This is our discussion with Lydia Ainsworth which was recorded for the Solutions OP Clinical Trials podcast. You can listen to the original recording here. Please note that the discussion below is adapted and not a transcript. This was done to improve readability.
Olga: Welcome to today’s episode of the podcast. Today we’re going to discuss a conference attended with my colleague, Lydia Ainsworth. She’s our Senior Clinical Data Quality Manager.
We attended a conference in Birmingham on the 13th and 14th of April 2026, organised by the Institute of Clinical Research. It was a regulatory conference that informed us about changes to UK regulations. There were representatives from the ethics committee, the HRA, the MHRA, and other regulators, as well as vendors from various commercial companies who attended the meeting.
It was a very productive two-day meeting, so I attended the first day and will cover the first day’s topics, and my colleague Lydia will cover the second day, which she attended. It was a very good meeting, so if you want to learn about the changes and what’s going on in the UK, I think it’s really worth listening to this podcast. It will help you a lot.
The first day was more of a meeting with the regulators, and we had attendance from the MHRA and HRA. We talked about patient involvement, and the MHRA’s remit was not only about drugs but also about medical devices, which was very interesting. It was like a combined session where we could hear about both, not just drugs but medical devices too.
The main thing that happened in the UK is that, as of 28th of April 2026, we have a new clinical trials regulation. That was the main topic of discussion for the MHRA about drug studies, because the regulation affects predominantly drug studies but also medical devices.
The first session was a panel discussion about AI and its use in clinical research. It was attended by an MHA representative and some people from private companies and CROs. They discussed AI and how it is increasingly used in clinical research. As you might know, regulators are very keen on using AI to streamline the review process for clinical trial applications. The FDA has already implemented this. They’re using AI to review applications, and the MHRA is doing something similar here in the UK.
Of course, those who work in the private sector, like CROs, big CROs, are also very keen on the ability to use AI to reduce resources and streamline the process. Now, when it comes to hospitals, it’s a bit more complicated because some hospitals in the UK use electronic medical records, but some still use paper, so that’s a bit of a tricky one.
And here I’ll ask Lydia to join me, so I don’t bore you with my own things. Lydia, what is your takeaway from the AI discussion? Maybe about how that could impact the sites, given your experience. You worked with hospitals all the time and reviewed source data, so what is your opinion about AI as an application in clinical research, using the data?
Lydia: I think one of the things that I found interesting was how they talked about the use of AI for task automation, things like doing quality checks, which obviously is very relevant to what we do. But when considering how it’s going to be used for that, I think you’ll always have to remain cautious, as they’ve covered. It’s just something to remember that AI can’t do everything perfectly all the time. We know it can hallucinate, so it can confidently put out a false output, and that could be quite dangerous if it’s doing quality checks, particularly for information that has implications for patient safety.
So I think even if we are going to see more AI used in clinical trials, human insight will always be needed at some stages, particularly for those quality checks. I don’t think humans will be completely replaced by AI, at least not any time soon.
Another thing they mentioned, which we also discussed in our last podcast, is that we may see more use of in-silico models that use AI to predict biological processes and drug interactions. There’s a push to do that a lot more, because we can use that instead of testing on animals, which is obviously cheaper and more viable. I think we’re going to see it used in more areas like that, but in other areas it might take a little bit longer because there are extra considerations. I’m not sure what you thought.
Olga: That’s absolutely right. I agree with you. In-silico models, that is something that everyone is very keen on at the moment. It’s not only in the UK but also with the US FDA. They’re very keen on that, and even the European Medicines Agency is moving in that direction. So we’ll probably see some guidance coming from them on this.
Yeah, indeed, we can use it for quality checks, but I think that was also my impression from the regulators. MHRA also think that we still need someone to do the quality check, so it’s not going to be just AI doing everything for us while we drink our tea, which will be very nice, actually.
For now, you won’t be able to just drink your tea. I’m afraid you’ll still have to do some work. So, those were the key points from the AI session. Of course, this is a very dynamic field, and I’m sure we’ll see a lot more development in the near future.
The next important discussion on that day was about medical devices. For those who are not familiar, there is an ongoing consultation between the UK and the USA on a recognition procedure for medical devices, which I was particularly interested in. The idea is that, if they reach an agreement, medical devices approved in the USA will be able to be used in the UK healthcare system.
