Clinical Operations and DCT Tech Merge for Better Patient Oversight

Gillian Livock

Noolie Gregory

Syneos Health and Medable recently partnered to offer comprehensive technological and clinical operational support in clinical trials. In this interview, Gillian Livock, SVP & general manager, customer engagement at Medable and Noolie Gregory, VP of DCT operations at Syneos Health discuss how combining technology with clinical operations delivers better data and clinical trial patient oversight.

Moe Alsumidaie: How will the Syneos Health and Medable partnership take steps to bring clinical trials closer to the patient?

Gillian Livock: Our partnership is founded in our mutual effort to apply technology that supports patient engagement and reaches those patients that wouldn't normally be able to participate in research. We collaborate on how to best leverage the power of the Medable platform to keep patients engaged while collecting meaningful real-time, real-world data that gives sponsors actionable insights.

Noolie Gregory: Yes, absolutely. It’s about bringing the trial to the patient and ensuring they know they can participate in trials in different ways. Gill’s last point is key: the data we can generate because of these approaches is much more real-time. It's much more accurate and, therefore, can drive many more patient insights that we can garner.

The daily interactions patients have with the clinician in real-time tells you how the patient feels right here, not a recollection of what happened three weeks ago. This data that we generate is much more meaningful not just to sponsors but to patients as well. On the front end, we are improving accessibility; on the back end; we are generating better data that is more meaningful to the patient.

GL: That is the impact of our partnership. The collaboration doesn’t start when we get a protocol from a sponsor. Does it begin before we do critical pre-work to consider how to collaborate most effectively with sponsors to think about designing digital fit protocols? Syneos Health provides that medical and operational expertise, and we deliver the technology.

We think about how to design a better patient journey upfront. What does it mean to have to continue to visit sites every month for a patient for the next 12 months? How can we intelligently assess the data and the insights we need to collect to support this protocol in a way that reduces the burden on the patient and improves site effectiveness? We consider ways to screen patients remotely and reduce costs for sponsors. We look for unique ways to have ad-hoc communications with the patient through televisits. Together, it’s like a white-glove approach to patient engagement.

MA: At the recent DTRA meeting, regulators expressed concern about data fragmentation associated with DCTs. What oversight infrastructure and tools do you have to help integrate the data better to promote better study oversight?

NG: This is where the Medable platform makes a big difference because it is end-to-end. If you have e-consent from one source and wearable data from another, that can create fragmentation. Medable’s end-to-end platform enables a unified collection of data. The bottom line is that we can't sacrifice patient safety or data integrity, so we work closely to ensure that doesn't happen in our joint studies.

GL: It can be challenging for the industry to bring together siloed data sources and modular technologies. Our platform has been designed for interoperability from the ground up and to bring the core modules seamlessly together. At the same time, the platform can connect with other systems to unify the data streams and support a more holistic view.

MA: Thank you. Can you provide an example of a DCT where you work together, what aspects Syneos Health and Medable bring to the study, and where they overlap? How has the partnership benefited both parties?

NG: Sure, here is an exciting example of a 10-year follow-up clinical trial. As you can imagine, a lot of things happen to a patient in 10 years, so a decentralized approach is critical to capturing robust data over that long period while maximizing patient engagement and retention to get the endpoints we need.

In our partnership with Medable, Syneos Health serves as the CRO—so we are doing the site selection, site contracting, data monitoring, and pharmacovigilance. Medable provides the end-to-end technology backbone.

Again, where we have strived in our partnership is how we collaborate to continue to innovate, adapt, and remain focused on patients and customers to ensure we're meeting the needs of that sponsor. Medable and Syneos Health are in lockstep, working together to ensure a seamless experience.

GL: As Noolie mentioned, there are many challenges in such a long-term follow-up study. We needed to think about how to ensure the patient stays connected to the trial for a long time without being intrusive into their daily life and supporting our sponsors in collecting the meaningful data they need.

One way is to bring consumer-grade technology to patients they are familiar with—like how they use these tools for mobile banking and shopping. This is one way to reduce the burden of trial participation by making it easy. We can collect rich data about the patients via their internet connection or cell phone throughout their everyday life. The data is available in real-time so we can see whether the patient has completed a task, and if not, we can re-prompt them meaning we continue to collect valuable data when needed. The patients don’t have to remind themselves or visit the site continuously. We can follow these patients in a way that does not impact their lives but continues to allow the sponsor to get the information they need to support the study.

Patients know that, even with a long-term trial, they can easily continue and complete tasks digitally with limited impact on their daily lives. At the same time, sponsors are confident that their patients will still contribute data in line with their clinical trial requirements. This can also be more cost-effective when we eliminate multiple site visits.

