In the rapidly evolving landscape of digital health technology in clinical trials (DHT), Jeremy Wyatt, CEO of ActiGraph, envisions a transformative future. ActiGraph’s strategic focus extends to leveraging wearable DHTs for more precise passive data collection from clinical trial participants to post-marketing surveillance and real-world evidence data collection, enhancing patient care across the clinical research landscape. Emphasizing the need to bridge clinical trials and real-world settings, Wyatt highlights ActiGraph’s commitment to regulatory compliance, patient-centricity, and innovative partnerships. Through a forward-looking approach, ActiGraph is poised to redefine the integration of digital health in understanding treatment impacts, prioritizing data privacy, and fostering collaborative innovation for a healthier future.
Moe: How Do You Envision the Evolution of Digital Health Technology in Clinical Trials Over the Next Decade?
Jeremy Wyatt: It’s clear that these tools are here to stay. At ActiGraph, we’re seeing use cases for DHTs expand into a broad number of therapeutic areas, especially areas with a clear gap in patient-centric, meaningful measures. The FDA’s recent release of their final guidance for using DHTs for Remote Data Acquisition in Clinical Investigations clearly indicates that regulators are ready for more objective and consistent tools. In addition, success stories like the agency’s approval of using a digital measure as a primary endpoint in Bellerophon’s phase III study of interstitial lung disease and the resulting reduction in the timeline indicate that sponsors and patients see the value. ActiGraph is keenly exploring the potential to extend the application of its technology beyond traditional clinical trials, particularly into real-world evidence collection and broader healthcare contexts. While the current focus is on clinical trials, ActiGraph strategically positions its technology as a crucial link between the controlled environments of clinical trials and the dynamic realities of post-market healthcare landscapes and real-world evidence data collection. The goal is to leverage DHTs to gather actionable insights into how treatments affect patients in real-world settings, especially as we see a continued movement towards payer-driven value-based care models.
Moe: Given the increasing importance of patient-centric measures, how does ActiGraph ensure that devices and data collection methodologies are patient-friendly and validated?
Jeremy Wyatt: In response to the growing need for patient-centric measures in clinical trials, we have adopted a multifaceted approach to ensure our devices and data collection methodologies meet the highest standards of clinical validity and prioritize patient comfort and engagement. Our dedication is to develop devices that integrate seamlessly into patients’ daily lives, minimizing potential disruption or discomfort. This includes creating lightweight, ergonomic wearables with extended battery life to reduce recharge frequency, ensuring continuous data collection without inconveniencing the patient, and enabling passive data collection. Furthermore, our collaboration with organizations such as the Digital Medicine Society is a testament to our commitment to
enhancing the usability and validation of our DHTs. These partnerships allow us to stay at the forefront of best practices in digital health, incorporating the latest insights and feedback from the medical community and patients into our product development process.
Moe: In the Context of Data Privacy, How Does ActiGraph Protect Sensitive Patient Data?
Jeremy Wyatt: Our approach to safeguarding sensitive patient data extends beyond mere compliance with regulations such as the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA). We implement state-of-the-art security measures across all phases of data handling, from collection at the wearable device level to the final analysis and storage. Encrypting data in transit and at rest and investing in advanced cybersecurity ensures that patient information remains secure and inaccessible to unauthorized parties.
We also maintain a dedicated team of cybersecurity experts who continuously monitor for potential threats and vulnerabilities. This team is responsible for conducting regular security audits and risk assessments and implementing necessary updates to our security frameworks. Additionally, through comprehensive training programs, all employees are educated on the importance of data privacy and the best practices for maintaining the confidentiality and integrity of patient information.
Moe: Can You Discuss a Recent Partnership That Exemplifies ActiGraph’s Approach to Collaborative Innovation for Digital Health Technology in Clinical Trials?
Jeremy Wyatt: The DECODE nocturnal scratch project exemplifies our strategic vision for collaborative innovation in DHT to advance clinical research methodologies. By joining forces with pharmaceutical giants like Johnson & Johnson, UCB, Takeda, and other key players in the healthcare industry, we are developing a novel, wearable-based solution specifically designed to measure nocturnal scratching among patients suffering from eczema and atopic dermatitis. This initiative not only showcases the potential of DHTs to fill critical gaps in clinical research but also highlights the importance of cross-sector pre-competitive collaboration in developing innovative and directly responsive technologies to patient needs.
We can build novel and validated technologies specifically for clinical trials through these collaborations. This allows us to offer a patient-centered approach to problem-solving and ensure that the resulting technologies are highly relevant to clinicians, patients, and regulators. Moreover, this approach emphasizes the broader applicability of wearable technologies in monitoring and understanding complex health conditions, potentially leading to more personalized and effective treatment strategies.
Moe: Looking Beyond Traditional Clinical Trial Applications, How Does ActiGraph See Its Technology Being Used in Real-World Evidence Collection and Beyond?
Jeremy Wyatt: Our commitment to advancing clinical trials through DHTs extends well beyond the confines of traditional methods. We envision a future where our devices play a pivotal role in collecting real-world evidence, providing invaluable insights into how treatments perform in everyday settings. This transition from controlled clinical trial environments to the broader landscape of healthcare delivery is critical for understanding the long-term effectiveness and impact of medical interventions on patient health. By leveraging our medical-grade devices, we aim to facilitate a deeper understanding of therapeutic efficacy in the real world. This approach supports the shift towards value-based care and empowers healthcare providers with actionable data to optimize patient care plans. This capability is essential for chronic conditions, where long-term management and monitoring are crucial. As we continue exploring the potential of our technologies in these areas, we are positioned to contribute to post-marketing surveillance programs and real-world evidence data collection.
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.
