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Driving efficiencies through virtual trial solutions in Asia Pacific

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22 October 2021
WEBINAR

SCRIPT

Arsalan Arif: Hi everyone. I’m Arsalan Arif with Endpoints, and your MC for today’s webinar, Driving Efficiencies Through Virtual Trials in Asia Pacific. We are sponsored by Novotech, a leading Asia Pacific biotech focused CRO, and thanks to Novotech for bringing another great webinar to our audience. In July this year, Novotech and ObvioHealth, a US-based virtual research organisation, formed a partnership, and with Asia Pacific being such a fast-moving market with an appetite for virtual trials, we’re excited to see what our speakers from these companies have to share about their collaboration and clinical trial growth in Asia Pacific region. We have four great panellists today for today’s webinar, representing both companies, and let me introduce them real quick.

First up, Matty Culbreth-Notaro, Chief Operating Officer at ObvioHealth. Next up, Daniela Caiazza, Director Clinical Operations, Novotech. Kirsten Kinsey, Team Lead and Client Operations at Novotech. Erin Haumann, the Director of Asia Pacific at ObvioHealth. And the panel discussion will cover what is driving that celebration of clinical trials in Asia Pacific, debunking decentralised clinical trial myths and understanding the reality, and key considerations to maximise the opportunity for DCTs and hybrid Asia Pacific trials.

Now, I’m going to turn over to Daniela Caiazza. Daniela?

Daniela Caiazza: Great. Thanks, so much, Arsalan, for that warm introduction. Really pleased to be here today speaking with Kirsten, and our ObvioHealth partners. Just a brief introduction, to start off, to Novotech. We are a leading Asia Pacific CRO. We’ve been established since 1997, so we’ve been in operations close to 25 years. We offer clinical trial management capabilities, so that ranges from all of our regulatory consulting and expertise to support with those initial IND packages, through all aspects of the clinical trial operation services. We have phase 1 clinics across the region, in China and Taiwan, we have lab capabilities in some areas of our region and we can support all the way up to those final NDA submission packs for submission to the regulatory authorities at the end of the study.

Our current staff numbers, we have over 2,000 staff that reside across 11 geographies across Asia Pacific and the United States and our largest teams currently in China, Australia and South Korea. We also have client facing teams that reside on both the east and west coast in the US. In terms of our customers, we are a biotech specialist, so we really work with innovative biotech companies and we can support them through their early phase clinical trials, all the way through phase 2, phase 3 of course, and up to post-marketing studies if needed. In terms of therapeutic areas and indications, we really do mirror the current clinical trial landscape, so we do a large proportion of our studies, early phase, early phase healthy patient volunteer studies, oncology studies and many other therapeutic areas and we have a lot of work in infectious diseases.

I guess the final note that I’d like to highlight and that is we have really strong, local leadership and operations teams in all of the regions where we have a presence, and that helps us with establishing relationships with medical institutions, principal investigators and, of course, the regulatory bodies which is really critical to executing clinical trials in this region.

With that, thanks for the opportunity to introduce Novotech. I’ll hand over to Matty.

Matty Culbreth-Notaro: Really appreciate it, Daniela. Years ago, the FDA called for technology to be incorporated into our industry, really in the hopes of bringing forth further efficiency into our clinical trials. In 2017, ObvioHealth answered that call and developed one of the first patient-centred apps to support the need for a real-time data collection, to really do things like increase participant engagement, compliance, retention, completion; all of the things that significantly improve the overall efficiency of our projects. And, of course, these are enormous benefits and impact to our industry but, most importantly, to our participants, and it starts by having the right tech solution.

Our platform is not a web-based system. It’s actually fully integrated in secure cloud-based platform, where the participants can use their own smartphones to enter their data and complete the study-related activities. Of course, we do support the need for study design and implementations, but our support goes way beyond the digital. ObvioHealth offers an end-to-end solution. We have the ability to support the clinical trial from inception all the way to closure with our comprehensive ecosystem inclusive of medical writing, data management, recruitment services, bio stats, and other services like that.

But it’s really our ability to provide that great participant support to our patients with our remote psych team, who we call “The Coach Team” which makes a great impact on each of our projects. Our highly experienced team of scientists and researchers and product team and the participant support team, to name just a few, help to marry the tech and service, to provide that comprehensive support of the clinical trial and, more importantly, to the research participants.