And that’s great news because it will increase the number of medical devices we can use, so that’s a really positive thing. I’m really looking forward to learning more about this, so my question to the MHRA representative was whether there were any updates.
My understanding from what he said is that they’re looking more at post-market considerations rather than pre-clinical. Basically, if you have a medical device already approved in the US by the FDA, that recognition procedure could be used to bring it to the UK, but from what he said, we don’t believe this will include devices that aren’t FDA-approved at this point.
If you have a clinical trial in the US and that clinical investigation is approved there, it doesn’t automatically transfer to approval in the UK. At this point, because the review processes in the US and the UK are different, they’re just discussing post-market arrangements for devices that are already approved and on the market.
Another very important topic here was the amendment fees. The current amendment fee is £343 for each amendment we submit to MHRA, and we’ve been informed that this fee is now scrapped, which is great news. When you make changes to your protocol and other documents, you have to submit an amendment, and you have to pay a fee each time. The fact that they’ve scrapped these fees is really great news, particularly for smaller companies and startups, where the budget is quite limited, so all these fees will have an effect.
Another important point from the medical device presentation was about opportunities to obtain a waiver of the set-up fees for regulatory purposes with the MHRA. If you have a start-up company and you’re looking to set up your first clinical trial in the UK, and you’re a UK-based company, then you can apply for a waiver, and these regulatory fees for the review will be waived.
At the time of the conference, when we were discussing this, there was ongoing debate about whether it was worth keeping the fee waiver scheme, but I later discovered that it had been extended for at least another year, and possibly longer.
So it’s like a pilot, they’re trying to see how that works, and while there’s an argument for many small companies. They include regulatory fees in their budget when they raise funding. The problem is that you don’t always get the full funding you need, so, if you can save something from somewhere and invest it more in the manufacturing of your device, of course that’s always welcome. So we’ll see how that goes, but that was very positive feedback and a very positive review of what’s happening in the medical devices.
The next presentation was about clinical trials for drugs from the HRA and MHRA, and I’m going to merge the two sessions together because they were linked. One of the key metrics in the UK at the moment is to set up clinical trials within 150 days. When we say 150 days, we mean from the submission of the clinical trial until we have the first patient in the trial. That’s what they’re aiming to do, reduce the set-up time to 150 days. And very interestingly, I just read this morning that they’ve managed to reduce that set-up time to 122 days in some studies, which is really positive. This is really good news. So, as much as we can reduce the set-up time, of course that’s brilliant, and we should work to achieve this.
The other important update was about the new clinical trial regulation, specifically the distinction between notifiable and non-notifiable clinical trials. I saw it in my updates today. MHRA has released a new checklist to help people decide whether their trial is notifiable or not. What’s different in the new regulation is that some clinical trials are not notifiable. So, if you have a drug already approved on the market and you’re using it within its indication, it’s basically a post-marketing study, so you don’t need approval from MHRA. You can just go to the ethics committee.
So, in a similar case, if you have a drug that is approved and on the market, but you’re using it for a different indication that is not approved, and you have data available to support that it’s safe, even from the literature, then you may still avoid having to submit to the MHRA.
The third case is about clinical trials, which are approved by the European Medicines Agency and the US FDA. So basically, if you have a clinical trial which is approved by the European Medicines Agency, and all the documents, the protocol, and everything are the same, and you submit it, then you won’t need to get approval from the MHRA.
And it’s the same with the FDA, with that difference, because there are some documents which are different between the UK and the FDA. So in the UK, we have an Investigational Medicinal Product Dossier (IMPD), which is not applicable to the FDA. So what they’re saying is that if your clinical trial is approved by the US FDA, the protocol is the same, and the manufacturing of the drug is the same, then you might be able to continue without having to submit to the MHRA for approval.
This is some kind of recognition procedure between the different regulators, which I think is fantastic news, and it could reduce the overall setup of clinical trials if you don’t have to go through the MHRA and do all that. So that was a very important update.
In terms of approval metrics, MHRA provided very interesting insight into their latest approval metrics for clinical trials, which have been reduced to 50 days. According to the regulation, the timeline for approving new clinical trials in the UK is 60 days, and their metrics show that the average approval time is about 50 days, which is really good. So they’re a lot quicker than they expected.
Another few things I want to mention here are the joint scientific advice between the UK MHRA and NICE. For those who don’t know, NICE is the price regulator in the UK. They offer this new scientific advice, so if you’re looking to place your drug on the market in the UK and you don’t yet have marketing authorisation, you can submit in parallel to the MHRA and to NICE, which is the price regulator.
