The DCT Network: When Experienced Providers Come Together, We Can Revolutionize Clinical Research

MaryAnne Rizk, PhD

Creating new medications and medical devices is an enormous endeavor. Traditional, randomized controlled trials require millions of dollars and thousands of people to get it right. Now, as decentralized clinical trials (DCTs) become increasingly preferred, there are new spokes in the wheel—i.e., wearable devices, home-health nurses, systems integrators. Clinical trials, now more than ever, take a village.

But operationalizing DCTs often requires a network of partners. When a group of expert providers come together to design and execute DCTs, sponsors, investigators, and patients all benefit. With a coordinated approach, the industry will accelerate this new model to make better medicines faster, safer, and more effective for every biology around the world and why we formed a partner network.

Medable vetted all members of its network as best-in-class providers to confidently connect sponsors with partners who already have experience and expertise running decentralized trials. While sponsors are not required to work with our partners, it is to their advantage if they do. Any ecosystem of experienced, like-minded organizations adds value and simplifies the complexity of running a DCT.

“There are a lot of moving parts in a DCT, but you cannot have 300+ points in a value chain because that creates transactional inefficiencies and impossible-to-manage complexity,” explained Avi Kulkarni, VP and Life Sciences R&D Lead at Cognizant, a systems integrator. “On the other hand, one company cannot possibly innovate at every part of the value chain, so a limited ecosystem of best-in-class partners provides sponsors with the right balance of skill sets and manageability.”

The key five components of a successful DCT network include:

• Service partners – CROs and systems integrators provide outsourced expertise for trial deployment, project management, and support. Leading consultants also bring specialized expertise in decentralized and hybrid trial deployment, study management, data analysis, insight generation, site relationships, and process optimization.
• Data partners – enriching clinical trial data with real-world data is pivotal to accelerate effective therapies to patients faster to create a holistic profile of the patient and provide solutions for long-term follow up post trials. Connected data partners make it easier to incorporate real-world health records, claims, diagnostic, and other data sources with trial data. This reduces the burden on patients and helps trial teams augment evidence before, during, and after studies.
• Technology partners – when leveraging a variety of software, data, and wearable/connected devices, ensuring interoperability across systems is critical to providing a seamless data flow and experience for sponsors, sites, and patients.
• Direct-to-Patient partners – these organizations enable a patient concierge experience with home health nursing, and at-home testing, sample collection, and diagnostics. They also improve patient enrollment and foster new biomarker discovery while reducing patient burden. Vault Health, which sold more than 10 million COVID-19 tests for at-home use, is one example.
• Site partners – site partners can include traditional sites and academic institutions as well as non-traditional retail pharmacy locations, such as CVS Health, to expand clinical trial access and engagement for patients from distant clinics to nearby communities.

Services partners: Providing strategic expertise

CROs play a central role in most clinical trials, and when they can draw on the talents of a partner network, a better outcome can result. For instance, Noolie Gregory, vice president of DCT Operations at Syneos Health, noted that study setup can involve an elaborate negotiation with the study sponsors themselves. A coordinated approach can simplify this and address the sponsor’s specific needs.

“When we come together as a connected ecosystem of value-add partners, we can offer sponsors reliable, validated choices—the right technology, tools, and whether we need to focus around eCOA or need integrated wearable devices or is it to visualize data in a new way or map specific KPIs…that is where a partner network offers great benefit,” said Gregory. “We can start solving on a portfolio level rather than project by project.”

For companies that prefer an enterprise wide DCT approach, which calls for additional expertise, a network of partners proves particularly crucial to success. “We are working strategically with companies who want a holistic DCT strategy across the organization to find the right approach sensitive to their pipeline, their therapeutic focus, and their culture,” explained Gregory. “It’s a transition—everyone is at a different point on the change management curve. There are early adopters and laggards who are less certain. A trusted partner network gives sponsors greater confidence wherever they are on the curve.”

Data partners: Creating seamless data integration

The fragmentation of health data is one of the greatest challenges facing healthcare today. Patients have dozens of interactions with healthcare systems throughout their lives, and that information is retained in siloed databases across disparate institutions. With clinical trials being one of the most critical sources of evidence on drug effectiveness and safety, it is imperative to bridge the gap between clinical trial data and real-world data (RWD) to expand and extend trial value. DCTs naturally foster more RWD from various connected devices and wearable sources that, when combined with other clinical trial data, provide higher fidelity of efficacy and safety.

