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Decentralised Trials, Technology & Patient Engagement: SCOPE Conference 2021:

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Decentralised Trials

Our Executive VP for the Americas, LaQuinta Jernigan, co-presented with Eric Mayer, CEO of EDP Biotech, at the Cambridge Healthtech Institute SCOPE 2021 Summit for Clinical Ops Executives.

Eric and LaQuinta’s presentation focused on Decentralised Clinical Trials, Technology & Patient Engagement. They discussed how innovation, including home healthcare, home testing, telehealth and wearables, can reduce patient burden and lead to more successful trial outcomes.

You can now watch the presentation from the conference in full, or read the transcript below.

Watch the video:

Read the Transcript:

LaQuinta: 

Hi, everyone. We’re pleased to have you join us for an important discussion on the importance of decentralized clinical trials, and how we can use technology to improve the overall patient experience and increase patient engagement. My name is LaQuinta Jernigan and I am the Executive Vice President for the Americas at mdgroup. 

mdgroup is a leading global provider of personalized clinical trial solutions. And our mission is to make life better for patients taking part in clinical trials around the world by delivering remarkable services.

Eric: 

My name is Eric Mayer, and I’m the CEO of EDP Biotech. We’re a diagnostics company that sponsors clinical studies, including now several decentralized studies, as well as a study site for sponsors looking to enroll patients in the southeast and Appalachia region.

LaQuinta: 

We already know that there are many demands that a clinical trial will put on patients. And today they demand more of patients than ever. Especially in light of living through a pandemic and trying to navigate healthcare needs in the midst of COVID-19. Many of these demands require the patient to go through additional hoops and hurdles to meet the commitments that are required for clinical trials.

The time commitment for clinical trial has to often be juggled with their jobs, with their family lives, and maybe even childcare needs. There are also travel constraints. Not many patients live within 30 minutes of a site. Some have to drive two hours each way to get to their clinical site, or even fly. Travel can be a difficult barrier for patients to overcome because it adds to the time commitment issue, and also presents a financial impact on patients.

Eric: 

That’s absolutely correct. And I think now, during this entire pandemic experience over the last year, decentralized trials are more important than ever. In fact, there was a recent study by Oracle Health Sciences that just came out. It showed that 76% of respondents have accelerated their decentralized trials during the time of COVID. And, of course, for sites and sponsors like us that are trying to get out to a patient that may be out of the Appalachian region, two to three hours away from a traditional study site, a decentralized trial is definitely the way that we can approach those underserved communities.

LaQuinta: 

And when we talk about supporting those underserved communities, and even regular communities, that are already included in many of our clinical trials, it would be naive of us to not consider the challenges that lead to patient drop out. Because, at the end of the day, we have to retain patients that we recruit into our clinical trials.

We already know what some of these common challenges are, they’re sitting here in front of you on the screen. The great thing about decentralized clinical trials is that they address many of these issues. And while we’re addressing these issues, we are removing some of the same barriers that exist for minority populations that prevent them from participating in clinical trials. So, taking a DCT approach to your clinical trial is a huge win – not only for patient retention and engagement, but also for any diversity initiatives aimed at increasing minority population participation in clinical trials.

Eric: 

We’ll talk about this a little bit more in the upcoming minutes, but there are so many new technologies and platforms that are available to provide outreach to the patient to give them reminders about appointments, or to send a healthcare provider into their home, or to liaise with that patient through telehealth. Infrastructures, systems and platforms are now catching up to the need to deploy these clinical trials in either a fully decentralized or even a hybrid manner.

LaQuinta: 

And that takes us to our next slide, which is a perfect segue to talk about some of the benefits that decentralized trials brings to our industry. When we talk about the benefits, it’s important for us to ask ourselves the question, why is this so important? Why are we talking about it?

We’ve talked about the fact DCTs help with engagement and retention, but why is that? Recent studies targeting patient populations that are participating in clinical trials show that 70% of patients live more than two hours from a research site. So, when we talk about rural locations, and when we talk about underserved communities, this is something that can’t be ignored.

In 50% of clinical trials, participants find it difficult to stay enrolled due to poor health. So now we’re talking about patients who are enrolled in a clinical trial, but they’re not feeling well. It’s cumbersome for them to leave their homes and go to their site visit, even if it’s just one visit a month. And then if you have a higher frequency of visits, where you’re going twice a month, or even every week, it can become very, very difficult for a patient who’s feeling ill to make those commitments.

And then, 85% of trials fail to retain enough patients. That’s a really critical piece, because retention is such a huge issue for our industry. A lot of money is spent on retention efforts to make sure that we keep those patients. And when we’re talking about a rare disease, it’s even more important and critical to keep those patients retained in your clinical trial.

This is why this conversation is important, and this topic is so important, because decentralized trials have the primary goal of making clinical trial participation as easy as possible, by enabling participants to continue with their day to day lives with minimal disruption. It’s important to look at ways we can integrate these solutions into our clinical trials.

