decentralized clinical trials & remote microsampling: Jenny Royle, PhD

For this episode of the Microsamplify Podcast, Neoteryx Technical Director James Rudge, PhD, spoke with Jenny Royle, PhD, the co-director and co-founder of a company in England called Rekaryo and managing partner of a patient engagement and research company, MediPaCe. Both companies focus on linking science and technology with patients, but in different ways. Rekaryo is a service provider that helps pharmaceutical companies and clinical research organizations (CROs) implement effective research and clinical trials.

Rekaryo specializes in the regulated environments of clinical trials, healthcare, medical devices and the underlying science. They provide services to support remote or decentralized clinical trials by assisting with trial design, ethics submission, patient engagement and lay-person communications, medical science, pharmacovigilance, data analysis, regulatory report writing, among other services. MediPaCe provides strategic patient centricity consulting to pharma companies, patient engagement in things like drug development, technologies, and care pathways as well as patient research to identify and plug care gaps.

On the medical device side, Dr. Royle has worked with Mitra^® devices and VAMS^® microsampling technology from Neoteryx to offer remote blood sampling to trial participants.

Neoteryx: Hello, Dr. Royle. Welcome to the Microsamplify Podcast from Neoteryx!

Dr. Royle: Hello James, it’s a pleasure to be here!

Neoteryx: Thank you! I know that after earning your PhD in pharmacology, you spent many years working in all phases of clinical development and patient-focused research, and that a primary element of your work is delivering patient-centered solutions. Can you discuss your experiences in providing patient-centric solutions, and describe what those solutions include?

Dr. Royle: Yes, certainly. It’s probably easier to start with just a few examples. The first example, is probably best to be a system that I created called “PROACT.” It emerged because working in very early-phase trials, there is such a huge learning phase in clinical development, and it’s very difficult to answer questions, such as “What’s the burden our molecule is having?” or “What are the daily realities of actually being in this trial?” or “Which bits of the trial are easy or hard?” and “What are the benefits for the people taking the drug?”

The reason for this, is that there wasn’t a compliant way to gather their experiences. If your trial is a novel drug, what you need is to hear from the very first patients taking your drug what their experiences are. And that’s what ProAct gave. It gave a way for the participants in a trial to compliantly connect with their site, and also – for the sponsors, the Pharma companies – [an opportunity] to hear directly from the participants in their trial what the burdens are, and what their perceived benefits are. And we got gold dust! [We learned about formulation changes, and the taste of things, adverse events, and all this sort of stuff.]

The trick was to get it to work for everybody. From the patients or study participants’ perspective, they got better communication with their site. They also got within study feedback on how the study was going. For example, if you present interim results at a conference, the participants got a “Thank you, this is the difference that you are helping to make.” For certain conditions, such as end-stage cancer and other conditions that are life-limiting, you can often miss the chance to say “thank you” to study participants. If you miss the chance, that is felt by you, it’s also felt by the families, and the communities around, and is that what you want to do?

So, that was the first example. We also started doing video-supported consent to change the consent process. That was about eight years ago. It is now “normal,” but back then it was this radical new thing.

The nephron-oncology study that we did [is another example]. That involved at-home sampling to improve the renal monitoring in oncology patients. Many people have both renal disease and cancer. There aren’t that many cancer treatments approved for people with renal disease because people don’t get in the studies because you can’t monitor it properly. You can’t monitor it properly because you need to be in clinic. So, this study was an effort [to find out] if we could monitor it better with people engaged [in microsampling] from home.

In terms of experience, I’d say, overall, it is now a lot easier to do than it was. [Compared to] 10 years ago, people have switched on. They know about [remote microsampling] — it is no longer alien to them. It should be considered “normal” everywhere by now, and it isn’t. And so, certainly from what I’ve experienced, where it has worked, it has worked in a specific situation in a specific case. That tends to be because there is a person in there that can see what all the ramifications are of at-home sampling. People tend to think of it as a swap-in, swap-out — a clinic sample for a home sample — and, unfortunately, it isn’t. It has ripples and ramifications that affect the healthcare culture, the role of patients, and so much more. This is one of the reasons, I think, that [home sampling] hasn’t gone beyond these little bits yet. Everyone currently looks at their bit, and they try and prove their bit. Until somebody can use method and system to look at it across so it wins for everybody, it’s going to be a bit of a slow process.