“Trials represent just a sliver of the data that describes patient health,” said Vera Mucaj, Chief Scientific Officer of Datavant. “Linking electronic health records and mortality data can support long-term safety and effectiveness measurement. Connecting insurance claims can add evidence of cost-effectiveness. And, connecting real-world data to DCTs augments trial evidence at a fraction of the cost of collecting data through a traditional clinical study.”

When specialized data providers are part of a connected ecosystem organized to facilitate easy data access and sharing, it is possible to seamlessly incorporate patient health data sources like electronic health records, and RWD into the trial. In this way, sponsors can optimize protocol and study design by adding richer clinical details about patients’ health. Better information available in real time also helps ensure participant retention the duration of a trial because it empowers study teams with the information to expedite any necessary patient support

Tech partners: Ensuring interoperability across systems

DCTs often require multiple systems across the value chain, but the greatest value comes when these systems are connected in a vetted ecosystem of providers that already have an in-depth understanding of the many nuances in the life sciences industry. For patients, system interoperability simplifies the remote clinical trial experience. For investigator sites, it simplifies their workflow and provides a consolidated, single source of truth with real-time access and single data entry (avoiding redundant work for staff). Finally, sponsors benefit with improved compliance and increased data quality with a streamlined workflow plus complete visibility into all activities across studies.

As an example, Medable and Oracle Health Sciences have developed data and workflow integrations between Medable’s eConsent, eCOA, ePRO and TeleVisit applications with Oracle’s Clinical One platform, simplifying trial deployment and providing high levels of flexibility and choice for sponsors and CROs. The Clinical One system brings together various data sources—including sites, eConsent forms, wearable sensors, patient apps, EHRs, and labs. This also enables all partners to make better decisions through access to hundreds of data types from extensive external sources across interactive response technology (IRT), EDC, clinical trial management systems (CTMS), custom systems, and more.

“Being part of a partner ecosystem streamlines decentralized trials and puts the patient at the center of the trial while providing robust data analysis for sites that can unlock better insights and ultimately better outcomes for sponsors,” said Henry McNamara, senior vice president and general manager of Health Sciences business unit at Oracle.

Direct-to-patient partners: Providing the human face of DCTs

The organizations that engage in direct patient interaction are on the front line of trials and crucial to the success of a DCT. They are the human face of what can seem a cold, sterile process so it’s important to align with partners with shared goals for patient care.

“We do much of the hard work of the clinical trial,” said Alexander Pastuszak, MD, PhD, President, Clinical Care and Chief Clinical Officer at Vault Health. “We interact with the patient via telehealth or at home. We support DCTs with specialized services that fill the gaps of commonly used digital technologies, doing this at scale through clinical study staff and the technology that supports them. For instance, we can provide investigators and virtual sites for studies and send clinical practitioners to do in-home patient assessments and collect diagnostic samples, and then ensure those samples get to the right labs, quickly and efficiently. As a part of an ecosystem, we capture these interactions and the data that goes with them in a single system that informs the rest of the trial.”

Pastuszak continued, “A DCT partner network is hugely valuable to sponsors. It streamlines the number of different vendors down to the very best few, simplifying trial management complexity, but still providing sponsors with choice. In addition, it allows sponsors to fill in the gaps by engaging a network of best-in-class capabilities to optimize the trial process. At this point, a single entity that tries to provide all DCT services will only have a mediocre result and that benefits no one.”

Site partners: Improving patient access and experience

DCTs expand site access by connecting patients with remote sites, offering easier ways to collect patient data, and bringing the on-site experience home using telemedicine. However, it’s critical to empower sites with customized training modules and best practices to expand decentralized trial knowledge. For starters, it removes much of the friction that comes with change management.

The value to all

A collaborative network, rather than any one company alone, allows sponsors to scale their strategies to put patients at the center of care. Best-in-class partners provide differentiated value through strategic alignment across therapeutic areas; preconfigured solutions for faster go-to-market delivery; technical enablement for user adoption; and trial design innovation.

Of course, partner networks are not a panacea—they can be set up well or poorly, and coordination can vary. But when there is a reliable technology platform that interfaces smoothly with both the technology and human elements of trial management, there is great potential to leverage all the advantages of DCTs. It also adds layers of new insights for continuous improvement as the industry continues evolving the DCT model. In other words, done right, a network improves the trial experience for all.

MaryAnne Rizk, PhD, Chief Strategy Officer, Medable