersome. So people have various good ideas. Why don't we ask for this? Why don't we ask for that? And are quite a number of fields on that form that are outside the WHO requirements. So we've streamlined that form, focusing on WHO requirements. We've got other fields as well. So managed requirement is for a plain language summary because we fundamentally believe it's important that there is something there.

Maya Zlatanova (18:15.141)
Yeah.

Andrew Freeman (18:16.438)
so that patients and others can understand what the study is about. And we've also got, which is important also for patients and others, make sure we've got the center information where patients are being recruited is mandatory as well. Other fields, we're very clear that we label those as being optional. But again, all that is about trying to make it easier for people to register studies. In addition, we're very clear that we're trying to make it as broad as possible.

Maya Zlatanova (18:29.777)
Mm.

Andrew Freeman (18:44.62)
So not just for your interventional clinical trial, but also providing a way for other studies, observational studies to be able to be registered because the same transparency principles apply to observational studies as they do to clinical trials. And so we wanted to make sure that we're as broad as possible. So we've done that. And the thing that we've been working very hard on over the last 12 months is a system through which

registrants can post their results. So I'm sure you're aware last year, May I think it was, WHO in a Lancet article described what registries should capture in terms of posting results. So we've been working very hard to develop a system through which researchers can systematically post their results. Again, with this making it as easy as possible as our strategy, where we actually launched our second prototype this week.

Maya Zlatanova (19:17.283)
Awesome.

Andrew Freeman (19:44.45)
on Tuesday, which is available for people to review and see the direction of travel on that system. So that's another thing that we are doing. And also this process as well that goes with that. So making sure that we are engaging with registrants, giving them reminders. So making sure the 12 months from completion is approaching.

reminder for them to post their results, all those kind of things in the background around process to make sure that transparency principles are adhered to. So there's a lot about the system but also about process as well to try and make it as easy as we can for researchers to be transparent. So let's look some of the highlights that we've been working on over the last 12-24 months.

Maya Zlatanova (20:37.891)
It's awesome what you mentioned about the results. And I also have some questions on the registering of the clinical trial. But before that, I just wanted to share with you, after our preparation call a few, I think, like a few weeks ago, or like two weeks ago, I decided to post a LinkedIn post. A LinkedIn poll, sorry. Just to check what do.

What does my network there, clinical research professions, what do they think in terms of how many, what's the percentage of clinical trials publishing their results? I did some check beforehand what the data says, let's say. I wanted to see if people have kind of accurate expectations. So it turns out that people are more pessimists. So it turns out that 64 % of the voters

voted for below 25 % of clinical trials post their results after they're completed. And only 24 % said that just about 50%. And actually, I checked several articles on the topic. It depends on the country, but around 40 to 50 % of clinical trials post their results. These are the official, let's say, numbers. So it looks like that people don't trust that.

And these are people from the clinical research industry, like most of them, they don't trust that clinical trials results will be published. So I hope that will change this trend. And hopefully with this registry and other registries pushing towards results publishing, we will see more trust in that because it is important not just for industry, for the patients themselves.

but also for all these people working in this industry. Many of them joined the industry exactly because they think that they're contributing to something like for better for our future, for medicine, for people's health. And so knowing that there is a collaboration and transparency is very much like key. Going back to what you mentioned about registering the clinical trials, I wonder...

Maya Zlatanova (22:52.365)
which because clinical trials are done by various types of institutions, some of them private like the businesses, pharma biotech companies like seros, others academia sponsored, governmentally sponsored as well. I wonder where do you see the biggest resistance when it comes to willing to register their clinical trials and share more information about their clinical trials?

Andrew Freeman (23:16.898)
So, yes, good question. But I think before I go into that, you mentioned kind of some of the percentages around transparency. And you may be aware the HRA recently published the metrics for UK clinical studies, I think, from 2024. And I think they're illuminating, illuminating in a number of ways. So the number of studies that were registered, right?

Maya Zlatanova (23:23.471)
Yeah.

Maya Zlatanova (23:41.296)
Okay.

Andrew Freeman (23:45.282)
94 % were initially registered, right? So can say, great, let's move on. But let's pause a little bit. So it's 94 % of around about 1300 studies. So that means around about 80 studies weren't registered. So that weren't registered, right? So the 94 % looks really high. You go, well, that's fine. Let's move on. But hold on. Let's look at that again. Why weren't 80 studies registered? And there were...

Maya Zlatanova (23:45.829)
Mm. Mm-hmm.

Maya Zlatanova (24:02.736)
weren't registered. Okay.

Yeah.