Neoteryx: Since the onset of the Coronavirus Pandemic, the concept of decentralized or virtual clinical trials has become a reality and a necessity for many more organizations. You have experience and expertise in designing clinical trials, including those that are decentralized or off-site. Can you please tell us more about your experiences in this area and what you have learnt?

Dr. Royle: Yes, actually the pandemic is a perfect example, isn’t it? We need to understand what’s valued. We need to examine a need that they value. Was that technology there before? That assay may not have been, but was the ability to sample from home there before? Yes. Was the capability there before? Yes. But as well as the pull from the technology and the innovation, you need a great big kick for people to see the need. And, unfortunately, it was the horror of a pandemic that’s given the kick [to look at decentralized or virtual trials more seriously].

Certainly from a study design perspective, if we look at how standard study designs evolve in a pharma company, and the ones that are most adaptive and change the most are the earlier phase ones, so they will be a good example. The standard approach, to simplify it down is: you have your molecule that you have designed to hit the target very well; you’ve got all your data around your molecule; you do your translation work to mitigate risks and get your first dose schedule, so that you can go into your first human study. You write your study design concept according to all of that science. Then you ask for input from key opinion leaders and clinicians, and you hone it and refine it.

This is great, but if we’re looking at “pull” and “kick,” where people now are trying to slot in things like patient-centric sampling, or home sampling, is after that stage, they’re doing the protocol and they’re saying, pragmatically, “Should I swap this sample for this one?” “Could they do this in the home or could they come in?” And what that means is that you are not getting any main “pull,” you’re not really getting any main “kick.” The decisions are effectively a cost-based decision, and a decision based on, “Well, I’ve heard that [home sampling] might help with recruitment. Or “It will look good for this study.” These are not major drivers. You need numbers. You need facts. And a cost for swapping in [samples] here and here, is unlikely to be enough of a driver to make that change happen.

If you go back a step, to study design concept or back to your protocol or target profile — right at the start — and instead of looking just at the science of it, you map out the landscape. You will get an entirely different approach to how you are doing it. And that’s where the value comes in.

Neoteryx: So, I’d like to learn a little bit more now about why you decided to co-found your company, Rekaryo as well as heading up the company MediPaCe. I believe Rekaryo serves many different types of companies and customers looking for help with studies and trials, and MediPaCe helps Pharma engage with patients. Can you describe the different types of customers you serve and explain how you adapt your expertise to their needs?

Dr. Royle: Rekaryo actually emerged because at that time I was working in academia as one of the leaders of a research group, and I kept getting asked questions from the rare disease world. This was generally when people had all the great ideas and they had willing people, but they were stuck. [Maybe they] had a need they didn’t know how to address or they had a research question [for which] they couldn’t design the trial; or they had a great study design, but they didn’t know how to analyze it; or they just needed the medical writing support because they couldn’t explain hardcore genomics to the general public. There was usually something.

One of the things that my background gave was this really broad spread of experiences, and it meant that for these people I could simplify the question down by looking at it multiple different ways. I could just say, “You need to do this,” and then do it for them. That’s why I ended up setting up Rekaryo because nobody else seemed to be doing that. They seemed to be serving people by reapplying the same service model to different situations, whereas Rekaryo does it differently. It listens to the problems and questions at hand, and then pulls from that broad experience to [ask], “Around your question, what’s the simplest, easiest, best way to address that?” And then [we] make it happen. Because of those bespoke solutions, and because we are small, it means we can be cost effective [in] doing that, and taking people from – whether it is the labs to the clinic, or whether it is a pharmaco-vigilance issue that they are struggling for engagement with, whether it’s a trial design they need writing, or whether it is just a simple blog they want writing [to simplify] something that is quite scientific— whatever it is, we take that specific thing and look around it, and create a specific solution that just works. For Rekaryo we tend to have consortia, charities/non-profit, and startup Pharma, as well as established Pharma that we serve.

