Leslie Pascaud

Digital transformation within the life sciences industry has triggered massive shifts in clinical trial operations. As a result, team member roles and functions are rapidly evolving at all stages of therapeutic development, particularly for organizations running decentralized trials (DCTs).

As the pandemic continues to accelerate the transition to hybrid and fully virtual trials, the need for specific competencies and mindsets to suit DCT business models is creating new challenges and opportunities in team building, training, and development.

ObvioHealth has been conducting decentralized and hybrid trials for almost five years, and thus has first-hand experience in the evolution of digital trial teams. We are a virtual research organization striving to deliver better clinical trial data while reducing the burden on patients. This mission, along with rapid sector growth, has attracted a dynamic team of young and talented individuals. In 2021, we onboarded 71 team members, mostly in product development but also in clinical operations, sales, marketing, and finance.

The industry’s transformation is driving a shift in the skillsets we need to design, recruit for, and operate studies. A raft of new clinical trial roles has emerged—from front-end developers to virtual study coordinators. Many of these roles require unique cross-functional competencies spanning clinical operations, project management, and software engineering. For example, clinical operations team members need to be able to optimize a study protocol for the virtual environment. To accomplish this, they must partner closely with software developers to configure the platform so that it can accommodate all necessary specifications.

These cross-functional roles require a departure from traditional, top-down working models. Those who have worked previously at large organizations with rigid structures have learned a form of risk aversion within this heavily regulated industry. They frequently carry these behaviors into their next roles. But, working in DCTs requires an openness to learning and a willingness to challenge the status quo. Our teams are developing technologies that augment the capabilities of clinical trial sites and patients. As they innovate, their expertise is also helping regulatory bodies to evolve certain guidelines and regulations that no longer apply in a DCT environment.

In our fast-moving environment, we make strategic decisions quite quickly and often need to pivot in order to seize opportunities, from new technologies to new partnerships or new geographies. We need to arbitrate wisely when weighing options so that we don’t run off in too many directions at once, striking the right balance between agility and strategic clarity. It’s critical to align departments often, so we can ensure the team is headed in the same direction. In this environment, the most successful team members must have the intellectual flexibility to pivot when necessary. They must understand the “why” behind a given process and to apply those principles in innovative ways.

To address the constant evolution in health and clinical research, companies may need team members to shift responsibilities—for example, moving from the Clinical Operations department to Product Development. Some team members at ObvioHealth have transitioned from running and managing trials for clients to designing the company’s app and trial platform.

While these roles might seem distant cousins, pivoting across functions has become standard, and even desirable, in organizations like ours. The industry requires adaptable talent. Lateral-thinking clinical researchers, when working within highly matrixed and cross-disciplinary teams, are in an excellent position to design effective products.

Team members who come to a role with previous experience bring with them the ability to tailor study protocols and design to meet sponsor objectives. One ObvioHealth colleague, Joshua Lowndes, previously managed projects for the National Cancer Institute at a publicly funded CRO. He joined ObvioHealth’s Clinical Operations department and now works in product tech.

Lowndes remarked on his career progression: “I joined the company as a scientist focused on publications and realized I needed to position myself for the next role, and this one happened almost as a lucky accident,” he said. “In my academic career, I designed and implemented studies. In my previous roles, when writing protocols, I’d always think about the participants and their needs. This job enables me to lean on that experience and perspective in product conversations. The opportunity to do that here, in a very intentional way, really resonated with me.”

Another colleague, Senior Product Manager Kamalia Sazali, has a clinical background and has worked in implementation, bridging the gap between science and real-world data. She recently transitioned into a new role developing ObvioHealth’s next-generation product and platform.

“This job is the furthest out of my comfort zone I have stretched in my career, but it’s the most exciting,” Sazali said. “We’re taking our learnings and improving the participant journey. We’re asking: Can we start with the tech and see how it improves the protocol and drives interactions and engagement? We’re taking a more product-driven approach that uses all of our clinical expertise.”