Andrew Freeman (24:14.858)
reasons that were provided according to the data to HRA as to why they but there were some that weren't given reasons so there again we're talking about 40 50 studies where there were no reasons so so i think even in the registration side where the you know the metric might look good 94 percent there's still a quite a number of studies that aren't being transparent right and i think that matters

Maya Zlatanova (24:20.22)
Okay.

Maya Zlatanova (24:40.782)
Yeah. Of course.

Andrew Freeman (24:42.69)
know what are those studies? Are they phase three studies? Are they phase one studies? You know what are those studies? So somebody's doing a study with patients and it's not being transparent. I don't care whether it's one study or it's that we need it. So even 94 % for me isn't good enough and I also worry. So what some of the reasons that HRA cite is because the study wasn't considered to be a clinical trial.

Maya Zlatanova (24:56.314)
No, absolutely.

Andrew Freeman (25:11.49)
But why is that a reason not to be transparent? So if it wasn't a clinical trial, people are looking at the definition of a clinical trial and say, well, actually, my study doesn't fall into the definition of a clinical trial. Therefore, I don't need to be transparent. no, yes, you do, right? Just because your study doesn't meet the compliance definition of a clinical trial. You're still doing a study, presumably with patient data. So you should be transparent, right? You should.

Maya Zlatanova (25:35.398)
with patients, yeah.

Andrew Freeman (25:39.938)
absolutely register your study so that it can be followed through for publication so we've got the full evidence base etc etc. So I think that 94 % looks good now everybody does exams and goes well if I've got 94 % I'm good to go. Actually let's challenge that and then looking at the data a bit further I think it was only around 44 % of studies were published.

Maya Zlatanova (25:42.204)
Hmm.

Maya Zlatanova (26:01.874)
42 or 45, something like that. I think I read that, Yeah. Yeah, insane.

Andrew Freeman (26:08.258)
I mean that's even worse. What we're talking about 500, 600 studies weren't published. So why? What is happening there? I think that's extremely poor, but it's not unsurprising. So if you go back into the UK, think it was 2018, I could be wrong. There was a House of Commons Select Committee looking at clinical research transparency and they reported I think around about 50 % of studies weren't published.

Maya Zlatanova (26:13.645)
Yeah.

Maya Zlatanova (26:18.833)
Mmm.

Andrew Freeman (26:36.93)
So that kind of 50 % number hasn't changed since 2018 to 2024, which is why, of course, there's now regulations in the UK that you must register your study and you must post a summary of the results to the same registry. There's now legislation making you do that, right? Because historically, people doing it voluntarily hasn't worked.

Maya Zlatanova (26:39.41)
Yeah.

Andrew Freeman (27:06.818)
Now you come back to your question. Yeah. Yeah.

Maya Zlatanova (27:09.002)
Can I stop you here, Andrew, before that? Because this is very, very interesting. Thank you so much for sharing these steps. I was reading exactly the same in the regulation that you mentioned is, I think, awesome. Another example of the UK infrastructure getting better and better for both research, but also patients at the same time. And that's so, important. I just want to also pause here and explain why it's so critical for sharing the results.

to actually change, like the percentage of results that are being shared, for us to change this percentage, to make it higher. Basically, like a human being, we learn not only from the good lessons, but also from the failures, let's say. So even if a clinical trial fails or does not provide the results that we expect, this is still a know-how that everyone else actually can learn from. And I recently posted the...

Andrew Freeman (27:43.84)
Yeah.

Maya Zlatanova (28:06.5)
about Alzheimer's disease. There was this publication that became so popular and everyone started doing research exactly following these new trends. put it like that way. They put not only efforts, but huge amount of funding into that particular area. And nobody really shared that this is not.

going in the right direction. And so more and more companies and people are going after this trend until one moment of time, years and years later, realizing, we're actually in a, yeah, that's a dead end. And that's not the right direction. So that's why it's so critical for the results to actually be published. Because no matter what happened, no matter the results, they are critical know-how for the entire humanity and for the future of medicine at the end of the day.

Andrew Freeman (28:39.137)
Yeah.

Andrew Freeman (28:53.122)
Yeah, absolutely. And when you talk about medicines, it means that potentially there's not a complete evidence base around that medicine. Some of it isn't being published. And that leads to obviously publication bias and decisions being made on an incomplete evidence base, which is fundamentally wrong. OK, so I think that's really important. And it also is not published, then other researchers may duplicate the same research.

Maya Zlatanova (29:13.426)
Yeah.

