By Deborah Borfitz

July 1, 2021 | At the DIA Global Annual Meeting yesterday, Medable presented on its recently established digital certification program for decentralized clinical trials (DCTs) intended to provide life science companies with the design tools and knowledge to scale their study strategies with more of the DCTs “building blocks”—ranging from televisits and eConsent to medication distribution and home nursing and labs. The technology and training are all anchored by the Medable platform, which has already been deployed in more than 150 fully and partially (hybrid) DCTs.

The new program incorporates an academy offering “robust training” on the essentials of DCTs and enables companies to build studies on the Medable platform using established tools, according to Andrew MacKinnon, digital trial operations lead. The academy can assist in both the building of DCTs and teaching CRAs and site startup staff how to work with them.

Another program component that will be built out are communities of researchers, sites, and organizations who will support one another to “get the best at designing, transforming, and innovating within the DCT space,” continues MacKinnon. Medable’s concierge service will ensure everyone involved—be they patients and sites or sponsors and their various study partners—has the right level of support, he adds.

In the broader marketplace, Medable looks to “break down the silos in scientific development and make sure digital clinical innovation is available on a global basis,” MacKinnon says.

The academy has three tiers that sit atop the foundational Medable platform, he explains. The first is specific to the design of DCT solutions using out-of-the-box tools, with organizations having the latitude to incorporate their own build and design standards and efficiencies into the process.

Organizations may also wish to transform themselves by partnering with Medable to create more customized study designs and seamless study experiences, says MacKinnon. A third option is for organizations looking to scale rapid, autonomous innovation across their enterprise where they might design their own applications or integrate existing ones and move into more complicated areas such as digital endpoints.

As indicated on the Medable website, four digital certifications can be earned as part of this scaling exercise:

• Digital Foundation, providing an overview of digital screening, electronic clinical outcomes assessment, eConsent, televisits, and remote patient monitoring;
• Digital Analyst, designed for clinical operations and project managers, which is focused on how to implement DCT best practices and shared expertise to reduce cycle times and improve patient access and experience;
• Digital Architect, enabling data managers and clinical operations professionals to design and build digital trials that optimize study design, reduce site burden, and provide engaging patient solutions; and
• Digital Engineer, for advanced technical experts who want to configure DCT solutions to enhance data quality, improve study start efficiency, and configure purpose-built solutions on the Medable platform.

Fact sheets are available for sponsors and CROs on the Medable website that cover the course modules for each of these certifications.

The Roadmap

The new certification program acknowledges that “no one size fits all” in terms of the study protocols suitable to the decentralized approach as well as system readiness to take them on, says MacKinnon. Even just remotely screening and consenting patients can have huge dividends for companies in opening access to trials and simplifying participation, as suggested by research in California finding that the average journey to oncology studies for patients is 25 miles in each direction—and in some cases three times that long.

A Deloitte study has also shown that more than 70% of patients in the U.S. live more than a two hour’s drive away from a clinical research center. The benefit of using televisits and eConsent is that they facilitate “a greater level of patient engagement, retention, and diversity with clinical trials,” he says.

From there, trial sponsors might systematically move up the DCT ecosystem with the addition of data collection methodologies such as eDiaries or more validated digital assessment tools for patient-reported or clinician-observed outcomes. The next step might be to start integrating those data collection tools into the Medable platform for integration with lab or other clinical data or connected sensors for remote patient monitoring with anything from an Apple Watch to more advanced ECG devices.

At the fully decentralized stage, services like direct-to-patient drug shipment and home nursing enter the picture, all aimed at reducing the burden of trial participation on patients and sites, MacKinnnon says. “Not every protocol is going to require a full DCT ecosystem.”

2030 Vision

As envisioned by the Clinical Trials Transformation Initiative, the ecosystem in 2030 should feature five key elements, says Chief Scientific Officer Pamela Tenaerts, who participated in the visioning exercise. Studies should be patient-centered and easily accessible (i.e., DCTs and hybrid trials), fully integrated into healthcare processes (no “extra parallel systems on the side”), designed with a quality approach, maximally leveraging all available data (from sensors, electronic health record, and claims), and improving population health.

“We need to get to trust with this new methodology,” Tenaerts says, by ensuring patients are safe, the data used are reliable, and processes fit into currently available workflows (or everyone is on board with the new ones). Common ground language is also needed because the technology and medical worlds use some of the same words but to express different meanings.

The term “decentralized clinical trials” appears to have made the cut, she adds, including with regulators.

With people, the big challenge is a “lack of understanding of the innovation,” says Tenaerts. This includes the identity of the audience, the people who work in this new world, and how to embed new processes in their work.

Another major challenge is operational and process integration, such as how to do eConsent in new ways and understanding where to start. With technology, the big barrier is the financial resources needed. This is where decentralized solutions can flexibly meet the need, says Tenaerts, noting that companies do not necessarily have to contract everything out.