MA: Thank you. So I understand that oncology is a therapeutic area that Syneos Health and Medable have collaborated on a lot over the past 18 months. Still, this area is often tough to decentralize essentially. Could you speak about the approach and working for oncology trials?

GL: At Medable, we think about the best way to digitize patient engagement and data collection. And oncology is a prime therapeutic area for our partnership with Syneos Health to make a difference because oncology is such a complex, lengthy, and arduous process for patients. We want to reduce the impact of multiple site visits and data collection points. We identify ways to minimize site visits by bringing a digital questionnaire, for instance, a patient diary or wearable that collects data remotely. The site, too, has visibility so they can monitor how their patients respond in between visits and contact them with our televisit module for pre-arranged or ad hoc engagement.

This is particularly important for some of these patients post-acute care when they're more comfortable being treated at home—having a digital framework and decentralized architecture allows patients to stay comfortably at home while giving investigators the confidence that they still have oversight of their patients.

NG: If you think more about Syneos Health’s decentralized capabilities—we even have a home health nursing service to provide in-home nursing for patients. That's a perfect example where you've got the digital backbone, but then you'll be able to support patients in their homes, even in person.

Remote screening and digital recruitment tools allow us to look for specific biomarkers in small patient populations. For example, if you're looking for a biomarker only prevalent in 10% of patients, sites are limited in their geographic reach, but a DCT opens the study to a broader population. For example, you can use digital advertising to identify patients and work with local providers or pharmacies to screen patients for inclusion/exclusion criteria. That benefits the trial because pre-screened patients know that they will be eligible when they go to their first site visit. Our patient concierge services help too.

MA: And presumably, the patients are more willing to participate in a study if they can contribute to the trials from their home or local clinic. Are there additional advantages of a DCT model for clinical research that may need to be more widely discussed?

NG: You started the question by saying that patients are presumably more willing to participate in a DCT than a traditional trial, but that is only sometimes true for all patients. Some patients prefer an onsite visit with their trusted healthcare professional. But, to answer the first half of your question, one of the most interesting additional advantages of a DCT approach is that there is much flexibility which yields creativity in terms of protocol design and solutions. By partnering with Medable, we have two great minds collaborating and thinking about novel ways to solve old problems using new technologies. This way of working opens doors to solutions that have never been considered.

GL: That is so true, Noolie. DCTs also offer the benefits of real-world evidence. Leveraging connected wearable devices and other technologies, we can now capture more real-life experiences around what patients feel in real time without overburdening them. Your data becomes much more patient-centric.

NG: And again, there are some operational efficiencies around remote monitoring. We need to monitor all of this data from the patients. We need to check for compliance. We need to check for anomalies and trends. Being able to do that in a decentralized trial where you have data held within the Medable platform allows us to do that more seamlessly.

GL: When we think about our partnership governance, we find areas where we can bring operational effectiveness and efficiencies. For example, aTufts Center for the Study of Drug Development study shows that, on average, DCTs can achieve net financial benefits ranging from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million ROI and $39 million ROI, respectively.

MA: What are some of the difficulties typically involved with executing a DCT?

NG: The biggest challenge for me is change management—getting people to change their mindset and thinking. Many companies say they want to push the boundaries, but then they want 15 case study examples of a study done in that therapeutic area.

We have learned a lot but still need to learn. As an industry, we need to work together. Earlier, you mentioned DTRA, of which we are both members, and this is a way where we're trying to make sure we deliver change as an industry and build that confidence around the innovation.

MA: From a clinical operational standpoint, what are some of the challenges you've been through?

NG: In some disease areas where patients need high-touch, concierge-like services, there can be some unique challenges. And there are always some things to work through with software, but that’s just a standard aspect of delivering new software.

GL: There are a few classic issues to manage, like language translations. We have worked hard to manage all those translations across 60+ languages. Delivering clinical trials is challenging under any circumstance, so you need solid partnerships with experienced companies. More recently, and from a broader industry-wide challenge, we've seen a movement away from the slow study-by-study approach to a more scalable enterprise-wide approach like the work we are doing with GSK.

There will be country-by-country challenges, whether regulatory variability, different data security considerations, or device choice limitations. Syneos Health and Medable have successfully worked together to identify such challenges on a global scale and looked at ways to navigate that risk.

NG: One more point—we have a strong feedback loop, so all lessons learned are being applied again and again in future studies. We are growing and learning together for the benefit of patients, sponsors, and the industry.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.