Andrew Freeman (29:22.074)
wasted resources but also it patients at risk unnecessarily right because they're being recruited into a study that needn't have taken place so there's loads of reasons why results should be should be published but but but the kind of the the challenge is quite is more is multi-dimensional right so again when i was looking at studies for my father a few years ago

Maya Zlatanova (29:22.416)
Exactly.

Andrew Freeman (29:49.026)
and trying to access results of studies. So only half of them are published. Those that are published trying to access the results of those. And having worked in GSK, you used to go online, the library app on your desktop, click that, read the paper, not a problem. But of course, now I'm not a GSK and you click on a link to read a paper, oh, I need to pay 70 pounds or 80 pounds to read that paper, right? They're sitting behind a paywall.

So not only is only 50 % published, a certain proportion, I don't know how many, sit behind a paywall. So I know I'm going to pay 80 pounds every time I want to read a paper. And then when you get there, how many of those then are understandable to a general audience, right? So if you take that funnel, at the end of the day, the number of where they've got results that are available and understandable is probably quite small.

Maya Zlatanova (30:18.813)
Hmm.

Andrew Freeman (30:44.406)
And I think that's where this trust thing comes in that I referred to earlier. If through all of that research, only a small percentage is actually understandable, I think that undermines trust of the whole clinical research enterprise. And I think as a community, we should try and fix that as much as we

Maya Zlatanova (31:01.721)
Yeah, going back to my original question, where do you see the biggest resistance?

Andrew Freeman (31:03.882)
Yeah, sorry.

So this is kind of another kind of challenge. the new regulation relates to clinical trials and investigational medicines called CTIMS. And clinical trial investigational medicines, a lot of those are done by industry. having a, with an industry background, I know that with a regulation, industry will make sure they're compliant.

It's just what industry does. They're a very heavily regulated industry and they make sure they comply with the regulations. So I have every confidence that industry doing CTIMS will comply. I think it might be more of a challenge sometimes for academic institutions because they don't have that infrastructure that industry's got. Industry's got compliance functions, policy functions, we've got policy and process, they've got...

things to check to make sure it's being done, risk report, yeah, the whole gambit of tools and resources to make sure that regulations are complied with. I think maybe, I don't know, I've not got a history in academia, but that infrastructure may not be as robust in some academic institutions. I think the other challenge is, which relates to my point about looking at whether it's a clinical trial or not.

Maya Zlatanova (32:08.947)
Yeah.

Andrew Freeman (32:32.77)
is that the regulation relates to CTIMS. I think there's a risk that people will look at that and go, well, actually, my study is a clinical trial, but it's not a clinical trial of an investigational medicine, not a CTIM. Therefore, I don't need to be transparent. And I would argue, yes, you do, right? Just because it's not within the regulation and it's not, you know, within the definition of a clinical trial of investigational medicinal product.

Maya Zlatanova (32:45.586)
Mmm.

Andrew Freeman (33:00.322)
should still be transparent for the reasons that we've mentioned. So there is a kind of a danger that it's a compliance mindset that's applied. Let's look at what the regulation says, let's comply versus a transparency mindset, which says I'm doing a, I'm doing research with patients, it's a clinical trial, observational study. need to be transparent with this. I need to make sure it's registered. need to make sure that the results are posted. I need to make sure it's published and

I would argue I need to make sure the patient level vector is shared for other researchers. It doesn't matter whether it's outside the detail of the definition within a regulation. You should be doing it anyway. And so I think the danger that people will go, oh, it's not a CTM. It doesn't apply. But the ethics of it do apply. And I would encourage people to do it.

Maya Zlatanova (33:34.535)
Yeah.

Maya Zlatanova (33:47.953)
Yeah

Maya Zlatanova (33:53.205)
Yeah, but you were touching on something very sensitive, whether everyone will do what's right, basically, and whether society is built on what's right or what's forbidden, or what should be, like, yeah, you get what I'm saying. And this is actually the question if...

Andrew Freeman (34:08.534)
Thank

Maya Zlatanova (34:15.814)
If we know and if regulators know that companies will follow what the compliance is, why wouldn't they change the regulations so that it captures all the clinical trials? In my episode with Till Bruckner, mentioned an idea that I very much like. Don't get me wrong, I didn't go into details. Maybe there are some caveats that need to be considered. But for example, he mentioned that probably

let's say academia that gets funding for doing some sort of a research, why not actually being allowed to get a certain part of the funding only after publishing the results? Or you get funding for the next research only if you've published the results beforehand, for example. So I know that this is more like carrots or the stick type of situation. However, if we have such a horrible situation with less than 50 % of clinical trials,

providing transparency and sharing their results. And by the way, it's not just the results sharing. It's also sharing things like where the locations of these clinical trials are. I I know firsthand that there is a lot of resistance in sharing this information as well. So my point is that if compliance is the driving force, why wouldn't regulation actually captures all of these clinical trials and make it mandatory for all these people?

