Enhancing Patient Engagement and Data Accuracy in Decentralized Trials

ACT: Medable has achieved impressive results, such as 90% eCOA adherence. How do you ensure such high levels of participant engagement and data accuracy in decentralized trials?

Mackinnon: On the customer value team that I run, there are three key pillars. I mention this because all three are crucial to delivering these kinds of results. My team has extensive clinical research experience. While we may not be the technology experts in the company, we deeply understand clinical research.

One of our groups focuses on product adoption, ensuring that our customers can effectively use the technology. Another pillar is therapeutic area strategy, which examines how our platform performs in different types of studies—whether in oncology, vaccines, or respiratory diseases. We consider the unique nuances of each indication and ensure that study designs align with the needs of specific patient populations.

The third pillar is our site and patient engagement team. We operate under the belief that successful studies require both supported sites and engaged patients. If either element fails, issues arise—often in the form of poor patient adherence and retention. Our site engagement team plays an integral role in all our product development efforts.

Recently, we’ve been re-envisioning how sites interact with our platform. This team has spent extensive time consulting with site staff, nurses, and research coordinators to understand their workflows and challenges. By doing so, we design solutions that genuinely work for them. Even though sites aren’t the buyers, they’re a core user group, and we must ensure our tools are intuitive and effective for their needs.

We apply the same level of engagement when working with patients. For each study, we consult members of our advisory council who have the relevant condition or a similar experience. We ask targeted questions: Would this study design present challenges? How does your condition affect daily life? What obstacles might arise in this workflow?

For example, we recently worked on a study for Sjögren’s syndrome, where fatigue is a primary symptom. Our initial design included compliance notifications prompting patients to complete tasks. However, patient feedback revealed that many wouldn’t be awake to see the alerts. Based on this insight, we adjusted the system—sending one notification earlier in the day and another mid-window when patients were more likely to be awake. This change significantly improved engagement.

We take a patient-centered approach, considering how they live, how their condition affects them, and how we can design studies that fit into their daily lives. Additionally, we ensure that notifications are delivered in the most effective format. A quick push notification might be dismissed immediately, whereas an email can be bookmarked and revisited later.

Our goal is to create a seamless, consumer-grade experience that makes participation easy and intuitive. When you combine clear communication with a frictionless user experience, that’s where the magic happens—it’s our "secret sauce." Many dropouts don’t occur because patients don’t want to comply; they drop out because the process is too burdensome. By reducing that burden, we ensure higher adherence and engagement.

Full Interview Summary: Key factors contributing to success include a strong customer value team with expertise in clinical research, not just technology. The team addresses product adoption, therapeutic area strategies, and patient engagement. A critical element for success is designing trials with patients’ daily lives in mind, ensuring that tasks are non-burdensome and easy to integrate into their routines. For example, in a study with patients suffering from extreme fatigue, notifications were adjusted to be more accessible by changing the timing to align better with patient habits.

Additionally, Medable has gained Canal approval for operating in France, overcoming previous barriers like stricter data protection regulations. This approval enhances confidence in using electronic consent (e-consent) across global trials, improving data security and participant benefits. Furthermore, advancements in AI and tools like Medical Studio are transforming trial operations. AI speeds up tasks like building eco instruments, reducing weeks of work to minutes, and offers solutions to challenges like language translation for global trials. With digital platforms, the company enables broader, scalable approaches for clinical trials across various therapeutic areas. This shift from pilot studies to large-scale implementations aims to enhance trial efficiency and cost-effectiveness across entire portfolios, rather than focusing on individual trials.

Lastly, regulatory bodies are adapting to decentralized trials, with the EMA and FDA releasing new guidelines that support the integration of digital solutions. Despite some regulatory discrepancies, such as the stricter Canal regulations in France, the industry is moving toward broader acceptance of decentralized trials, ensuring that digital tools are compliant with data security and privacy standards. This approach promises to reshape clinical trial methodologies, making them more efficient and accessible globally.