MediPaCe came later when I linked up with some old friends. [This was because] Rekaryo, when it started, had at is core wanting to make people feel better and have a better quality of life. In the medicine world, that’s patients and families. For doing the patient engagement work efficiently and well, you actually need quite a broad skill set. You need people that can do the focus groups, the ad boards, the facilitation, the engagement, and the co-creation. You also need people that can do patient preference studies, research to fill care gaps, and people who can go into pharma and say, “If you want to engage well, this is how systematically and strategically you need to build it into your development program so that it blends with the other things that you already do.” That’s a lot for a small company like Rekaryo to do, and also, it’s a very different client base. Even though logically they [may] overlap, in terms of delivery of a service, they don’t tend to yet. So, MediPace is actually a group of us that have a blend of skills that can do all of that, no matter what the question that comes in. And Rekaryo focuses on more of the bespoke problem-solving rather than the big pieces of patient research.

And I have to confess, in my mind, the future of standard monitoring is probably people being able to get the result there and then in their own homes so they can action it quickly, get help when they need it, or monitor it and know they’re alright, and be able to spot trends. But, we always have to innovate, and there are always better biomarkers, and there is always a better way. That is not going to be done in point-of-care devices. That’s going to be done with things like the Mitra^® [devices with VAMS^®] tips with things where you develop the assays in the lab, and you prove the benefit and the worth. And then if that’s okay, perfect. If it needs to go faster then…well, if the whole field is being pushed on further…[great], but point-of-care is unlikely to push on the biological science side of it as fast. Because that’s just not the way that you would design the assays.

Neoteryx: Yeah, and it’s really fascinating because it’s using things like Artificial Intelligence (AI) to be able to do that pattern recognition and, actually, a lot of that has already been invented for search engine searches and bringing in big data to understand patterns in noise such that…so that you can link disparate pieces of technology and bring the data together to make something that is significant. It’s really fascinating, and a really exciting kind of future, isn’t it? So, talking about the future…

How do you think remote microsampling and remote specimen collection devices facilitate the design and evolution of virtual trials trends? And do you think most clinical trials will shift to off-site or a decentralized model, or will there always be room for a hybrid that offers people an onsite component as well as offsite? Do you think everything will eventually move to the home?

Dr. Royle: Well, this is me you’re talking to! I think it depends on the question, of course. There was a paper out not that long ago where they compared the telehealth and at-home (in medicine/healthcare) vs. in-clinic. And they had different profiles of benefits, and different profiles of preference: telehealth and at-home care all linked together gives far more individualized care, a far more immediate response, and immediate care. It usually works out cheaper or preferrable, more so for the participant than the healthcare professional, but a little bit of both. Especially when you think about how overworked they are — I think it was something like 40% saving here vs. 7% over here. But, face-to-face in clinic was so much better for people that had low self-care ability or people that had really life-changing discussions that needed to be had, or big strategic care decisions: Do they go in the trial or not? Or, for something like COPD or cancer it’s a really big decision: Do they drop standard of care [in-clinic care] and swap across to this [telehealth]? The reassurance of having that conversation face-to-face, and the body language and emotional support in that, [can be] incredibly valuable.

I think that it depends on people’s ability to self-care. As we already know, in clinical trials, that screening already happens. People are only recruited into trials on a very rough assessment from the clinicians to go, “Well, are they likely to be able to comply with the protocol?” If the answer to that is dodgy or “No” then they are screened out quietly anyway. So from a trial perspective, I don’t think that’s the main thing. I think it comes down to the amount of face-to-face support people will need to get back from the trial the care they feel they need to be able to go on. So, if it is something like a rare condition where, yes people need the care, but the impact of traveling on them (if it’s 300 miles away) versus the benefit back, doesn’t add up. You’re going to go totally remote.