Andrew Freeman (35:41.674)
Yeah, good challenge. think the problem with regulation is that it's very difficult for it to evolve and develop, right? If it's voluntary and there's not a hard and fast regulation, it can evolve and develop over time. So, know, in the United States, obviously, they've got a regulation around registration results posting, which is very strict in terms of what it is you will post.

Maya Zlatanova (35:51.774)
Mm.

Andrew Freeman (36:09.742)
which is great on one side because it means that everybody has to do exactly that. The downside is that maybe there are things in there that shouldn't be there or things that should be there instead. But then it becomes very difficult to change and adapt it because then you have to go through the relationship process to get it changed or at least the guidance process. there are upsides and downsides. I just think that if you have the right mindset, the transparency mindset that I refer to,

Maya Zlatanova (36:19.207)
Hmm.

Andrew Freeman (36:39.51)
which is right for patients, it's right for science, it's right for evidence base. And I think people who do clinical research, think they have these core values anyway. And I just think it's just about trying to make it, as I started at Runeo ISRC GenStruxure, making it easy, right? If it's difficult, it won't be done. If it's hard, it won't be done. So what can we do to make it easy?

Maya Zlatanova (37:04.468)
Sure.

Andrew Freeman (37:08.322)
So again, you know, we've got links from health research authority systems into ISRC TN. So people don't have to key in the same information. I know you say, well, that's a small thing, but I think if you, these little small things can all add up. So it's that it becomes actually quite a straightforward thing to be able to be transparent with your study. And I just think you're right. There are things that you can do around fund that, know, funders can say, well, we're not going to fund your next piece of research.

unless we've seen a publication. I've been in meetings where bundles have said that is their policy. I don't know whether they're not following through with that. I have no idea. I think from my standpoint, I'm looking at this and saying, what can we do? What can we do as a registry to try and address our piece of the world, if you like? And that comes back to try and making it as easy as we can for people to register with process, reminders.

Maya Zlatanova (37:46.216)
Mmm.

Maya Zlatanova (37:51.015)
Yeah, of course.

Maya Zlatanova (37:56.115)
Mm-hmm.

Andrew Freeman (38:04.704)
and systems that help rather than hinder. And I'm sure we won't get it right all of the time. I'm sure that we need to develop our systems, that our results system is very complex in many ways because there are so many results fields. It's far more difficult to design something that captures results versus just capturing and protocol summary.

And I'm sure we need to develop and evolve that, but we want to work in partnership and then collaboratively with the research community such that they can be transparent and we can provide information that makes sense and is understandable. And I think there's a lot of shared objectives in that space that we can build.

Maya Zlatanova (38:50.461)
Andrew, I wonder, I completely agree with you that only relying on regulations will not do the job or it will do a problem, but probably it will take way more time, way more mistakes and so on and so forth. And we need to do...

something towards making it easier. And so the people with a transparency mindset, I just love this transparency mindset, like as a word, this is the thing that I'm going to take away from this episode, definitely. So let's say to the people with a transparency mindset, they will have one more, let's say one less excuse.

for not for why, why they should actually register both their clinical trials results and everything else basically. that's, that's really important. You mentioned that it's too, it still takes time, even with all your efforts to make it easy and so on and so forth. It's too, takes time. It's too not like completely effortless. I wonder, have you considered the whole world is speaking about AI agents and whatnot. So is that a topic now that you're building your

Andrew Freeman (39:50.55)
Yes.

Maya Zlatanova (39:54.697)
features and capabilities of the registry.

Andrew Freeman (39:57.891)
is certainly a topic that we've started to discuss and explore. Obviously, we've got a focus at the moment is around results disclosure. But certainly, there are huge opportunities, I believe, with utilizing AI technology. So for example, an AI technology could utilize what we have on ISRCTN as it's...

Maya Zlatanova (40:15.402)
Mm-hmm.

Andrew Freeman (40:27.2)
as its information source. And you could ask a plain language question, is there a study near me in Manchester looking at whatever condition I've got? The AI can probably provide that answer in a more patient friendly manner than trying to search through our keyword search and that way of things. So I think there's huge opportunities there. The kind of challenge is that it's kind of not

always 100 % correct and it can make things up, hallucinate or not get things absolutely right. But I think there's huge opportunity to use those technologies. I mean, even today, you know, I've got a question that I need to have answered. You know, what is the WHO requirement for X? I'll go on to chat.tpt or Claude, find the answer. I don't go to WHO website anymore. go to Claude or chat.tpt.