When we look at the benefits a little deeper, one of the strongest benefits is that DCTs bring more options to patients. This is going to increase participation because it puts the emphasis on the patient experience and improving accessibility and convenience for patients’ participation.

Home Health is a great example of this. When you’re looking at your overall study design, it’s important to ask: “Can I complete any of these visits by utilizing fully qualified HCPs to visit the patient to administer medication, perform tests, or obtain samples to allow the trial to progress without a site visit?” And if the answer to that is yes, then it’s absolutely something that should be implemented.

Having in-home health care allows patients to reduce their travel burden, to reduce their financial burden for participation. And it also allows them to have a little bit of a say in how they participate within the clinical trial. Some patients will opt to have home health for all of their visits if they could, but some might have specific visits that they would just rather do in their home. Either way, it gives them that choice and that convenience, to participate in this way.

Eric: 

And I think that that patient engagement, and empowering the patient, is extremely important with all of these new types of platforms. When the patient has more control over when they can set their appointment, if they can have someone come to them, or even do it through telehealth on their smart device, it gives them more control over their daily lives. It engages them to stay enrolled in that trial.

From a site or a sponsor standpoint, we always want to make sure that we’re looking into the rules, regulations, licensures of these health care providers. If they’re going on site and going to patient homes and doing those types of visits, you want to make sure that you’re working with healthcare provider groups that have the remote capabilities, and that have the training, because it’s a different bedside manner going to see patients at home rather than seeing them in the clinic.

But there are all kinds of technologies and devices out there that allow these trials to continue. I think the most exciting ones coming up are the wearables and sensors. That’s everything from patches that can be placed on the patient, which can track heart rate or muscle contractions — we now even have noninvasive blood glucose meters without a finger prick. There are pill cams in different types of sensors that can be ingested and take real time data, and report that data in real time to the healthcare provider or the physician monitoring the patient.

And we can also do a lot more remote safety monitoring in real time. Obviously, when we bring a patient into the clinic, we’re introducing some inherent bias there that you’re not going to see in a real-world use case. So, this remote tracking, these remote wearable sensors, and this remote safety monitoring really gives trial investigators insight into what’s going to happen when that drug or device is deployed out in the field.

LaQuinta: 

And that’s such an important factor. We wouldn’t have the ability to have real world data without decentralized trials. So, instead of us looking at DCTs as something that we’ve ‘had to do’ – because of the pandemic – we should embrace them as a way to get truer data, to have better predictive analysis for how our solutions are going to actually impact society.

And now we’ll move on from the patient to the sites, because the beauty of a DCT approach is that it also can reduce burden on sites. Right now, we’re all too familiar with the overwhelming situation that our sites are faced with due to the pandemic. Many of them are experiencing staffing shortages, they don’t have enough research staff to conduct all of the visits and do all the work that trials require. They’re struggling.

When we look at a DCT approach, we can remove some of that burden from those sites by simply taking some of the visits from the site and putting them in the patient’s home. That allows the site to be able to focus on enrollment, which can lead to greater enrollment, and faster enrollment, if they can have that resource available to them by conducting some of the visits in the home.

Eric: 

And we’re seeing that right now. As many health care providers are starting to focus more on, for example, vaccination efforts related to COVID, most of their resources are being pushed into that bucket. We don’t have the resources available to enroll patients and have those patients come into the clinic.

So, what we’re seeing is the acceleration of these decentralized trials, getting more patients to enroll in a virtual setting, or more referrals within networks of healthcare providers. In the southeast we’re seeing networks of laboratories, big and small, running all the labs and even imaging centers around the southeast, where data can be sent digitally, reviewed by that healthcare provider, and then results delivered electronically.

All of these new networks that are being built help reduce the burden on one specific central site – spreading the resources out, making sure you can get to the patient, engage with the patient, give them the standard of care that they need, and also collect the data that you need to complete your study.

LaQuinta: 

It’s important to also point out that by bringing these resources to your trial, you’re able to reach more local sites, sites that might be very specific to minority communities. And so, we go back to the diversity initiative, the idea of bringing more diverse populations into clinical trials, because that is such an important initiative that our industry is focusing on right now.

Oftentimes, we’re missing these minority groups because we’re not going into those communities. We’re not working with their local community clinics and hospitals, because we might feel that they’re too small, or they may not have the support and infrastructure in place to conduct clinical trials. But if we’re able to alleviate some of the duties from those sites, we’ll be able to utilize more of them and therefore increase our diverse pool of participants for our clinical trials. So, that’s another important factor to keep in mind. 

Eric: 

And having that friendly touch, that local touch, even if your study is being conducted from a long distance, really gives the patient a comfortable feel – a familiarity and trust that they would not have had otherwise.

LaQuinta: 

Next on our list, as far as benefits are concerned, is patient engagement.  Now, patient engagement is something that is of the utmost importance. We know that when patients are engaged, we’re able to retain them more successfully in our clinical trials.