And you not only get your drug approved, but you also agree on the cost of this drug, and you can get it to patients more quickly, so they have access to it. The idea is that once it’s approved by MHRA and NICE together, you can basically place it directly on the market, which is brilliant news, and it will be covered by the healthcare system in the UK. Now that is a tricky one because it requires a lot of resources to be able to do that, including the submission to the agencies, so maybe not really suitable for small companies, but for big companies, that’s definitely something they can explore.
Another important update was about the recognition procedure with Singapore. If you have drugs approved in Singapore, there’s a fast-track process for these drugs to be approved in the UK as well. This is a new process and involves collaboration between the UK MHRA and the regulators in Singapore. So that’s another important point, particularly for those who have drugs developed in Asia and want to bring them to the European market, including the UK.
Feasibility services were another topic discussed. Here, we have a streamlined feasibility process. It’s a system where you submit the information, including the types of sites you need. We provide a draft or blinded protocol, and then there’s a centralised system and service that provides you with sites and hospitals that are interested in conducting the clinical trial. It’s a free service, and it works quite well. We’re using it regularly. Of course, it depends on hospital capacity. Sometimes it can take longer to get responses, but if you have to contact hospitals on your own, you’re not going to get them any quicker. I can promise that.
The last 3 sessions on that first day were about patient involvement. We had 3 different presenters. They discussed involving patients in the design of clinical trials, the importance of considering patients’ lifestyles and many other factors when designing clinical trials, in a way that supports not only participation in the clinical trial but also retention, so that they can be treated long term.
And here, I’ll leave it to Lydia to say a few words on patient involvement and her takeaway from this session.
Lydia: I think it’s great to see that the regulators are pushing for greater inclusion and diversity in trial design, and also in the regulations that govern the trials themselves.
And I think, overall, the focus on patient involvement is creating better-designed trials because they’re being designed much more efficiently and recruitment has increased, as patient experiences are taken into account. On the flip side of that, the trials are actually becoming a more positive experience for participants, which is something they talked about as well.
Another thing they discussed was how people-centred research is being extended to research involving staff, particularly at NHS sites, and that’s helping to improve research, because understanding their perspectives can also help run trials much better, including how staff work around trial protocols and things like that.
And I think the patient-centred aspect was reflected in the talk that followed, which was about the psychology of joining the trial and the decision funnel. So that covered all the factors that come into a patient’s decision about whether to take part in the trial, and I think without that understanding, we wouldn’t really have the practical tools that the sites are applying to improve trial recruitment. So it really emphasises the importance of trial design that’s centred on the patient, and of having that insight.
Olga: Yeah, exactly, we definitely need the involvement of patients in designing good protocols, but I think we also need to understand that sometimes the regulators want a specific type of data, so that’s something we cannot avoid, and that’s something that creates complexities in all clinical trials.
Even though we try our very best to make them acceptable and workable for patients, sometimes we have to consider what is required from a regulatory point of view. Well, of course, you can always improve your design and avoid having pharmacokinetics (PK) samples on Sunday, for example, right?
So we can think of those kinds of details to make it easier for patients and for nurses collecting samples and things like that. There’s definitely room for improvement on this. But patients’ involvement is important, and providing feedback to patients at the end of the clinical trial with the results is also very important.
The final session of the day was a roundtable discussion. I found it quite interesting, with a few discussions across the different tables. I was involved in the discussion on how to improve the clinical trial setup. Lydia was talking about the trial master file and how to make things digital.
Now, I’m not going to go into all these topics because it would be a never-ending rant, so I’ll just stay away from them. We might record a separate episode just to discuss the roundtable discussions, our feedback, and what we think could be improved, but for the moment I’ll just leave them like that.
That was my first day. I’ll leave it to you, Lydia, to talk about the second day, which was also very interesting, from what I saw on the agenda. So, Lydia, over to you.
Lydia: Yeah, I attended the 2nd day of the conference as well. The 2nd day started with a talk about digital innovation in Alzheimer’s disease, focusing on patient electronic medical records and how access to anonymised records can be used for research. But this is limited by a lack of standardisation in the records. Because there’s not much consensus across sites on how patient information is recorded, it can be really difficult to extract and use that data. This is something that we see very regularly in the monitoring aspect of our job.