Arsalan Arif: So, questions for the panel. What is driving the acceleration of clinical trials in Asia Pacific?

Daniela Caiazza: Thanks, Arsalan. I think there are four key reasons why Asia Pacific is the fastest growing clinical trial region globally. First one, patient availability. There’s 60% of the world’s population residing in Asia, and not only that, they reside in high density urban centres with really close proximity to medical facilities. Another key factor is a lot of these patients are treatment naïve, and so in terms of our customers and our biotech sponsors, to be able to tap into that potential patient pool is really attractive for them when they’re considering expanding their clinical trial across the region.

Medical facilities and principal investigators. High quality infrastructure, high quality medical institutions, clinical trial sites. So it is a really attractive reason to expand clinical trials in this space. Data quality, really high; worldwide acceptance of this data quality as well by the key regulatory bodies in the FDA and EMA. And finally, cost competitiveness. You know, compared to running clinical trials in the US and Western Europe, Asia, is really a cost competitive market.

And I’ll now hand over to Kirsten, who’s going to give us a little bit more information and a bit more flavour to those.

Kirsten Kinsey: Asia Pacific has become a key destination for trials due to three key reasons. Firstly, the region has a proven track record when it comes to recruitment. As Daniela mentioned, with over half the world’s population living in Asia, there is a large pool of patients to draw from. You can see here how Asia Pacific compares to rest of world in terms of a monthly per patient, per site recruitment rate for oncology studies over the last three years or so. The region is approximately 30% faster when compared to all locations combined for complex studies, making it an attractive destination for trial conduct.

That, combined with the lower trial density as compared to the US means access to world-class trial sites that will have the time, resources, and access to the required patients. Australia and New Zealand have historically been popular choices, but we are very encouraged by the interest being shown in South-East Asian regions such as Hong Kong, Malaysia and Thailand – and I’ll touch on China as a growing market in a minute.

As the region develops, more and more Asian investigators are also making their mark on the global stage with the number of key opinion leaders in Asia Pacific publishing peer review [dates] are growing by 10% since 2005. And something else to mention is that most Asia Pacific regions have well-established regulatory pathways. In most cases, submissions can occur in parallel, which makes for an efficient start-up process.

I want to touch on a specific example of comparing to China to the US when it comes to some key performance indicators. China consistently has a higher recruitment rate, and you can clearly see how the region outperforms the US in oncology studies, as well as a few other popular indications, such as infectious diseases. When we compare China to the US, in this example for a non-small-cell lung cancer study, China has much higher patient access when considering the number of newly diagnosed patients. Recruitment rates far exceed what the US delivered, and for more than half the cost, and this is just one example why Asia Pacific is the preferred destination for clinical trials.

Thanks, Arsalan.

Arsalan Arif: Thank you. Next slide, please. Panel question number two. Debunking decentralised clinical trial myths. So for that, let’s turn it over to Erin, please.

Erin Haumann: So, there are quite a few myths around decentralised trials that need to be debunked. The first one really is that the technology that’s being used is just too complex. It’s more of a concern when speaking to our clients than it is for actual participants who are really able to manage it and happy to engage with it. The app is very simple to use, and our data shows that participants of all ages, after viewing on-demand training videos, are really comfortable with it, particularly eDiaries and ePRO and data entry screens. When they do forget a task, our virtual site team that Matty mentioned earlier reminds them. So, we have really high levels of compliance, typically around 88% on average.

Matty, I guess you can talk to the next one.

Matty Culbreth-Notaro: Sure, yeah. I mean, Erin’s so right but there’s so many myths, and here’s another one here, that the decentralised clinical trial is less accurate. And the reality is that because decentralised trials are able to collect data in real-time, we can avoid the parking lot syndrome and all its associated things, like recall bias which actually gives us data that is more accurate. With the DCT model the study-related activities and questionnaires, they’re actually completed in real-time and the data is entered in real-time, therefore creating way more accuracy in the data than with a traditional clinical trial. The remote patient monitoring from home is just another way where we can collect more and better data than having to wait for the clinic visits.

