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Why Bringing The Trial To The Patient Beats Dragging Patients To Sites · Lab to Lives

• 0:00
  SPEAKER_00: Welcome to another episode of Transformation and Trials.
• 0:02
  SPEAKER_00: Today we're going to dive into the topic of patient recruitment in clinical trials.
• 0:06
  SPEAKER_00: And with me in the studio I have Caroline Potts.
• 0:09
  SPEAKER_00: Welcome, Caroline.
• 0:10
  SPEAKER_00: Thank you, Ivana.
• 0:11
  SPEAKER_00: Caroline, could you uh introduce yourself briefly to my listeners?
• 0:15
  SPEAKER_01: Absolutely.
• 0:16
  SPEAKER_01: So hi everyone.
• 0:17
  SPEAKER_01: As Ivana says, I am Caroline Potts.
• 0:19
  SPEAKER_01: I am the general manager of all things site and patient services, and I work at the MRN, which is the medical research network.
• 0:29
  SPEAKER_01: Awesome.
• 0:29
  SPEAKER_01: And where are you today, Caroline?
• 0:31
  SPEAKER_01: I am.
• 0:32
  SPEAKER_01: If you imagine a map of the United Kingdom, you have Scotland at the top.
• 0:38
  SPEAKER_01: I am just below the border with Scotland.
• 0:41
  SPEAKER_01: So I'm in the northeast of England in Northumberland.
• 0:44
  SPEAKER_00: Awesome.
• 0:44
  SPEAKER_00: Well, today I am in Copenhagen in Denmark.
• 0:47
  SPEAKER_01: Beautiful.
• 0:48
  SPEAKER_00: Setting the stage for the topic today, could you tell us more about which role a trial site plays in clinical research?
• 0:55
  SPEAKER_01: Yeah, I mean trial sites are very much at the heart of clinical trials, along with patients, but it's still, I think, rare that you have patients without a trial site being involved.
• 1:07
  SPEAKER_01: So the the trial site itself is is usually where the activity is centered.
• 1:13
  SPEAKER_01: So that is the same the world over.
• 1:15
  SPEAKER_01: I think that sometimes there are differences in different geographical regions.
• 1:19
  SPEAKER_01: But I think that that holds true regardless of which geography you are in.
• 1:23
  SPEAKER_01: So whether you're in Europe, whether you're in the UK, whether you're in the US, the trial site is very much the beating heart of clinical trials.
• 1:32
  SPEAKER_01: It's not always easy to be a trial site.
• 1:34
  SPEAKER_01: I think the the pressures are many, and we might talk a little bit about that.
• 1:38
  SPEAKER_01: But regardless of that, the the trial site really is the jewel in the crown.
• 1:43
  SPEAKER_01: Absolutely.
• 1:43
  SPEAKER_01: And how are patients recruited into a clinical trial?
• 1:47
  SPEAKER_01: That can happen in lots of different ways.
• 1:49
  SPEAKER_01: Sometimes what you will find at a trial site is that you have a principal investigator, you have a doctor at the site who is interested in clinical research.
• 2:00
  SPEAKER_01: They will check through their patient databases to see if there are patients who are suitable to be approached to discuss the opportunity to go into a clinical trial.
• 2:11
  SPEAKER_01: Sometimes their advertisement campaigns that are run direct from the clinical trial sponsor or the CRO, and there will be campaigns on social media asking people if they have a certain condition, have you considered taking part in a clinical trial?
• 2:28
  SPEAKER_01: And there will be a little bit of information as part of that advert to help patients decide if they they want to take part or be considered for taking part in the study.
• 2:38
  SPEAKER_01: There are organizations and advocacy groups who advocate on behalf of patients who are also approached, usually by a sponsor or a CRO, to again just make it known that trials are available.
• 2:51
  SPEAKER_01: And I think what we're increasingly seeing is that there are platforms and portals available, usually disease specific, but not always, where a person such as myself or you would be able to search for a trial that they might be interested in.