One of the solutions they suggested for this was to use an AI model, specifically a natural language processing model, to interpret the medical records and extract and code specific symptoms. In relation to Alzheimer’s disease, this involved using health scores and symptoms to extract keywords, and recording any treatments given for mild cognitive impairment, which is the precursor to Alzheimer’s.
These kinds of models have the potential to extract large amounts of data and perform large-scale, robust analysis, while also reducing the site burden of conducting all the screening procedures and collecting the data. It sounded very promising.
The next talk after that was about the Our Future Health project. This is an early detection and prevention research project aimed at recruiting 5 million people, and I’m sure many people have heard of it. I’ve had letters through the door about recruiting, trying to recruit people for it.
This consists of baseline screening questionnaires about lifestyles and demographics, followed by a blood test to collect genotype data. It’s a large collaborative project between the NHS charities and private companies. The company conducting the genetic analysis is Biogen, and they’re the one being collaborated with. Obviously, it’s collecting a lot of health research data, and it also provides participants with genetic and non-genetic risk information, based on the information they give as part of the trial. It also gives them the opportunity to be recalled for future research projects they might be eligible for.
The talk was really interesting because they already have a really impressive cohort of data, even though they haven’t finished collecting or recruiting all the patients yet. It has pretty good diversity across age, gender, ethnicity, and income, so all those background factors. It seems like the research they’re going to do is probably quite applicable, if not generalisable, and it sounds like it’s going to be the foundation of a lot of future research projects and really help connect researchers with participants.
For example, identifying people who might be at high risk of rare diseases based on genetic data, and helping to find treatments and look at outcomes for those rare diseases, is obviously something that’s super important because those trials can be really hard to recruit, so if they’ve already got that information on file, that can make that a lot easier.
Olga: Yeah, if I can add something here, this is something the FDA is also very keen on. I read recently that they are looking to have some kind of database or information that they can use, particularly for rare diseases, because it’s so hard to find these patients. It can take years if you have to recruit them in a standard clinical trial, so that could give them an additional option.
If they can access that data, analyse it, and use it to help them understand the disease better, and then use that data in silicon models as well, it’s really critical and important. Sorry to interrupt you.
Lydia: No, it’s fine. That actually leads nicely into the talk that followed, which was about identifying precision cohorts using AI, using that genetic data and applying AI models to identify abnormalities or characterised disease. I feel like those two things are very linked to being used in conjunction with AI.
It seems necessarily feasible that they’re doing it on a large scale, so I think the kind of projects that are using precision cohorts are going to be used, kind of on a small scale, by the sounds of it. It seemed like they were only going to be recruiting people who would benefit from being identified as part of those cohorts, so, for example, if they’re experiencing a lot of symptoms from a rare disease, further genetic testing might provide more insight to help manage those symptoms. So it doesn’t seem like it’s going to be rolled out on a large scale, in terms of the AI applications.
Olga: That’s very interesting, and I think this is something that many other regions around the world are keen to collect that data and be able to do this analysis, potentially identifying patients for new treatments and so on.
So I think having that data is important, and AI could be beneficial here if you have the correct model. You can definitely achieve some very interesting results and have the opportunity to learn more about particularly rare diseases.
Lydia: It’ll be interesting to see how these areas of research crop up more and more in the future, for sure.
The talk after this was about the digitalisation of the site, which was also discussed briefly on the first day. It was about a collaborative project run by the NHS between the University Hospital Southampton and the University Hospitals of Leicester. It focused on the electronic investigator site file and the benefits of implementing it over paper investigator site files (ISFs), which again is something that we deal with a lot in our job.
Some of the main benefits they talked about included improved regulatory compliance and audit readiness, such as having automated systems that might flag if something’s missing, or having something that implements a standardised structure so that you can make sure all of the necessary documents are there.
Another benefit was having a unified system, which makes collaboration between sites and sponsors easier, so everyone can have access to one file in an electronic space. This is part of an ongoing plan within the NHS to digitalise many of its processes, so it’s promising to hear that this is happening, even if it seems to be happening slowly.
At least from our perspective, digital trial documents have many advantages over paper and tend to be easier to use. We always seem to prefer or nudge sponsors towards electronic versions of files, which particularly makes things easier for remote monitoring, for our job anyway. It’s reassuring to hear that the NHS is moving in that direction.
And one concern about this, which I think somebody asked about in the question session at the end, was the security of data when you’re storing it in an electronic environment. This was touched on in the next talk that followed, which was about secure data environments.