When we’re talking about decentralized clinical trials, patient engagement is also key. To have that patient engagement, you have to use technology effectively to increase the paths of communication.  As decentralized trials come into play, as we take hybrid approaches, or even in some cases we go fully virtual with our trials, it’s going to become more common that technology is going to replace in-person communication. 

That’s when we talk about telehealth and using that technology and platforms to communicate with patients. When we’re coming into the home of a patient, we can absolutely still have that interaction with the PI even though there’s a nurse conducting that visit from the home. We just have to make sure the right technology is in place. This can also help with streamlining consenting.

Eric: 

Absolutely. Now that we’re adopting more of these decentralized and hybrid models here at EDP, we’re seeing a lot of the IRB reviews go through, which is obviously a very important regulatory consideration. 

A lot of the communication with the FDA and other regulators is being done virtually and the same is starting to happen with the consenting process. All of your informed consent, all of your patient data tables, that can all be done electronically now. You can still maintain HIPAA compliance, but get that information over to the patient, explain the trial to the patient, explain the follow up and obtain their consent in a much more efficient manner.

And that helps the patient to understand what you’re doing and how the follow up is going to take place – and they get that engagement we’ve been talking about this entire time. So, you get efficiency built in, you get improved participation. And you are also able to get this done in a remote, tight manner.

We’re talking about getting options to the patient, empowering them in getting the data that you need from a study standpoint, and getting the patient the care that they need, and deserve as well. There are just so many more options in going decentralized or going to a hybrid-type model, which can get the local providers involved, and can get patients more engaged.

LaQuinta: 

And let’s not forget also that decentralized research typically leverages available technology that really can help recruit a more broadly representative population. We’re looking at gender, ethnicity, geography, income – really reaching across all those different levels and bringing them in using technology that wouldn’t necessarily be utilized in a traditional clinical trial. 

So, we’ve talked about the benefits of a decentralized clinical trial approach, and how introducing technology can aid enrollment and increase patient engagement and retention. But we have to take some key considerations into mind when it comes to introducing different technologies into your clinical trial.

One of those considerations is digital education. It’s important to ask ourselves the questions: Do I need to explain how this technology is going to work to my patients? Is the technology intuitive? Most patients will require some sort of human touch when it comes to introducing new technology. It’s not helpful to introduce new technology to your patient population with just an instruction manual. Some will get it, but most will not. It’s important that patients have a single point of contact to go to, someone who can assist them with understanding the technology and how it works and troubleshooting if there’s any issues with it. We’re talking about diversity again here, because you have to consider education and health literacy levels when you’re talking about technology and how it’s going to work within your clinical trial.

We also need to consider patient expectations of technology. We are all digital consumers. Most patients are going to have preconceived notions of how technology works and should work. They’re going to have experience using smartphones and apps and Bluetooth devices. With this experience, there’s a level of expectation that comes with it as far as how tech works, how reliable it is, how easy it is to operate.

When you’re introducing technology into your clinical trial, ask whether it will meet some of the expectations that participants may already have of using technology. Are the patients going to be required to use their own devices to make this tech work? Are they going to need Wi-Fi capability to make the technology work? It is never safe for us to assume that all patients are going to have access to devices or Wi-Fi. So, this is something you have to think about when you’re designing your clinical trial and make sure that you have contingencies in place to support every patient from every walk of life, so that no patient is locked out because of their lack of resource.

Eric: 

Absolutely. And I think this really drives home the point that decentralized trials are not all or nothing. They don’t have to involve the most fancy, high-end, brand new technology either. Some patients just want to be interacted with by a simple text message. There are different ways we can outreach to these patients and get them involved at their comfort level and their level of tech education.

When you’re starting a DCT or amending a protocol to include some type of hybrid approach, think about how you’re going to integrate and interface with all of these new types of technologies. There’s a lot of proprietary platforms out there. You have to be able to get the data in and out of these systems, and in and out of lab systems and imaging center systems, and then get it up to the regulators.

So, one of the things you really want to consider ahead of time is talking to regulators, talking to your review board, talking to the healthcare providers, talking to your vendors, and your logistics coordinators who may be delivering materials, drugs and things like that to the patient’s home. Make sure you’re selecting outsourcing partners and third parties that have the right experience, and start that conversation early, so you have nice smooth protocols going at the same time without a hitch.

LaQuinta: 

Absolutely, technologies integrating with one another is so important – not only for our patients, but our sites as well. If we can make sure that different technologies and platforms integrate, then that will prevent patients from having to work within several different platforms. It will also prevent sites from having to log into multiple different platforms for one trial.

The great news is that most technologies do work on systems that can be integrated. We just have to be able to have that open communication with our with vendors and other third parties to make sure that everyone understands how the tech can work together.

And that concludes our presentation. Thank you so much for taking the time to watch, and we hope you found it insightful. We truly believe this is the future clinical trials, and we’re very excited to see what lies ahead.