• 3:06
  SPEAKER_00: Yeah, it does seem like the brokerage between trials and patient recruitments is an area in the rise and more and more solutions are showing up in this space.
• 3:16
  SPEAKER_01: Definitely.
• 3:17
  SPEAKER_01: Of course, we'd never get through the interview if I didn't mention everyone's favorite toy at the moment, AI.
• 3:22
  SPEAKER_01: And AI is very much starting to help us understand where patients with a certain condition might be.
• 3:29
  SPEAKER_01: I think a lot of that is still to be tested, to be really tested, to see how sensitive, how specific the AI mapping can be.
• 3:38
  SPEAKER_01: I think that, you know, in the not too distant future, we will see that become a very prevalent way of identifying patients.
• 3:45
  SPEAKER_00: That'll be interesting to see where that evolves.
• 3:47
  SPEAKER_00: And like what the final form of that trend is.
• 3:50
  SPEAKER_01: Yes, yes, definitely.
• 3:51
  SPEAKER_01: I think many are ch are in the race, but I'm not sure that anyone's got over the finish line yet.
• 3:56
  SPEAKER_00: Well, we have the trial site and we have uh patients who for a clinical trial need to uh visit the trial sites to participate in uh in tests and so on.
• 4:06
  SPEAKER_00: But what are some of the challenges with having patients visit trial sites?
• 4:10
  SPEAKER_01: Yeah, I think that if you have a person who perhaps has complex health needs or has a number of medical conditions, chances are that they have quite close interaction with a number of clinical teams and are perhaps more used to going to a trial site to interact with their clinician.
• 4:29
  SPEAKER_01: However, that's not always the case because a lot of trials you might be looking to recruit from what we call a working well population.
• 4:37
  SPEAKER_01: So the population themselves could have jobs, they have other commitments, they might be at school or at college.
• 4:43
  SPEAKER_01: It's not always easy just to step away from that environment to go to a trial site.
• 4:49
  SPEAKER_01: And sometimes it's a conversation that myself and my colleagues have from time to time with trial sponsors about in the protocol, the schedule of events will have that a physical exam is required as part of each protocol visit.
• 5:03
  SPEAKER_01: Is it really though?
• 5:04
  SPEAKER_01: Do you really need to do a physical exam?
• 5:07
  SPEAKER_01: Because automatically what that means is that there's a higher chance that your person has to come into the trial site in order for those things to be done.
• 5:15
  SPEAKER_01: Now, at MRN, we are not the only company that does this, but we are designed to be able to see a person in their home if it's safe and if it's suitable for trial activity to be done in a home environment.
• 5:28
  SPEAKER_01: And honestly, Ivana, I think that that's what we need to embrace more.
• 5:32
  SPEAKER_01: We need to embrace going to where the patient is, whether that's be in their work environment, whether certainly across Europe at this time of year we see people going to a holiday home.
• 5:43
  SPEAKER_01: That shouldn't stop them being part of a clinical trial or missing their trial visit.
• 5:48
  SPEAKER_01: We should be able to see that individual where they are for that length of time.
• 5:53
  SPEAKER_01: So sometimes it's not the the trial site's problem and it's not their issue, but still I think as an industry there is a desire to bring patients to a location for their trial activity rather than taking the activity to where the patient is.
• 6:08
  SPEAKER_01: And I think that sometimes is the biggest problem, the time commitment, the visit schedule.
• 6:13
  SPEAKER_01: And that doesn't always marry with the person's life and their work and their other commitments, as I say.
• 6:19
  SPEAKER_00: What would they look like in practice if you can say the trial comes to you in your home or in your workplace or in your holiday home?
• 6:26
  SPEAKER_00: What sort of equipment it would be necessary to bring?
• 6:28
  SPEAKER_00: And also like what does that require from the person bringing the trial to the patient?
• 6:33
  SPEAKER_01: There are obviously some deal breakers.