Erin Haumann: Yeah, and that leads right through to the next one, which is that the platform is not requiring human intervention. The platform allows for everything in a clinical trial to be automated, yet having remote study teams, in fact, requires extra care for patients to ensure that they have ongoing management and feel that human connection that we get in a normal clinical study. Participants should be able to reach out to a support team whenever it’s required via a chat, or phone, email, or video, whatever method is convenient to that participant. In our experience, when this is done properly, participants feel like they’re receiving even more oversight than a traditional study.

Matty Culbreth-Notaro: That’s very true. This is why the last myth, which is decentralised clinical trials aren’t safe for participants, is kind of off the mark. When properly designed, the decentralised clinical trials are extremely safe. Of course there’s situations where it’s very important for the participants to go into a site to be monitored but, you know, in many cases remote patient monitoring provides increased patient safety because the decentralised clinical trials, it enables that real-time monitoring. We can identify and address adverse events much quicker.

Erin Haumann: We thought it might be helpful to share some of the hard and fast facts that we generated over the past number of years that we’ve been in operation down in this end of the world. The first example is from the recently completed digital therapeutic study. Our sponsor had assumed recruitment for this study would take about 24 weeks. By decentralising and recruiting via targeted digital media, we were able to recruit that study in six weeks, and approximately 20% under the expected budget, which is huge. Another interesting data point from that study was the compliance rate. People often assume older participants would struggle using technology in an app. In fact, we found in this study the women over 65 had slightly higher ePRO compliance rates than their younger cohorts, with an 89% compliance rate.

Our second example is a decentralised infant SGID study that was conducted in Thailand. We used completely digital methods and were able to pre-screen 14,000 patients for this study over a period of only seven weeks.

Matty Culbreth-Notaro: We also wanted to share an example of how our user-friendly app can help boost compliance in a DCT world. This study here is from a recent DCT trial study that was targeting menopausal women where we created an easy way for women to log their hot flashes each time, they had one, and record how long it lasted with just really a click of a button. So, it allowed for the study team to accurately track the events, and the ability to log this event with just a click of a button and therefore get more accurate capture and frequently of events is definitely a step forward in the entire industry. You know, it’s helping not only to bring real-world evidence more concretely into clinical trials, but also helps to increase compliance and the overall compliance for the ePRO in this case was about 89%.

The last example here is a COVID-19 study. It’s around an ongoing hybrid trial evaluating a new drug to treat COVID-19 symptoms that was designed to monitor patients very closely using the devices to track symptoms and collect a variety of measurements from the comfort of their own homes. The project calls for integration of five different devices to track everything like blood pressure and cardiac signals, heart rate and oxygen saturation rates, just to name a few. The participants were pre-screened at the clinic, they were trained, sent home with the devices with on-demand training videos that were available via the app if they needed it.

But in addition to that, the nurses visiting the patients in-home, you know, kind of at the middle and at the end of the study also provided that extra, you know, data we were able to collect for the study. The rest of the trial was actually done virtually using the ePRO and remote patient monitoring which allows the patient to participate in this important study while recovering at home with limited exposure to the healthcare workers. So, as you can see in each of these cases, it’s all very different. You know, what they have in common, though, is the ability to enable patients to participate from the comfort of their home, to collect accurate data remotely while providing support from the virtual site team. All of the data unified into a single EDC, with real-time dashboard accessible to the sponsor to track the progress, makes the project very efficient.

Arsalan Arif: Thank you. All right, question for the panel. So, Daniela, can you walk us through some key considerations to maximise the opportunity for decentralised trials in Asia Pacific? Next slide.

Daniela Caiazza: Thank you. So, I’ll start off with the first couple here, and then I think I’ll hand over to Erin for the last three. So there are obviously key considerations when running any trial, and perhaps even more so at the moment with the DCT because it is, you know, early on in the evolution of these types of trials. So, adaption to different regulatory frameworks; really important when running any trial, especially a DCT. It’s important to address the regulatory questions early, to understand, depending on virtual capability is going to be incorporated into the clinical trial, which region you’re going to plan to implement that virtual capability, really having that understanding of the regulatory requirements in each region, and they can differ, and some regions are a lot more open than others to some virtual aspects. So, really important to have that established upfront.

