The move towards decentralised clinical trials has been accelerated by Covid-19, and the tech that underpins remote trials is evolving at a matching pace. Clinical Trials Arena sat down with virtual research organisation (VRO) ObvioHealth to discuss its end-to-end platform and discover how technologies of this kind are disrupting the clinical trial space.
The pharma industry’s previously tentative uptake of decentralised clinical trials (DCTs) has been spurred on by the challenges presented by Covid-19 over the past year.
One company dedicated to facilitating this swift move to tech-focused trials is ObvioHealth, a global VRO whose next-generation platform is offering enhanced remote patient monitoring capabilities to support end-to-end DCT approaches.
ObvioHealth’s platform offers a tailored transition to tech for sites and sponsors, harnessing FDA-approved devices to collect continuous real-world data and an app reminiscent of social media platforms to engage and retain patients.
Clinical Trials Arena sat down with ObvioHealth CEO Ivan Jarry and chief technology officer Craig Gravina to discuss the benefits and challenges involved in the transition to digitally-enhanced DCTs, and the role that technology can play in collecting richer data and making studies better-optimised, as well as more accessible and transparent.
Kezia Parkins: Tell us about your new platform and how it is enhancing remote patient monitoring capabilities for DCTs.
Ivan Jarry: We’ve just launched the first study on our new platform and effectively we have built the capabilities not only to connect with multiple devices remotely and simultaneously but also to be able to interpret the data flow.
It’s a new way to read studies as suddenly you have a continuous flow of data. With that, you need to analyse and interpret the data from a clinical point of view to make sense of it, but also to anticipate any potential adverse events. The connectivity from the devices we use, coupled with our algorithm, allows us to interpret that data in real-time.
KP: Can you explain the journey of your end-to-end solution, from study design to data reporting?
IJ: For most of our clients, when they come to us for a DCT it is their first time and it is not something that they are used to. Therefore, an essential part of the process is adapting the protocol of the DCT and educating the client/sponsor on how to do it. An example of a typical protocol is a patient having to take a pill a day. This needs to be defined when you go into a digital format. Is a day from the moment you wake up to the moment you go to sleep? Is 1am the next day or is it still the same day because you went to sleep at two in the morning?
Then, once we have agreed on a protocol with the sponsor, we transform that into a set of requirements that helps us to configure the platform. The platform is also able to manage digital recruitment by placing ads online. From there we can pre-screen them online, and if they qualify, they’re then going to be able to download the app and consent to participate in the study. With our platform all of this can be done in a few minutes.
When a product, drug or device is shipped there will be a QR code to be scanned to make sure the participant receives it and we provide training materials such as on-demand videos that explain how to connect devices. Then we are ready to start intervention and can start sending out reminders and notifications for when a patient needs to take a pill, a picture of their skin or fill out a questionnaire. There is no need to navigate the app, it’s all automatically set up to fit where the patient is on their journey.
IJ: We looked at dozens of different partners and tested a lot of those devices to find the ones that would give us the most accurate data and would provide ease of use for patients.
We have been using products from these partnerships for around four weeks now and from the constant stream of data flow and the amount of vitals we are tracking, it is clear that we made the right choices.
These partnerships have opened a whole world of possibilities, where you can remove a lot of the site visits, where in these times of Covid, you want to avoid exposing people to the virus as much as possible.
The amount of vitals we can collect with these devices is really novel. There are a ton of companies creating devices to collect very cool data at an early stage and we are definitely looking at more partners to have more patches and wearables to collect a huge variety of data in real-time.
KP: ObvioHealth is working with RedHill Biopharma on a hybrid Covid-19 trial with a high level of remote at-home patient monitoring. How is this trial bringing together a lot of the technologies that ObvioHealth offers, and how important is it for you, as a proof of concept?
IJ: With this study there’s the one initial visit to the site – the first-time people are diagnosed with Covid. This is when they’re being offered to participate in the trial to test RedHill’s RHB-107, a Covid-19 treatment. So it’s very unique as a proof of concept that you can run a Phase II/III Covid study for sick patients entirely from home.
We bring a kind of small hospital setting into the patient’s home with these devices that are connected on a real-time basis. We also have nurses that are conducting home visits. All of the logistics are integrated in the app to connect the nurse network with the patients as well as the reminders and the calendars.
It took us a few months with the client to figure out how we could enroll people to get them the devices immediately. And we tried a lot of different concepts and ideas to get to the model that is already deployed and working.
KP: What kind of technology are you harnessing to monitor centralised and continued monitoring of data acquired from partner devices and your app?
Craig Gravina: We have developed our own remote patient monitoring platform that provides real-time vitals and behavioural data from medical devices as well as from other mobile modalities. The cloud-based platform enables multiple kinds of device integration and can leverage data directly from devices as well as through third-party cloud environments that device partners may be aggregating data from. We harmonise the different data formats and record them as outcomes.
KP: What are the major challenges involved in integrating clinical trial data from a growing range of sources in a cohesive way?
CG: The major challenges are primarily related to the lack of a single device in the market that can address the needs of all trials. In most cases, it requires a set of devices, and finding the right mix of devices with the best user experience for the study and participant currently requires both clinical and technical design efforts.
Harmonising that data – getting all these pieces to work together and ensuring they are integrated seamlessly with the application across all operating systems – is not always easy as each device has its own integration software. Different devices will have varied mechanics of collecting and interfacing and may also have different frequencies of updates. The challenge is to make these technical complexities invisible for the clinicians, patients and sponsors. That process of seamless integration has been critical to the early successes we’ve seen.
KP: What’s the wrong way to go about DCTs and incorporating more remote patient data – what situations do you work to avoid?
IJ: I think the wrong way is just copying what was done before. A lot of people who move into DCTs take the old model and add a layer of cost – which is the software – to enable tele-visits. So everything is done the same way but instead of seeing the patient in real life, you just see them online. You are actually losing there. It’s important to not just make it virtual, but more about how decentralisation can make the life of the patient simpler and aid in getting more accurate and richer data sets.
Adding an extra layer of technology can make things complicated, because you need to train your sites to use it to enable the decentralisation. I think this is the opportunity to rethink how we’re running clinical studies, the way we collect endpoints, and why we collect those endpoints systematically. We’re trying to educate our clients to see that we are not copy-pasting from the old protocol to the new. It’s not about taking the old form of questionnaire and putting them on a phone. Because it’s hard to read, too long and it’s not formatted the right way.
KP: What do you hear from trial sponsors about their needs when it comes to remote technologies and DCTs?
IJ: They want to be really sure about the accuracy of the data and that it’s the real patient and not the patient’s kid who is wearing the device.
These are the things we must reassure them of. If they have been running trials on sites for 30 years, they’re used to paying a lot of money to train employees to take the measurements that are now being done with devices by patients in their own homes. This is the type of education and explanation we need to give sponsors that are moving away from sites – it’s scary, it’s new, but if you do it well and have more measurements and real-world data, you actually have better representation of the effect of your drug on the patient.
KP: There’s probably a lot of variation between different companies that you’ve worked with?
IJ: I would say the larger pharma organisations are usually more risk-averse. They spend millions of dollars on trials and billions on developing drugs; it’s very hard to convince them to change as they are more traditional. For biotech companies, time is of the essence in the development, because their funding depends on that.
Then, you have a lot more companies in digital therapeutics and consumer health, which are a lot more cost-conscious. So cheaper solutions are important for those clients and consumers.