Digital health technologies (DHTs) are revolutionizing the landscape of clinical research, pushing us toward more innovative and patient-centered trial methods. It’s an exciting time, with technology opening doors to new possibilities and ways of understanding health. Keen to dive deeper into this significant shift, we met Christine Guo, ActiGraph‘s Chief Scientific Officer. With her deep dive into the field, Christine offered us an insider’s view of the powerful impact these technologies are having right now, the challenges that come with such rapid innovation, and a glimpse into the promising future of clinical trials. Her insights highlight the path forward and the potential for these technologies to transform patient care and research outcomes.

Moe: What unique advantages do digital health technologies bring to clinical trials, especially in challenging areas like neurology and rare diseases?

Christine Guo: DHTs, especially wearable devices, are revolutionizing how we approach clinical trials by offering unprecedented insights into patient health outcomes in real-world settings. In areas like neurology and rare diseases, where traditional clinical evaluation methods often miss the subtleties of day-to-day patient experiences, DHTs are filling critical gaps. These technologies allow for continuous, real-time monitoring of patients, providing a rich, objective data stream that captures the variability of symptoms and disease impact outside the clinical environment.

For example, in neurology, wearable devices can meticulously track movement disorders, offering detailed analyses of symptom patterns over time. This is invaluable for understanding diseases like Parkinson’s or epilepsy in depth. Similarly, in rare diseases, where patient experiences can vary widely, DHTs offer a way to collect consistent, objective data on how conditions affect individuals in their environments. This direct measurement of patient experiences supports the development of treatments that significantly improve quality of life, aligning with regulatory focuses on patient-centered outcomes.

Moreover, the continuous data flow from DHTs enables early detection of changes in disease progression or treatment effects, facilitating more responsive and personalized care strategies. By bridging the gap between clinical observation and everyday realities, DHTs not only enhance the precision of research but also ensure that trial outcomes are deeply relevant to patient needs, driving forward the development of impactful therapies

Moe: How do early discussions with regulatory bodies like the FDA influence the development and selection of digital health technologies?

Christine Guo: Early engagement with regulatory bodies such as the FDA plays a pivotal role in developing and selecting DHTs for clinical trials. By initiating dialogue at the outset, sponsors and researchers can align their design and implementation strategies with regulatory expectations, which is crucial for navigating the complex approval processes. These proactive discussions help clarify the regulatory landscape for innovative technologies, particularly how new types of data collection, like that from wearables measuring physical activity, can be integrated into clinical trial designs to serve as meaningful endpoints.

Christine Guo Chief Scientific Officer ActiGraph

For instance, when sponsors present their plans to use wearable devices for continuous monitoring of physical activity in a trial, regulatory agencies can offer valuable feedback on the validity and reliability of the data collected. This interaction ensures that the technology meets stringent regulatory standards and guides the refinement of trial designs to focus more sharply on outcomes that matter. It facilitates smoother regulatory approvals by preempting potential issues and aligning the technology’s capabilities with the regulatory framework. Moreover, these discussions can lead to a more effective trial design by identifying the most relevant and impactful endpoints from the outset, thereby enhancing the potential for successful outcomes. Through this collaborative approach, regulatory agencies become partners in innovation, helping to steer the development of DHTs in a direction that maximizes their benefit to patients while adhering to the highest safety and efficacy standards.

Moe: Can you discuss the operational challenges of integrating DHTs into clinical trials and strategies to overcome them?

Christine Guo: One of the primary operational challenges is ensuring patient adherence to DHT protocols across diverse and global trial sites. To address this, we’ve focused on developing devices that are not only user-friendly but also minimize the need for patient intervention. For instance, devices with extended battery life and capabilities for passive data upload significantly reduce the burden on participants. Moreover, our ActiTrack solution provides real-time adherence data, allowing timely interventions to maintain protocol adherence.

Moe: With the rise of decentralized clinical trials, what role do you foresee for DHTs, and how can they address the current hesitancy among Big Pharma?

Christine Guo: DHTs are inherently aligned with the ethos of decentralized clinical trials, offering capabilities for remote data collection that can significantly enhance trial accessibility and participant diversity. While there’s a noticeable hesitancy among some pharmaceutical companies, primarily due to concerns around data reliability and regulatory acceptance, the benefits of DHTs in reducing patient burden and improving data quality are undeniable. As regulatory bodies evolve their guidelines to accommodate DHTs, I believe we’ll see an increase in their adoption, driving the decentralization of clinical trials.

Moe: Given the potential of DHTs to transform clinical trials, what steps do you believe are necessary to foster their broader acceptance and integration into research methodologies?

Christine Guo: To truly embrace the potential of DHTs and integrate them into research methodologies, we first need to deepen our engagement with regulatory bodies. It’s not just about initiating dialogue but maintaining an ongoing conversation to ensure the regulatory framework evolves alongside technological advancements. This step is crucial for creating a supportive environment where innovation thrives while safeguarding patient safety. By working closely with regulators, we can develop clear guidelines and standards that make it easier for researchers to adopt DHTs confidently, knowing they meet regulatory expectations.

Furthermore, education plays a pivotal role in broadening the acceptance of DHTs. There’s a need to illuminate the capabilities and benefits of these technologies across the board—whether it’s pharmaceutical companies, healthcare professionals, or patients themselves. Showcasing real-world examples where DHTs have enriched clinical trials can dispel doubts about their efficacy and reliability. But beyond just highlighting successes, fostering collaborative initiatives is vital. When technology providers, researchers, and regulatory bodies come together, it sparks innovation and leads to developing best practices for DHT use. These collective efforts are essential for accepting DHTs and fully integrating them into the future of clinical research.

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.