Cross-cultural sensitivities. These do need to be considered when running trials in Asia. Probably the best way to speak about that is perhaps to give an example. Across the region, patients are very reliant on the guidance and recommendations from their primary care physician. So, that is something that would need to be considered in a DCT where they may have oversight from a clinician that they’re not as familiar with. Of course, there’s always ways to get around that, introducing telehealth, having the primary care physician involved even if they’re not a primary investigator, so it’s those sort of sensitivities and understanding of how the region works. Having that expertise, having that partner that can share that knowledge with any sponsor at the beginning is always really valuable.

Erin Haumann: Absolutely. From the technology side, you’d be wanting to consider your data integration. The optimal decentralised trial should have a unified data model. All patient data is entered into a single repository, making the process seamless for the patient, as well as the backend team who are looking at the data. This results in speedy data collection, speedy cleaning, and an overall faster trial. Your device choice is also extremely important. Any remote devices have to be chosen with care to ensure that they are validated for the desired outcomes within the desired country, and that they’re user-friendly for participants so that there’s no difficulty with getting the data that we need. They also need to be fully integrated, as mentioned before.

And, finally, your data security. It’s essential that the strictest data security measures are maintained to ensure patient privacy. All data must be encrypted, it must be password protected, and controlled according to the highest clinical trial compliance standards. So, next slide, thanks, Arsalan.

Kirsten Kinsey: Thanks Erin and Daniela. So taking into account some of the key considerations you’ve just heard, you may ask yourself, how will we know if our planned study is suitable for a decentralised model? And it’s not a black and white answer. The relevance of a decentralised approach will need to be determined for each study. The benefits of the Novotech ObvioHealth partnership enables us to collaborate closely to determine when a full centralised model is best, or when a full site-based model is warranted. In many cases, a hybrid trial is the solution, which incorporates certain digital modules of a decentralised trial, together with other site-based components.

Ultimately, decentralised trials give patients more options that allow them to decide where they’re most comfortable for their study visits, be it onsite, via telehealth, or their own home. The flexibility provides more choice for the patient, and is a sign of the move to the greatest patient centricity which is made possible by having decentralised modules incorporated into trial designs. Next slide, thanks.

Erin Haumann: So, to sum it all up, there really are so many benefits of incorporating virtual components into trials that are running in APAC. They are very fast, they can help to speed recruitment, pre-screening and onboarding into a study. The reduced patient (0:21:53) leads to a lower dropout rate and can also help maintain study timelines through intense retention. They’re very flexible. The modular architecture allows true flexibility with allows for very efficient changes to study design, and allows us to pivot if required. They’re more accurate, so real-time data capture and remote patient monitoring generates better real-world data. We have very easy ePRO and virtual site teams that increase compliance for better outcomes measurement. You have securer IT and data collection, which means that, at every level, data is protected, it’s the highest priority, and we ensure privacy and security. And that it’s safe; we want to make real-time monitoring overseen by virtual site teams, we want to ensure rapid identification of adverse events, and enhanced patient safety.

This really is a new approach for our region. We’ve just launched the first full decentralised trial in Australia, and we look forward to many other opportunities to bring its benefits to other sponsors within the region. Thanks, Arsalan.

Arsalan Arif: Well, let’s move to our Q&A session now, we’ve got some time over here. Matty, I’m going to pose this first question for you, and this is a broad question, but what are the benefits of virtual clinical trials compared to the traditional ones, Matty?

Matty Culbreth-Notaro: So, there are many benefits to the traditional clinical trial. We know them, we’re familiar with that, but there are also many benefits of the decentralised clinical trial that have significant impact for both the sponsor and for the participant. For the participants, the decentralised clinical trial, it reduces the overall burden to participate and just makes it more convenient for the participants. People tend to have their smartphones on hand everywhere they go, so that means they have the app available to them, too, which makes it just more convenient to report their data from the comfort of their own homes. Like, if a medical assessment or a lab is needed, or a telehealth or a home visit, all those things can be organised through the decentralised trial.

Labs or imaging can be conducted locally, rather than have to travel to the sites every single time, or the home healthcare agency can come to them. With the digital recruitment, we’re no longer geographically bound, which makes trials far more accessible to a broader and more diverse population. For the sponsors, well, easier recruitment lends to more cost and more time efficient trials, and because the trials are just easier and more convenient for the participants, the compliance and the retention rates for the DCT trials are typically much, much higher than for a site-based study. I mean, the ability for participants to report remotely, and in real-time, it just delivers more accurate and more robust data and, you know, the sponsors, they can visualise all this data more readily and make strategy decisions more rapidly based on the data that they’re getting in real-time.