• 6:35
  SPEAKER_01: You can't scan a patient or do any kind of x-rays or anything.
• 6:39
  SPEAKER_01: But what you can do, if it's a standard blood draw visit, even if it's an IMP visit, the IMP can more often than not, not always, but more often than not, can be done in a home environment or a work environment.
• 6:54
  SPEAKER_01: Now, if it's a work environment, we don't just sneak in and hope that no one notices that there's someone there and this slightly strange thing is happening.
• 7:02
  SPEAKER_01: There have to be approvals in place in order for that person to be seen in that location.
• 7:07
  SPEAKER_01: We've seen young people in school.
• 7:09
  SPEAKER_01: So again, the school is aware that this visit is happening.
• 7:13
  SPEAKER_01: And for us, the healthcare professional will sometimes need to take a centrifuge with them.
• 7:19
  SPEAKER_01: We will need to organize for a courier to bring the drug to that location.
• 7:24
  SPEAKER_01: So it's a lot of logistics and a lot of planning and just having the patient tell us when they are going out of town, when they are going to be in this alternative location.
• 7:34
  SPEAKER_01: And we work with the site to understand what that looks like.
• 7:37
  SPEAKER_01: You know, are they high up on a mountainside somewhere in some beautiful location?
• 7:41
  SPEAKER_01: We just need to plan that either our regular nurse will see the patient, or we will ask another nurse to see the patient for that that one or two visits when they're out of town.
• 7:51
  SPEAKER_01: Absolutely doable.
• 7:52
  SPEAKER_00: I am surprised that this is something that we don't do more of, but also surprised that this is an option because in many of the trials that I have witnessed, it it has been very much you come to a trial site and that is where you get your tests taken.
• 8:05
  SPEAKER_01: Absolutely.
• 8:06
  SPEAKER_01: I honestly think that society now is expecting a level of flexibility and expecting a level of almost coordination to fit in with that person's lifestyle.
• 8:19
  SPEAKER_01: And you know, that's not unreasonable.
• 8:21
  SPEAKER_01: It's not unreasonable at all.
• 8:22
  SPEAKER_01: It tends to be more of an issue when a person perhaps has a rare condition.
• 8:27
  SPEAKER_01: Their specialist is not guaranteed to be within half an hour of where they are.
• 8:32
  SPEAKER_01: It could be multiple kilometers, it could be multiple hours travel.
• 8:37
  SPEAKER_01: And you know, that in itself might just mean that clinical trials are not feasible for that individual.
• 8:42
  SPEAKER_01: So if we truly, as an industry, want to reach the people that we feel would benefit from being part of a clinical trial, we've got to design them differently and we have to think about it differently as well.
• 8:53
  SPEAKER_00: Also, every time someone says decentralized clinical trial, they usually mean something digital, something that happens over your own.
• 9:00
  SPEAKER_01: Absolutely, yeah.
• 9:01
  SPEAKER_00: But that doesn't have to be the case.
• 9:02
  SPEAKER_01: It doesn't.
• 9:03
  SPEAKER_01: No, it really doesn't.
• 9:04
  SPEAKER_01: It can be so much more than that.
• 9:06
  SPEAKER_01: It absolutely can be so much more than that.
• 9:08
  SPEAKER_01: But you're right, somehow decentralized has become synonymous with technology.
• 9:13
  SPEAKER_01: And of course that can be part of it, but it can be so much more than that too.
• 9:17
  SPEAKER_00: Yeah.
• 9:17
  SPEAKER_00: And also for some of the more complex trials where digital technology is just not the right way to go.
• 9:24
  SPEAKER_00: No, not not always.
• 9:26
  SPEAKER_00: No, not always.
• 9:27
  SPEAKER_00: When we're talking about the general evolution of the people participating in trials and also like how trials are becoming more complex and uh dealing with an ever-increasing amount of rare diseases, how are you seeing the the typical trial participants?
• 9:42
  SPEAKER_00: Are they also changing?