If it’s something that is a lower value, you just need something that is actionable there and then — you’re feeding in data and you’re getting your drug tweaked, you already know about it — you’re probably going to go virtual/remote as well. [This is] because it’s going to be individualized, it’s going to be fast-acting, they’re going to be getting what they need.

If it’s something where people need to come in, or they need intensive scans, or they need something that’s far more invasive, they may need to discuss through the finer points, they will need that sitting time. And this is very hard to do, even with telehealth, the sitting quiet time where the clinician walks out and then comes back in a bit later, or they just sit silently while someone is puzzling it over. That’s far easier to do face-to-face than when you’ve got someone on the other end of the screen kind of waiting. A screen conversation is far more ongoing two-way. To end the call, you then have to phone them back. You can’t just pop out and pop back in. For that, I can see, it needs to be in [clinic].

I think there’s a place for everything. I also there’s a place for satellite sites, and those satellite sites don’t necessarily have to be vans that go around or the GPs, or other local hospitals. They could be some of the shops that are now free that could be set up. There are a lot of cultures where people do not want someone from healthcare coming into their house. [Some] people do not want the testing in their own house. And there is a myth currently, that decentralized trials increase the diversity in trials. I’m sure it can, but I haven’t seen any concrete data where it’s done it on its own…again, it needs that bigger picture…it’s not about catering to every sing person, it’s [more] about knowing where the choice points are that will make the biggest difference. And, in that case, in this choice point, is it worthwhile having it so that they have something in the center of this town or that town…and people travel shorter distances, if they don’t want it in their home, or at home rather than in clinic, as an option.

I think again it comes back to the research option. I think there is room for all. What I would love to see is that home microsampling is seen as an as valid starting point as the current standard of care with in-clinic sampling. So, they start equal, and the choice is made [based] on the need and the question. Not, as currently happens, with just standard of care, and you have to really argue with me to change it to this one. That’s not helpful to anyone. But we’ll get there!

Neoteryx: That’s quite interesting, isn’t it. There was actually a paper, I think it was by Astra Zeneca, that got published last year, which is actually entitled, “Giving Patients a Choice.” It was discussing that very same thing. Giving people options, and then allowing the patients to be able to choose what it is that they want to do. And that was a really interesting point that you just raised about making it easy for people to access that test or service or whatever it is by using empty shops. What’s really interesting is that, of course, with the pandemic, people have now gotten used to that kind of thing — going to a shop or a car park in the middle of nowhere to go and get a swab. There’s a really interesting study that happened in the US where people were asked to give blood samples for serology studies, and they went to the local supermarkets [malls] where there was a station where that sample could be collected.

Dr. Royle: Even more simple. If you want an at-home Coronavirus Test Kit, you pop over to the local pharmacy and get one. You’re getting human interaction, it’s really handy, all you’d need to do is buddy up with a pharmacy chain and you could have all of that. And, if you need a little bit more face-to-face description, well why can’t the pharmacist do it? They don’t have to go into clinic for it. But again, it’s about designing around what people need rather than what is standard of care.

Neoteryx: Your expertise in all these areas has been absolutely fascinating, and it’s always lovely to talk to you Dr. Royle. Obviously, you’ve got your two companies. Where can people get in touch with you to find out more about your companies, Rekaryo and MediPaCe?

Dr. Royle: People can visit our websites at: Rekaryo.com or Medipace.com.

Neoteryx: Thanks again for discussing your work and sharing your precious insights into clinical trials and research! We wish you and your colleagues at Rekaryo and MediPaCe much success with your clinical trial support services!

And, also thanks to our audience for listening to this episode of the Microsamplify Podcast, a partner to The Microsampling Blog from Neoteryx. Thank you!

Image credit: Dr. Jenny Royle, Rekaryo, MediPaCe