When parameters change over the course of the study, an experienced DCT team has the knowledge and flexible thinking necessary to pivot. In some cases, this may require changes in recruitment parameters. In other cases, the team may identify tools that can capture new endpoints and potentially lead to novel outcomes. Clinical research experience gives these team members a big-picture perspective on decentralized trials, enabling them to accelerate certain decision processes. Their access to real-time, granular data puts them in a position to capture insights that may influence a study’s direction. For instance, in a recent study, they were able to simplify and streamline an ongoing trial by reducing the number of outcomes captured through digital devices to make the study completion easier for participants. This willingness to challenge the status quo is key to success in categories like ours.

The benefits of varied experience and open-minded thinking are equally relevant for business development representatives who must have a deep understanding of protocol requirements but are also able to think outside traditional boundaries. The BD team plays a key role in working with clinical experts to design studies that integrate new digital instruments and processes that can more accurately capture data while addressing any regulatory hurdles.

Creating a participant-centric experience

Clinical expertise drives benefits for patients as well. Virtual site clinicians who have held previous roles at traditional sites know the importance of engaging with patients. Brick-and-mortar site clinicians have always assisted participants in person, but decentralized trials have introduced a new and burgeoning category of virtual support teams.

Ongoing support for participants makes DCTs feel more human. It’s essential to train and encourage team members to deliver a participant-centric experience, from study recruitment and eConsent to electronically reported patient outcomes (ePRO). But it can take time for some traditional CRO staff to adapt to the new model; they need to establish a new kind of connection to improve engagement, compliance, and adherence. Virtual teams are reinventing participant engagement for the digital environment through in-app chat platforms, texting, and even traditional phone calls.

Team members check in with participants to remind them of upcoming appointments and other study tasks, as well as to address questions and concerns, including whether participants can take additional medications. They tackle the full gamut of topics, from medical issues to logistical and tech troubleshooting. (While some people assume technology is the main source of questions, our experience proves the opposite. In many of our studies, the ratio of study-related to tech-related questions is approximately 5 to 1.) Ongoing support also helps to keep participants informed and motivated. It can close gaps in communication that often exist in traditional site-based trials, where participants communicate with clinical team members primarily during appointments.

Many tech companies have renamed the “customer service” function to “customer success,” and the latter phrase is apt for the role that DCT support teams play. Effective DCT teams stay engaged from end to end, ensuring both participant and sponsor success.

For DCT participants—who spend hours completing study tasks in a mobile or desktop app –user experience is critical. The most beautiful digital solution in the world is useless if it’s not grounded in scientific protocol and the participant experience. Designing an intuitive, user-friendly app is imperative to removing patient burden, promoting retention, and, ultimately, running a successful DCT.

Every step in the participant journey must be thoughtfully designed to improve engagement and to ensure consistency and data quality. Certain questionnaires, for example, must reliably fit across differently sized mobile screens. And every participant should see the same number of words per line of text to preserve the meaning of each sentence.

Even displaying the data on the sponsor-facing dashboard requires innovative design skills and an ability to visualize key metrics in an accessible way. This is where clinical operations and technology intersect around the theme of “human design.”

Here again, the industry is shifting toward stronger collaboration rather than product and clinical experts operating in siloes. The most innovative teams apply creative, data-backed design principles to deliver better experiences for participants, virtual trial support teams, and sponsors—all of which inevitably supports better trial outcomes.

The shifting roles within clinical trial teams underscores the constant evolution of decentralized trials to meet the needs of participants and sponsors, all while bringing new treatment options to market. Navigating this new workforce requires flexibility, creativity, and a view toward the future. While there is no playbook for defining the future of clinical trials, forward-thinking organizations have an opportunity to build flexible teams that will thrive through change—and driven individuals have career-defining opportunities to embrace new roles.

is the Chief Marketing Officer for ObvioHealth

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The need for specific capabilities to suit DCT business models is creating new challenges in team building, training, and development.

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