The Impact of Wearables in Clinical Research: Q&A with Jeremy Wyatt

Jeremy Wyatt
CEO
ActiGraph

The technology that goes into wearable health monitoring devices has advanced by leaps and bounds in recent years, particularly on the consumer side. Jeremy Wyatt, CEO of ActiGraph, spoke with Pharmaceutical Executive about the impact these devices are having on clinical trials.

Pharmaceutical Executive: How are wearables changing patient monitoring in clinical research, and what specific benefits do they bring?
Jeremy Wyatt: Wearables allow continuous, real-time data collection directly from the participant’s natural environment. This method of passive data collection is crucial, as it garners accurate and comprehensive health data while reducing the burden for patients to participate in trials.

ActiGraph’s wearables are designed to be discreet and user-friendly, emphasizing comfort and minimal interference with daily activities. This patient-centric approach ensures high compliance and longer-term data collection, providing a richer dataset for clinical trials. This consideration of design extends to ensuring that the devices are lightweight, ergonomic, and have extended battery life to minimize the frequency of recharging.

One of the standout aspects of ActiGraph’s technology is its application in gathering real-world evidence. Moving beyond the controlled confines of traditional clinical settings, these wearables are critical in understanding treatment efficacy in the dynamic environment of everyday life. This data is invaluable, particularly as the healthcare sector moves towards value-based care models that emphasize long-term outcomes.

PE: What are some of the perceived hurdles or challenges in adopting wearable technology in clinical trials?
Wyatt: Adopting wearable technology presents notable challenges that sponsors must address to leverage these tools' advantages fully. One primary hurdle is the necessity for sponsors to establish, adapt, and implement these technologies more broadly. This requires a shift from traditional methods to a more integrated approach involving collaboration with technology companies to ensure the seamless integration of wearable technologies into clinical research frameworks.

Another significant challenge lies in the legal framework governing these collaborations. The existing legal structures must be comprehensively revamped to facilitate smoother interactions between the pharmaceutical sector and technology providers. This would involve addressing data privacy, security, and compliance with regulations, which are critical when dealing with sensitive patient data collected through wearables. The current frameworks may not fully encompass the intricacies of digital data collection, necessitating updates to accommodate new technologies and methods of data handling and sharing entities. For wearable technology to be adopted more effectively in clinical research, there must be a concerted effort to foster cross-sector collaboration and update the legal standards that guide these engagements.

PE: In what ways do novel digital measures contribute to a deeper and more insightful understanding of the patient experience across different medical conditions?
Wyatt: The novel digital measures introduced by wearables are carving a path towards a more nuanced understanding of patient experiences across a spectrum of medical conditions. By integrating Digital Health Technologies (DHTs), researchers can delve deeper into participants' day-to-day health, providing previously unattainable insights. Wearables can also objectively track fluctuation in symptoms over time with more sensitivity than periodic, point-in-time measurements, providing a detailed map of how conditions evolve and respond to treatment.

In groundbreaking applications approved by the FDA, such as Bellerophon's phase III study of interstitial lung disease, digital measures have been used as primary endpoints. This shift highlights the capability of digital tools to deduct robust, reliable data that mirrors the real-life impacts of therapeutic interventions, often speeding up the research process and enhancing the accuracy of findings. The FDA’s recent release of its final guidance for using DHTs for Remote Data Acquisition in Clinical Investigations indicates that regulators are ready for more objective and consistent tools.

Beyond conventional metrics, these digital tools are venturing into previously challenging territories, such as analyzing sleep stages, measuring coughing frequency, and detecting nocturnal scratching in dermatitis. This expansion is critical, especially in these areas that are lacking patient-centric measures. The strategic application of wearables is bridging the gap between controlled clinical environments and the variable conditions of everyday life.

PE: Can you discuss the role of collaboration within the industry and how it’s driving advancements in using DHTs for clinical research?
Wyatt: The DECODE project, spearheaded by ActiGraph in partnership with pharmaceutical giants such as Johnson & Johnson, UCB, and Takeda, exemplifies the power of collaboration in pushing the boundaries of DHTs. This initiative focuses on developing a novel digital measure tailored to monitor nocturnal scratching among patients with eczema and atopic dermatitis. It aims to address a significant gap in current clinical research methodologies by providing precise, real-time data on a symptom that significantly impacts patient quality of life but is challenging to measure in clinical settings.

The collaboration goes beyond technology development; it is a concerted effort among some of the leading entities in healthcare to build devices and collect data that are directly responsive to patient health needs and will shape the future of how health conditions are understood and treated. These companies will accelerate innovation and create meticulously tailored solutions to enhance patient care by pooling resources, expertise, and technology.

Such pre-competitive collaborations highlight the industry's potential for shared knowledge and combined effort. By working together, these organizations can streamline the development process, navigate regulatory landscapes more efficiently, and deliver validated technologies and measures that set new standards in clinical trials.

This collaborative model also illuminates the industry's commitment to patient-centric care. These technologies ensure that clinical trials and subsequent treatments align more with patients' experiences and needs by focusing on real-world applications and patients’ everyday functioning. This approach enhances the relevance and effectiveness of clinical trials. It paves the way for more personalized and precise healthcare solutions, fundamentally changing how conditions are monitored, understood, and treated in the long term.