As we embark on another exciting year for the digital health landscape, I wanted to take a moment to reflect on the strides our industry has made, particularly in the field of digital measures for clinical research. The past twelve months have been marked by several key advancements, which were only possible through the determination, dedication, and hard work of our digital health community.
1) Regulatory Acceptance of Digital Health Technologies (DHTs): Perhaps the most noteworthy achievement of 2023 is the growing regulatory acceptance of digital measures as endpoints in clinical trials. Regulatory agencies have recognized the potential of these technologies to capture richer information on patient functioning, enhance patient-centricity with low-burden technology, and collect new types of measures that inform meaningful aspects of health.
FDA acceptance of a primary digital endpoint for the first time in a phase 3 pivotal study by Bellerophon Therapeutics, as well as the EMA primary endpoint qualification of stride velocity in Duchene's Muscular Dystrophy are reflective of regulators being open to the value digital measures can add to clinical research. And just last week, the FDA published the final guidance "Digital Health Technologies for Remote Data Aquisition in Clinical Investigations,” outlining potential benefits of DHTs and recommendations to facilitate their use in clinical trials.
2) Precompetitive Collaboration Among Biopharma: The collaborative efforts within the biopharmaceutical industry have been inspiring, particularly in driving innovation within the digital health space. This was clear to me as the industry came together to share ideas, new data, and lesson learned at events such as CNS Summit and PanAgora Pharma's Digital Implementation and Digital Biomarker Summits. We look forward to continuing these types of discussions at the upcoming ActiGraph Digital Data Summit 2024.
This collaborative approach not only accelerates the development of novel solutions, but it also fosters an environment where shared insights can propel the entire industry forward. We are honored to lead a collaborative effort like this with our DECODE Nocturnal Scratch project, a cross-industry working group to generate a validated, regulatory-approved digital measure of nocturnal scratch to advance dermatology research and accelerate novel treatment development for these patients.
3) The Rise of Novel Digital Measures: Wearables and other digital tools are now capturing a broader range of real-world, objective data, providing a more comprehensive view of individual health and treatment outcomes. With the 2023 launch of our next generation multisensor wearable, ActiGraph LEAP, we’re positioned to help drug developers and clinical researchers capture more types of data to advance our understanding of human health. Throughout 2024, we’ll continue to expand sensor functionality to offer new and enhanced digital measures, such as skin temperature to improve sleep detection and PPG measures to better inform physical functioning.
4) Continued Focus on Patients and Patient Centricity: DHTs offer the opportunity to better serve patients by collecting objective data on meaningful aspects of health, especially in areas with a high unmet need. This is one of the reasons we launched the Digital Endpoint Accelerator Research (DEAR) Grant initiative, to fund leading researchers who are filling evidence gaps to develop novel digital measures in areas such as chronic heart failure prevention, detecting fall risk in older adults, and sleep patterns in down syndrome.
Another benefit of DHTs in clinical research is to reduce burden in patient populations that already experience intense treatment schedules. Two examples with new evidence to support this concept in 2023 include measuring disease progression in ALS and assessing physical activity in oncology trials.
As we celebrate these achievements, we remain committed to pioneering what is possible in the realm of digital health technology for clinical research. Our team is dedicated to providing cutting-edge solutions that empower researchers, enhance patient experiences, and contribute to improving human health. We look forward to another year of collaboration and innovation as we collectively shape the future of clinical research.
To learn more about using wearable digital health technology in your research, reach out to your ActiGraph account manager or contact us today.