Data security is crucial for protecting patient confidentiality, complying with regulations, safeguarding data, and maintaining data integrity. These measures are all required for clinical trials to be Good Clinical Practice (GCP) and General Data Protection Regulation (GDPR) compliant. So data environment security comes into all different aspects and stages of the trials.
For example, you might have physical security measures at the sites, such as locked cabinets and similar measures for physical records, and you also have cybersecurity practices for storing electronic data. So that would have to be implemented for the electronic site file.
And some of the discussion was from a CRO perspective, which was obviously really interesting to see how monitors view data security and the kinds of issues they come across at the sites when they’re doing monitoring.
Some of the high-risk scenarios that they recommended CROs look out for, which I thought were interesting takeaways from this, included sites using invalidated tools or spreadsheets, using unsecured shared drives to store files, a heavy focus on paper source documents because they’re not always safe in digital documents, and treating audit trails as only an IT concern, when, in fact, they should be monitored by monitors and other site staff as well.
Another thing to look out for is the use of shared logins or passwords on sites. They said this is particularly an issue when the team is really small. That’s something for us to look out for as well. We should make sure everyone’s using their assigned login to keep data secure and ensure that people who shouldn’t have access to the data aren’t accessing it.
Olga: I completely agree that US hospitals are way ahead of us. They use electronic site files. It’s basically a system like SharePoint, where you can drop the documents and they have access to them.
We don’t have that in the UK, unfortunately. In many cases, the sponsor has to provide access to the sites, and then they take the documents and store them on an internal network, and so on. So it’s a bit messy, I have to say.
But if you think about it, all our documents used in clinical trials are electronic. So we don’t have anything on paper. If we have a paper site file, we need to print things to file them, so they’re not in their normal state. Their normal state is electronic. We have to print them specifically for the site file. But that’s been a challenge, I understand the concerns about security and so on.
In terms of patient informed consent, I’m more in favour of keeping these on paper. It makes sense to keep them on paper at the hospital rather than scanning them and putting them in the side file. It’s different if you have electronic informed consent; then it’s apparently stored in some system somewhere.
I’m generally a big fan of the idea that we move towards using electronic files, where people have access to them, rather than going to look for papers somewhere stored in some cupboard, under someone’s desk and so on. And unfortunately, with paper, it’s quite tricky because you can lose it.
Lydia: I’m glad that’s been prioritised because it can obviously have so many documents. When it’s paper-based, it causes all kinds of issues if things go missing, or even when you’re working at the sites. If you’re sent to go and get something from a site file, that can take quite a lot of time, if you have to go and find the file, and then find the specific one, as there are sometimes 7 site files for one trial, and then actually go through and find the document, if it’s even there.
So I think having everything on an electronic system would be easier, and I’m sure a lot of people would agree with that.
Olga: And someone always has a small, tiny folder somewhere on their desk where they keep things, and they’re not actually filed, we know that story.
Lydia: Yeah, definitely. The next talk was about the updated GCP guidelines as of last year, the ICH E6(R3). This talk focused on updates related to risk proportionality in clinical trial practice. This means using a risk-based approach to designing, planning, and conducting clinical trials. It involves identifying factors that are important for trial quality, the risks associated with them, and then implementing or premeditating the risk mitigation strategies needed, keeping these proportionate to the importance of the data being collected, participants’ safety, and the reliability of the results. So, in practice, this might involve dissecting protocols and identifying the factors within them that are critical to trial quality.
As we know, data is often one of the key factors that has played a big part in the quality of the trial. But there might also be other factors that tend to differ across trials. So the assessment of risk has to be done on a case-by-case basis. It’s not a one-size-fits-all. It’s also a continuous process that needs to be practised across all trial searches, not just in the trial design. It should also be ongoing throughout the trial and during the close-out process, as we gain more information.
So this might look like implementing a monitoring plan with full source data verification, rather than a targeted review, so it’s not 100% source data verification (SDV). It would focus only on the safety data that’s important for what that trial is trying to investigate, and on the risks to patients.
I think overall, it seems like something we’ve already seen implemented in trials. I mean, you would obviously hope that, when the focus is on patient safety, these things are considered. But I think it is also good that the guidelines have been updated to emphasise this to make sure it is considered when trials are being designed and conducted, and to clarify what risk mitigation should look like.