• 9:43
  SPEAKER_00: Are they more busy today than they were before?
• 9:46
  SPEAKER_00: How is their life fitting into the trial structure?
• 9:49
  SPEAKER_01: Yeah, and you know, I think people's lives are becoming busier, and I think there is an expectation that people do want to maximize their involvement in things that matter to them, whether it be clinical trials, whether it be participating in a society event or a movement, you know, whatever that might be.
• 10:10
  SPEAKER_01: And their condition shouldn't stop them from being able to do that.
• 10:12
  SPEAKER_01: There's an expectation that there will be a set of arrangements in place to allow people to be included.
• 10:19
  SPEAKER_01: And I don't think clinical trials are any different than that, which is why I think as an industry we have to be more responsive to where people are, what their days look like, the fact that not everyone works nine to five anymore.
• 10:33
  SPEAKER_01: People work weekends, people work night shift.
• 10:36
  SPEAKER_01: We have to stay in step with how society is developing and how it's moving.
• 10:41
  SPEAKER_01: So I can put an order in and have a coffee delivered, I can have food delivered, you can have many, many things that can be delivered.
• 10:50
  SPEAKER_01: I'm not proposing that all clinical trials will fit into that model, but that has to be considered when clinical trial protocols are put together.
• 10:59
  SPEAKER_01: What are the chances that people will come and sit in a clinic for four hours?
• 11:05
  SPEAKER_01: What does that mean?
• 11:06
  SPEAKER_01: What are we doing in terms of childcare provision?
• 11:10
  SPEAKER_01: What are we doing in terms of carer provision?
• 11:12
  SPEAKER_01: Shouldn't leave it to the individual just to try and figure that out because it's complex.
• 11:17
  SPEAKER_01: I know more about the UK, but I would imagine it's complex across Europe.
• 11:22
  SPEAKER_01: It will be complex in other geographies as well.
• 11:24
  SPEAKER_01: You know, why are we making it difficult for people to claim travel expenses?
• 11:29
  SPEAKER_01: Why is why is there so much paperwork in the system to prove that, to prove that everyone's doing everything that they need to do, when in fact it's probably acting as a barrier just as much as it's acting as a facilitator as well?
• 11:42
  SPEAKER_00: Yeah, absolutely.
• 11:43
  SPEAKER_00: How precious is the individual clinical trial participants for a clinical trial?
• 11:49
  SPEAKER_00: Because all of this sounds like a lot of accommodation for a single individual.
• 11:53
  SPEAKER_01: Absolutely.
• 11:54
  SPEAKER_01: We ask a lot of clinical trial participants.
• 11:56
  SPEAKER_01: You know, if you think about it, we're asking them to sign up to something that could be perhaps two years in length, it could be three years, there could be lifelong follow-up.
• 12:05
  SPEAKER_01: We're asking them to remain engaged in a very lengthy process when we don't know what else is necessarily going on in their lives.
• 12:13
  SPEAKER_01: The trial sites are extremely good at staying in touch with the individuals that are familiar to them.
• 12:21
  SPEAKER_01: But if this is a recruitment campaign that's been done through social media, sometimes the trial site and the caring physician of that patient might not know a lot about clinical trials.
• 12:32
  SPEAKER_01: So they're not quite as invested as perhaps your principal investigator at a trial site who's been doing research for maybe 10, 20 years.
• 12:40
  SPEAKER_01: You've got a doctor who's sitting in their clinic thinking, I don't know what any of this means, but I can't ask because my patient sitting in front of me is expecting me to support them on this journey.
• 12:52
  SPEAKER_01: So the patient is incredibly important.
• 12:55
  SPEAKER_01: And I think that sometimes we forget that.
• 12:58
  SPEAKER_01: We forget that when we we ask them to have an endoscopy every three months, but they have a condition that means that that is even more uncomfortable than it would be perhaps for you or I.