Arsalan Arif: All right. Can you help us differentiate between a 100% remote and virtual centralised trial, and a hybrid trial?

Matty Culbreth-Notaro: Sure. So the traditional clinical trial is what we expect, you know, going to a brick and mortar site. A fully decentralised trial, however, it enables the participants to go to have a visit, which is typically at a brick and mortar site, but the study participants can do it, you know, an entire clinical trial, again, from the comfort of their own home. They can give electronic informed consent, they have their study product shipped to them directly, they can report all their data via their app, they can use the devices to capture the vital signs remotely, like EKGs, you know, oxygen saturation rates. They need to submit their samples, that’s okay, they can be collected, you know, conveniently at a local laboratory or, like I said, via the home healthcare provider and, in some cases, participants can collect their own samples, actually, via the DIY kits.

The hybrid DCTs include elements of both a traditional clinical trial with visits to a central investigator site, and a DCT where the data is just collected remotely.

Arsalan Arif: Okay. Wonderful. Daniela, there’s a question for you. So, how are site responsibilities handled in a virtual clinical trial? Daniela.

Daniela Caiazza: Thanks. Well, Matty’s touched on a lot of this as well, and I know that Obvio’s really passionate about their Coach Team. So look, in terms of a DCT rather than having all of the site staff onsite, there really is that remote model. But they function in very similar ways, in terms of walking the patient through the eConsent, through all the sort of study procedures, and also reaching out as much as needed, as Matty said. And I think it really works in that if there are some aspects that are onsite, then the patient gets both the remote Coach Team and the onsite team, and really it has shown in a lot of the examples, that Matty and Erin have spoken about today, that real patient engagement and enhancement and retention for the patients as well, to have that constant contact.

Arsalan Arif: Okay. All right. Erin, let’s turn to you. So talk to us about what determines whether a study could be a decentralised one, and are there specific phases which are better suited to this?

Erin Haumann: Yeah. So the ability to go virtual really depends on the study objectives. The corresponding requirements of patients and, I guess, the outcomes that you’re expecting to get from that particular study. We work really closely with sponsors to design the best solutions for their means. Most studies can implement at least a component of the virtual model, which helps reduce patient burden and facilitates remote management and monitoring. Studies that require face to face medical oversight will not be a fully virtual study, but can still employ decentralised elements to minimise onsite activity and to gain some of the benefits we’ve discussed.

Arsalan Arif: Great. Erin, a question about your operations there. So, where does ObvioHealth operate and run trials outside of the US? So, essentially, what is your international coverage?

Erin Haumann: So, we have a global coverage. Outside of the US we have a team across Europe, but we also have a relatively large team out here based in Asia Pacific. So our main teams are in Singapore out of a hub we have there running the more Asian cultures, and we have run studies in almost every country that operates out of Asia Pacific at the moment. And then we have our Australian based team down here who cover Australia, New Zealand and run that more Oceanic geography.

Arsalan Arif: Can you tell us more about the quality of the data; how does the quality of the data that your collecting here compare to what’s collected on a site?

Erin Haumann: So, as Daniela mentioned earlier, sponsors are recognising that virtual trials, when planned and conducted properly, can deliver better data than traditional site-based trials. Rather than having an over verdant participant who reluctantly completes the study requirements at the last minute before a site visit, you have someone who remains engaged and is more likely to stick to the protocol. Activities like vitals, measurements that have been historically performed onsite can often be adapted to fit a decentralised design with device integration for a continuous monitoring effect. We have a next generation ePRO where all data flows into a single study dashboard for very seamless, real-time data review. ObvioHealth’s capabilities also enable detection of novel outcomes and biomarkers using unique instrumentation that leverage remote patient monitoring. We can use images, audio, and video in combination with artificial intelligence and machine learning techniques.

Arsalan Arif: Now, Matty, I got a follow-up question for you. You’ve talked about some patient engagement and compliance, so how does ObvioHealth’s approach to trials improve patient engagement and compliance? Anything else you’d like to add on that point?