Olga: We don’t have constant battles: ‘Why are you doing this?’, answer – ‘Because I think it’s important.’ and then ‘Well, no, you don’t have to do everything.’. I think we have to move away from this or interrupt this type of thinking that you need to do 100% of the 100%.
We need to really think about what is critical for the clinical trial. This is something that the regulators have been talking about for a long time, like the MHRA, which has been discussing this topic for a long time. They tell people that, if you’re doing a PK sample study, your priority data will be the PK samples, and they’re collected at specific time points, so that’s what you need to monitor. So other things which might not necessarily be relevant don’t need that much time from you.
This is what they’ve been saying, but now it’s really good that this is part of the ICH and GCP, and if someone comes back to you, you can tell them that you’ve done the risk assessment: ‘I can do it this way because I think that’s very important.’. In the past, with the old form, you could be challenged. They could say that GCP says you have to do 100% of everything. So, from that point of view, I think it’s very important that we have this update, as it gives us a lot more flexibility.
Lydia: Yeah, definitely. It seems like it’s going to help improve the efficiency of trials, while keeping the focus on the patient’s safety and acknowledging that, obviously, not all trials are the same, so risk mitigation shouldn’t be treated the same across the board. And it should really be based on what the trial is looking at.
Finally, on the 2nd day, the last talk was about the responsible use of AI, which is obviously very relevant given what we’ve discussed already. AI came up in many of the questions and in many of the talks across the two days, so it was a nice way to finish.
They started talking about some of the uses of AI in clinical research, which I’m not going to repeat because we’ve already discussed some of that. But interestingly, they also talked about some of the regulations across GCP, as well as the European Medicines Agency and the FDA guidelines on the use of AI in clinical research.
So, things like, if you are going to use AI and show that procedures within the trials are human-centric, adapt the use of AI to fit participant characteristics and trial design, and establish the credibility of an AI model in the context in which it’s being used in the trial. Ultimately, they emphasise that the investigator, if AI is being used at the site as part of the trials, is still responsible for maintaining oversight of the use of AI in trial activities, as they would be for any human activities, for any staff at the site.
I think the investigator and anyone using it are advised to be very vigilant about things like bias and hallucinations, because it’s not 100% correct all the time, and we can’t take everything it says as gospel.
Another good thing they talked about was practical tips. So, it’s all well and good having these regulations and recommendations, but giving people guidance on how to actually implement them was really helpful.
Some of the tips they gave included having an expert review all AI-suggested designs, declaring where AI is used, particularly for maintaining records and using AI processes. If you’re using something like a language model such as ChatGPT, using counterfactual prompts, so asking things like what the limitations of the findings are, and things like that, so you’re kind of challenging it and not just using it to spit out facts. It’s kind of encouraging you to also think about the other side of things as well. It was really refreshing to hear them talk about some of the limitations of AI, because the overall view of it over the two days was very positive, and to talk about how to address those limitations practically.
I think AI is sometimes seen as a kind of magical technology that can solve everything, without considering some of the risks of relying on it too much. But I think that when people were singing AI’s praises, we were being a bit more realistic about it, so it was nice to see that acknowledged in this talk at the end.
Olga: I think it’s very important to remember this, because I also use ChatGPT sometimes when I need information. Recently, I needed some information about import and so on, and I used ChatGPT, which provided some information for me. When I asked for the links to the sources, it turned out they were from regulations that had been withdrawn. If I didn’t ask for the links and didn’t check, I could have just assumed that the information sent to me was correct. I think that’s a very good example to show that you actually need to check. You can’t just 100% rely on something.
The other thing is, I think physicians will really like to take responsibility for AI designing the protocols. I think they’ll be very keen on that one. I would imagine that physicians would want to make sure, because when you’re designing the protocol, it’s very critical that you design it according to the standard of care of the country. It’s not just simply using literature or whatever’s online, but really knowing what the standard of care is and what is done in clinical practice, so you definitely need a physician or other people who are involved in treating patients to look into this and say, ‘OK, this is workable, this is what we’re doing in our clinic.’. That’s one of the biggest challenges. People design some protocols that no one can follow. If they’re not aligned with clinical practice, it’s really difficult to recruit patients and to produce any reliable data.
So I think that was a really good overview of this conference, and we’ve learned a lot from it. It was very interesting to attend. Thank you, Lydia, for your time, your input, and your discussion, and thank you to our listeners.
