Contributed Commentary by Robin Harris, ActiGraph 

March 15, 2024 | Wearable devices are helping to transform the way clinical development programs are conducted, offering an innovative approach to data collection, patient monitoring, and endpoint measurement. The seamless integration of wearable technologies into trials requires meticulous consideration across various operational aspects. 

Device Suitability 

Selecting the right wearable device for a clinical trial involves thoroughly assessing multiple criteria. Ease of use is crucial for site personnel convenience and ensuring participant adherence through user-friendly interfaces. The device’s capacity to capture high-quality data and deliver reliable outcomes is equally imperative. Raw data capture and accessibility to this raw data should also be an early consideration.  

Aligning the chosen wearable with trial objectives requires proactive engagement with the technology vendor. Collaborating with a preferred vendor from protocol inception can ensure harmony between trial necessities and device capabilities. Because wearables come with significant variability in design and data collection methods, selecting a technology that matches precisely with a trial’s specific endpoints and objectives is crucial to success.  

Data Comparability 

The successful inclusion of wearable devices into a trial protocol requires careful consideration of how the data will coexist with other types of clinical data. With each DHT data collection point accurately timestamped, the overlay of wearable-generated data with other datasets provides a comprehensive view of the participant. Collaborating with the study team to align sensor/device data with other clinical data is crucial to ensure a complete picture.   

This holistic approach optimizes data collection and will elevate trial efficiency while enabling richer and more easily accessible insights that will advance the quality and reliability of research outcomes.  

Patient Engagement and Adherence 

In clinical trials, expecting participants to perform multiple daily steps can challenge their commitment. Incorporating a wearable device and mobile app facilitates routine passive data uploads, lightening the burden on participants. Educating both sites and participants about the intrinsic value of wearable technology in contributing to study goals and broader healthcare objectives, with minimal effort required, can significantly bolster adherence. Additionally, offering patients tangible outcomes, like personalized report cards at the trial’s end, can serve as a rewarding takeaway, reinforcing their participation and highlighting the impact of their contribution. These strategies may help to mitigate adherence hurdles, fostering a collaborative and engaging environment that amplifies the success of trials integrating wearable technology.  

Logistics and Support 

Managing wearable devices in clinical trials poses diverse logistical challenges. A critical issue revolves around timing wear periods, especially when confronted with a high percentage of screen failures and limited participant visits. For instance, if wearables are allocated at baseline for pre-treatment data collection but encounter a high screen failure rate, retrieving these devices without burdening patients with multiple visits becomes a logistical puzzle. Addressing this complexity involves defining minimum baseline data needs and potentially incorporating a second screening visit.  

Another logistical hurdle concerns the wear schedule. Requesting a pre-visit device wear is burdensome compared to post-visit wear periods, where patients leave equipped with the wearable. Moreover, managing device inventory levels, particularly if a limited number of devices are leased and must be shipped back to the vendor for cleaning and redeployment, can cause redistributive delays, impacting trial timelines.  

Ensuring a seamless patient experience using wearable devices requires sites to be trained and equipped with troubleshooting expertise. When a higher level of technical support is needed, direct vendor communication becomes essential to ensure uninterrupted device utilization and maintain patient engagement. This collaborative approach between sites and vendors is crucial to sustaining device functionality, ultimately enhancing wearable-enabled trial efficiency.   

Data Management and Analysis 

Managing the substantial data generated by wearables within a clinical trial demands a customized approach. The handling procedures significantly differ based on the nature of the wearable-generated data, distinguishing between primary and exploratory endpoints.  

Data stemming from primary endpoints typically undergoes frequent scrutiny, warranting consistent evaluation. In contrast, data related to exploratory endpoints may arrive intermittently in less frequent batches, allowing for varied handling protocols.  

Furthermore, the frequency of receiving processed data as opposed to raw data plays a pivotal role in effective management. Processed data is often acquired more frequently and requires immediate analysis and monitoring. In contrast, access to raw data might be deferred, usually provided as an archive package at the culmination of a trial. This stratified approach enables continuous critical data evaluation while preserving the comprehensive raw dataset for in-depth post-trial analysis and validation. 

Sensor-based DHTs inherently present greater complexity compared to traditional clinical measures. To maximize the utility of DHTs and understand how best to manage data, collaboration with multi-disciplinary teams, including engineers, data scientists, biostatisticians, and clinical scientists, should be considered essential. This collaborative approach ensures the practical application of DHTs to address clinical hypotheses and unveil clinical insights that may otherwise go unnoticed.  

Cost and Resources 

Assessing the cost-effectiveness of integrating wearable technologies involves strategic considerations. Rather than treating wearables as optional additions when the budget does not allow for all sites, a more cost-effective strategy involves integrating them as dedicated sub-studies for specific trial sites. This approach can ensure that the investment in wearables becomes a guaranteed asset rather than a discretionary expense, maximizing their value within the trial.   

Efficient device management demands a comprehensive allocation of resources. This entails securing a complete package from the vendor, including dedicated project managers, proficient data operations specialists, easily accessible support staff, and a team of scientists. This approach ensures the essential financial and personnel resources are in place to oversee the incorporation of wearables, thereby streamlining operations, safeguarding data integrity, and maximizing the insights gleaned from the trial.  

Valuable Lessons From Previous Trials 

Reflecting on past trials involving wearables offers invaluable insights that can shape current best practices. One crucial lesson centers on the timing of wear periods, emphasizing the need for meticulous planning to synchronize with patient visits and reduce disruptions. Another vital learning discourages treating wearables as optional components, highlighting the benefits of integrating them comprehensively throughout the entire study or as dedicated sub-studies. Simplifying protocols emerges as a key takeaway, aiming to avoid unnecessary complexities that hinder trial execution and patient adherence.  

Furthermore, adopting a best practice approach entails early collaboration with the mentioned multi-disciplinary team of scientific experts during the protocol design phase. This proactive step ensures harmonious alignment between trial objectives and the capabilities of wearable technologies. 

Final Thought 

The integration of wearables calls for strategic device selection aligned with trial objectives. It involves balancing technological compatibility, patient engagement, and logistical hurdles like timing of wear periods. The importance of simplicity, meticulous planning, and early engagement with vendors cannot be overstated for biopharma companies contemplating using wearables in their clinical trials. These factors are crucial in optimizing trial design, ultimately underlining the study’s success and efficiency.   

Robin Harris is the Senior Director of Digital Health Operations at ActiGraph. Since joining the company in 2015, she has played an integral role in the development of key internal processes to help operationalize digital health technologies (DHTs) in clinical trials. With extensive trial project management experience, Robin has a deep understanding of the complex operational challenges DHTs can introduce to a clinical development program as well as proven strategies to successfully navigate this evolving landscape. Born and raised in Pensacola, FL, Robin has a BS degree from the University of West Florida. In her spare time, she enjoys spending time with her family, working out, and scuba diving in tropical locations. She can be reached at robin.harris@theactigraph.com.