Matty Culbreth-Notaro: Well, yes, because I know that’s a really important point for the effectiveness of a trial altogether, right? To increase the patient engagement, compliance, retention, completion. And so we do that in many ways. You know, again, one of our ways is through the Coach Team, right, the Coach Team will help with that, but another way is really that we build in alerts, notifications, and reminds into our system. So, the app will then release a notification or a reminder to the participant saying, “Hey, don’t forget to fill out your questionnaire,” “Hey, don’t forget to take your product.” If at any time we see that the participant is kind of not being compliant, or not doing what they’re supposed to do, of course the system will alert us and then our Coach Team can then reach out to the participant and just send a gentle reminder and usually get them right back on track. So, that helps with the overall engagement, completion, which is really what makes the project so effective.

Arsalan Arif: Okay. All right. Kirsten, what can you tell us about the methods that are used to recruit participants?

Kirsten Kinsey: There are various ways of managing recruitments in your clinical trial. Most of the opportunities, the recruitment opportunities are done digitally, so there is a lot of work with social media, such as Facebook campaigns, and the ObvioHealth team have a very strong recruitment team to support recruitment into the particular trial. And from that perspective, using digital recruitment, you’re also (0:31:58) eliminating geographic boundaries, so you’re allowing people access from wherever they are located to be able to participate in the trial. In that regard, we see recruitment to be pretty successful when it comes to decentralised trials.

Arsalan Arif: Okay. And so what can you tell us about your approach to increasing diversity in your trials, Kirsten?

Kirsten Kinsey: So we eliminate some geographic boundaries. We’re giving access to people who wouldn’t otherwise be able to join a clinical trial, so someone who lives far away from a trial site, or who may not be registered on a registry, for example, on a rare disease, so they may be suffering silently of a particular disease. So, given that chronic problem with underrepresentation of minorities and specific demographics in trials, virtual recruitment and the access to trials via a decentralised platform, that’s a very important step to breaking down those barriers.

Arsalan Arif: Okay. And so what can you tell us about timelines? So, are you recruiting patients faster compared to traditional recruiting methods?

Kirsten Kinsey: So what we’ve found is that the average virtual trial recruitment length is maybe about less than three months, when the average traditional trial recruitment is about 12 months. In a trial for a digital therapeutic study that was run recently, the sponsor assumed about a 24-week timeline, and in actual fact the study was fully recruited in six weeks. Again, recruitment is dependent on the required patient population, but I think it’s relatively safe to say that digital recruitment strategies play a big role in shortening recruitment timelines.

Arsalan Arif: Okay. Matty, what can you tell us about medical devices or sensors or the wearables of your platform? What does it support?

Matty Culbreth-Notaro: So it supports really any Bluetooth enabled device, and we’ve actually just recently – I think I spoke about the COVID study where we integrated five different devices into our platform. So, we’ll take the device and work with our design team and our developers to then work with the codes to integrate that device into our platform, where what happens is, that we’re able to collect information or data either continuously or in point in time collection. So, you know, instead of having the participant actually manually enter the data, like manually their respiratory rate, or their pulse, or anything like that, we don’t have to do that. They just wear the device or the wearable and it automatically collects that information and uploads it into our app, so that we have the ability to monitor that patient remotely, and if we have any alerts or any kind of results or are out of range, we’re able to then talk to the participant and just kind of check up on them, make sure they’re okay.

So we do have that ability, and we do it often and, like I said, just recently integrated five different devices. And sometimes that can be too much, you know? I mean, we’ve learned that maybe five devices is a lot and we’ve had to cut that down to make sure that it’s something that the participants can properly digest in bite-sized pieces but, you know, with the training videos and the Coach Team supporting them, it actually really works out pretty well.

Arsalan Arif: Very cool. Kirsten, what is the role of a site in a virtual trial?

Kirsten Kinsey: So, the amount of physical sites in a decentralised trial varies depending on the design. In a fully decentralised trial, data capture most often doesn’t require a visit to a clinic at all, but rather completed at the participant’s home via the digital platform. Responses are automatically uploaded to the platform and reviewed in real-time by the decentralised team. In other cases of a hybrid trial, where a physical doctor or lab visit is required during the trial, the platform facilitates scheduling with the medical professionals as well as with labs or imaging networks that Matty’s already mentioned previously.

We also don’t want to take away the value of the involvement of investigators who work as principal investigators. As Daniela mentioned previously, often patients have a trusted relationship with their primary care physician, so these investigators, we think, can be decentralised trial advocates, and with their buy-in can also support patients navigate what may be an unfamiliar concept to them.