• 13:08
  SPEAKER_01: You know, we asked them to do a lot in the the name of science, and they keep coming and they keep doing it and they stay in the study, but we should not take that for granted, which is why I think as an industry we have to keep moving on, we have to keep listening to the feedback that we get from patients and from trial sites as well.
• 13:26
  SPEAKER_01: When trial sites say their patients are not going to go for this, they are not going to like this, we have to listen to the reasons why.
• 13:34
  SPEAKER_00: This is like very practical patient centricity where the trial comes to the patient instead of the patient having to come to the trial.
• 13:41
  SPEAKER_01: Yes, yeah.
• 13:42
  SPEAKER_01: Because we will find, I think, that as generations move on, we will find that there's just not a willingness to do that necessarily on the scale that we see now.
• 13:50
  SPEAKER_00: Science might not be reason enough.
• 13:52
  SPEAKER_00: Exactly.
• 13:53
  SPEAKER_00: Caroline, I'm curious, how did you end up in your current position?
• 13:57
  SPEAKER_00: How did you find your way into life sciences?
• 13:59
  SPEAKER_00: Oh goodness.
• 14:00
  SPEAKER_01: Okay, so let's go back a disturbing amount of years, more than 20 years now.
• 14:06
  SPEAKER_01: So I was working in a hospital and I felt that I'd I'd reached as far as I could go in that particular organization.
• 14:15
  SPEAKER_01: So I actually applied for a job in a different hospital as a research and development administrator.
• 14:21
  SPEAKER_01: And I'm not saying that I was I was scarred by the experience, but I remember that I joined my new team, the RD team.
• 14:29
  SPEAKER_01: I joined them at the beginning of November.
• 14:31
  SPEAKER_01: They'd been without an administrator for a period of time, so there were all of these study files on the side of the desk that needed attention.
• 14:38
  SPEAKER_01: And I remember a friend asked me somewhere around the February time, how was the new job?
• 14:43
  SPEAKER_01: Was I enjoying it?
• 14:44
  SPEAKER_01: You know, what was I learning?
• 14:45
  SPEAKER_01: And I'd said, I've made a terrible mistake.
• 14:49
  SPEAKER_01: These people talk in a language that most people do not talk about.
• 14:54
  SPEAKER_01: What is what is double blind?
• 14:56
  SPEAKER_01: What is randomized?
• 14:57
  SPEAKER_01: Controlled?
• 14:58
  SPEAKER_01: What does controlled mean in this set of circumstances?
• 15:01
  SPEAKER_01: And as I joined the RD team, they had their annual RD event where they had consultants coming to talk about their research.
• 15:10
  SPEAKER_01: And honestly, of honor, I think I probably understood about 10% of it.
• 15:14
  SPEAKER_01: And I thought, this is just insane.
• 15:16
  SPEAKER_01: What have I done?
• 15:16
  SPEAKER_01: You know, I've I've plunged myself into a world I know nothing about.
• 15:20
  SPEAKER_01: So I spoke to my director, my clinical director, and he agreed to put me on a master's programme.
• 15:26
  SPEAKER_01: And he said, you know what, Caroline?
• 15:28
  SPEAKER_01: Just do the first year.
• 15:30
  SPEAKER_01: Understand the theory, understand the methodology of research and see how you get on.
• 15:36
  SPEAKER_01: And from that point in time, apart from statistics, I'll never be at one with statistics.
• 15:42
  SPEAKER_01: I'm not going to lie to you.
• 15:44
  SPEAKER_01: But I think what I did discover about myself is that I'm probably a slightly frustrated epidemiologist because I am very interested in the why.
• 15:53
  SPEAKER_01: Why did that happen?
• 15:54
  SPEAKER_01: How did that happen?
• 15:55
  SPEAKER_01: And I think when you open your mind slightly to listening to people who ask the what if questions, what if we were to do these things?
• 16:04
  SPEAKER_01: And from them my career developed.