Maya Zlatanova (41:16.68)
Exactly, yeah.

Andrew Freeman (41:23.33)
And the answer's there and it's with context. And most of the time, in my experience, it's pretty accurate and they're getting better and better and better. so absolutely, I've been, absolutely is a huge advantage and opportunity at all to help engage the broader community in clinical research, whether that be patients, carers, or indeed the broader public. Right. So I'm always amazed, you know, there are, you know,

landmark studies in Nature and other scientific journals, but the public doesn't necessarily get to hear about them unless it's picked up by a particular journalist and it may not be reported that well. But I think there's lots of great science going on and I think, I've always thought that if it only be communicated in a way that's more engaging, more understandable to a general audience, you get more engagement in science generally, whether that's clinical research or basic science.

Maya Zlatanova (42:04.821)
Of course.

Andrew Freeman (42:22.242)
So I think AI can help unlock that, or be a key to unlock that.

Maya Zlatanova (42:26.42)
Yeah.

No, I agree. But for our audience, it's also important that actually your work, like to mention that your work on the clinical trial registry, transparency side of things becomes even more important because many people say dirty data in, dirty data out, basically, their insights out. I'm also using the chat GPT's and Clause and so on and so forth.

Andrew Freeman (42:47.328)
Yeah.

Maya Zlatanova (42:54.643)
I generally rely on the information there, but I also have to say that I have cases where I've been very much misled. Actually, it was recent with the very serious miscommunication brought to a governmental website, which actually turned out not to be governmental website. So yeah, I had some challenges with that. But my point is that that's why it's even more critical now to work on these registries to have the right data, complete data.

Andrew Freeman (43:01.986)
Yes.

Maya Zlatanova (43:24.149)
up to date data, because if that's not the case, no matter what type of AI layer you put onto your platform, or you just using, let's say, cloud or a charged PT, you will be misled and will maybe be even more challenged with awareness and the reliability.

Andrew Freeman (43:42.486)
Yeah, that's the downside.

Andrew Freeman (43:46.753)
Yeah, but that's the downside. The upside is, you I think as you're probably aware, it is quite hard to write up your study in a way that's generally understandable for an audience. It is a hard, you know, and particularly if researchers and scientists are not used to doing that kind of communication or trying to do that. It is a hard thing to do. It's not easy at all. And I just think if you've got some data or a scientific paper and put it into Jack GPT or Claude to say,

Maya Zlatanova (43:59.767)
True. Yeah.

Andrew Freeman (44:15.926)
make this understandable. gives you a huge start. Absolutely you have to check it. Absolutely you need to develop it. But it gives you a huge start rather than you're looking at a blank screen and a cursor, you know, flicking at you thinking how on earth am I going to do this? So I do think they are huge. You're right. You need to use them in the right way. But I think they are used in the right way are a huge advantageous tool.

Maya Zlatanova (44:20.766)
Yeah

Maya Zlatanova (44:25.33)
absolutely.

Maya Zlatanova (44:40.958)
And I can continue speaking with you forever. However, we're out of time. So I have one last question to wrap up and summarize your perspective on the topic. If there is one thing you could change about the industry's perspective on clinical trial transparency, and not just perspective, but the whole industry's approach towards clinical trial transparency, what would that be?

Andrew Freeman (44:44.802)
Okay.

Andrew Freeman (45:08.162)
Do you mean the pharmaceutical industry?

Maya Zlatanova (45:10.44)
In general, like clinical research industry, not just pharmaceutical, but also like academia, everyone that's involved in.

Andrew Freeman (45:14.306)
It's a bit of a cliche I'm afraid, but it is focus on the patient because if you focus on the patient around what the patient wants and needs both into the trial and outside the trial, transparency will flow from that right. So I know the focus on the patient is kind of a bit a cliche and everybody will raise their eyebrows but actually...

Maya Zlatanova (45:25.728)
Mm.

Maya Zlatanova (45:35.286)
It's no brainer.

Andrew Freeman (45:43.144)
actually if you do that you won't go far wrong and if you have that focus with that transparency mindset that we've got you'll get you know I think the world will be a better place hopefully in terms of clinical research transparency anyway.

Maya Zlatanova (46:00.896)
Thank you, Andrew. And thank you for all the work that you're doing. My final words for the audience is make sure that we all have a transparency mindset, like Andrew said. At the end of the day, we're doing it also for ourselves, because if there is no transparency, there is no trust in clinical research, and there is no progress in clinical research in medicine. So we all need the transparency mindset. Thank you, Andrew, once again.

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