Arsalan Arif: Okay. Can you quickly tell us how the study coordinators communicate with the participants?

Matty Culbreth-Notaro: Sure. You know, like I mentioned earlier, the Coach Team is kind of the heartbeat of our company, and to explain them a little bit better, the Coach Team is a remote site team that operates, you know, much like a typical site team would. It’s comprised of investigators and coordinators that will support the participants, so it’s just like you would find at a regular site. The ObvioHealth platform and app, it offers multiple options for communication within the participants and the study coordinators, so basically, they can either choose to email, or to of course chat, call them on the phone, or to do televisits, but also it has a chat functionality built into the app where the participant can just chat with the study coordinators or the principal investigator through the app, like an instant messenger type of thing. So, what happens is, once they chat and they converse, the app will then do a timestamp and a date stamp of that conversation, and then that becomes part of the data set for the project. So, it’s a really nice way to capture all the information, capture the conversation, and ensuring that they get the information that they need, when they need it.

Arsalan Arif: All right. Great. Let’s just wrap up. We’ve got one last question, and we’ll just do a roundtable real quick, if everyone could provide one or two key points about decentralised trials and the benefits, what would it be? I’m going to start with you, Erin.

Erin Haumann: I would definitely say that we’re bringing the trial to the patient, that we’re doing it in their own environment. Because it’s real-time data, because it’s where they’re comfortable, the compliance rates are huge. We’re really meeting that need for patient centricity in our study design, and we’re finding that we’re getting a much higher level of engagement with the study.

Arsalan Arif: All right, thank you. And Kirsten, how about you? So, one or two key points in summary.

Kirsten Kinsey: For me, the key points of a decentralised trial is the flexibility of it. We know that we’ve got options to be able to follow a traditional model as well as a hybrid model, or even a fully decentralised model. The flexibility is there to incorporate certain aspects, to be able to suit an individual trial on its own, which makes access to the patients easier, it makes the capacity of sites to take on more trials a little bit easier because some of the patient load, or the burden, is taken offsite. So for me, flexibility is the key.

Arsalan Arif: All right. Thank you, Kirsten. Okay, Daniela.

Daniela Caiazza: Well, I think Erin and Kirsten touched off all the really key points, but look, for me, absolutely it’s the opportunity for our customers and for our biotech sponsors to really have that flexible model, that flexible approach to how they can run their clinical trials, and it really is a truly patient-centric model. I mean, I think we’ve spoken a lot about this over the last couple of years, COVID has really, as I’ve mentioned before, helped us drive a lot of these virtual capabilities. It’s a seismic shift to how we manage our trials. Now it’s the trial to the patient rather than the patient to the trial, and I think that opens up clinical trials for a much broader, more diverse patient population. They get access to, you know, potential new therapeutics that they may not have had access to under a traditional model, and I think that’s just a win for everyone, really. So, that would be my sort of two key areas.

Arsalan Arif: Fantastic. All right. And the last word goes to you, Matty.

Matty Culbreth-Notaro: Well, I mean, my colleagues here, Erin, Kristen and Daniela, have really hit the nail right on the head. That is exactly the benefit, you know, all the benefits of the DCT. And just to add to that a little bit, I mean, our participants are our number one main priority, and it is the reason that we do everything that we do. But in addition to that, you know, we also want to make projects much more efficient, you know, much more efficient, cost efficient, and just overall efficiency, so when we’re able to, you know, achieve database lock just 10 days after last patient out, that’s huge efficiency right there. That’s amazing. That’s cost efficiency. When we’re able to recruit the participants and complete them, you know, until the very end, that’s efficiency and cost efficiency. So, you know, the participants benefit, and the clients benefit, which means the overall world benefits because now we have all these research trials and drugs coming to market and devices coming to market that much quicker with real-time data, and everybody wins.

Arsalan Arif: All right. Thank you so much. That’s all the time we have for today, and it was a fantastic panel. I want to thank you to everyone in the audience for sharing some of their time with us today, and thank you to all my expert panellists for sharing your knowledge with us. I’m Arsalan Arif for Endpoint News. A copy of this webinar will be made available on demand, and thank you to Novotech for bringing this topic to our audience. Thanks everyone.

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