• 16:06
  SPEAKER_01: And I actually ended up as head of department in that particular RD department and then moved to MRN about seven years ago now.
• 16:16
  SPEAKER_01: And going from an organization, a health organization who is focused on the health of a population who did a little bit of research, moving to MRN, where everything was about research and about how we could get a drug that's only stable for a certain period of time from one end of the US to the other end of the US, taking in time zone differences and putting a nurse and the drug in the patient's home when it's minus 20 outside.
• 16:44
  SPEAKER_01: And I just loved it, absolutely loved him.
• 16:46
  SPEAKER_01: And I still love it to this day.
• 16:48
  SPEAKER_01: You know, now I get to focus in on the sites and the patient side of things.
• 16:52
  SPEAKER_01: I'm surrounded by colleagues who want to problem solve and want to think about how we can get to patients, how can we make what we do better?
• 17:00
  SPEAKER_01: And and so still after 20 years, the enthusiasm and the excitement is is still there.
• 17:06
  SPEAKER_01: Now I have to say that if you were to ask my family what it is that I do for a living, the answer that you would get is I don't really know, but it's something to do with clinical trials.
• 17:14
  SPEAKER_01: So I still think there's a lot of myth busting out there that we could do to help people understand what you and I do.
• 17:20
  SPEAKER_00: Oh, absolutely.
• 17:20
  SPEAKER_00: For a little while there, my kids thought that I worked on an airplane because I had to travel so much for work.
• 17:26
  SPEAKER_00: I can absolutely understand that, yeah.
• 17:28
  SPEAKER_00: Kaoline, a question that I always ask my guests on this show is if I gave you the transformation and trials magic wand that can change one thing in the life sciences industry, what would you wish to change?
• 17:38
  SPEAKER_01: Oh goodness, I would be a maniac for the length of time that you gave that to me, but I think it would be time.
• 17:45
  SPEAKER_01: Everything takes so long.
• 17:47
  SPEAKER_01: And I know that clinical trials can be unpredictable and everything is done to try and reduce that unpredictability.
• 17:54
  SPEAKER_01: But goodness me, everything takes so long.
• 17:57
  SPEAKER_01: Should it really still take in this day and age, should it really take anywhere between 10 and 15 years to get a new drug to market?
• 18:04
  SPEAKER_01: No, it shouldn't, is the answer.
• 18:06
  SPEAKER_01: And I think that I don't think anyone is being deliberately awkward in any of the processes that we do, but somewhere along the line we have to break that cycle.
• 18:15
  SPEAKER_00: I completely agree that there is no excuses anymore for what it takes.
• 18:21
  SPEAKER_01: There really isn't.
• 18:22
  SPEAKER_01: So many things have moved forward in such a positive way.
• 18:25
  SPEAKER_01: Personalized medicine, you know, all of the things that mean that the cancer Alzheimer's conditions are now, we understand them far better than we used to, and the clinical trials are almost behind.
• 18:35
  SPEAKER_01: You need that that is not the right way of things.
• 18:38
  SPEAKER_01: We need to speed things up.
• 18:40
  SPEAKER_00: Absolutely.
• 18:40
  SPEAKER_00: Caroline, if uh my listeners would like to reach out to you with all questions or just learn about you and your company, where can they find more information?
• 18:49
  SPEAKER_01: Please, you can reach out to me personally, so Caroline.pot at the mrn.co.uk.
• 18:57
  SPEAKER_01: You can find me on LinkedIn.
• 18:58
  SPEAKER_01: If you Google MRN Medical Research Network, please have a look at our website.
• 19:03
  SPEAKER_01: It will tell you a little bit more about our services and more than happy to chat to people with any questions that they might have.
• 19:09
  SPEAKER_00: Awesome.
• 19:09
  SPEAKER_00: Well, thank you so much for taking the time to talk to me, Caroline.
• 19:12
  SPEAKER_01: Thank you ever so much, Ivana.
• 19:13
  SPEAKER_01: Thank you.