Clinical Researcher—October 2024 (Volume 38, Issue 5)

TRIALS & TECHNOLOGY

Robin Harris

 

 

 

The integration of digital tools has brought better efficiency to clinical trials. Among these innovations, wearable devices are changing how data are collected, monitored, and analyzed. A growing shift toward digital endpoints paired with the widespread use of wearables has opened new avenues for real-world and more patient-centric data collection. The use of wearables also changes how study teams interact with their participants. Here, we look at the increasing role of wearables in clinical development, exploring their impact, benefits, and what they mean for researchers.

Growing Adoption of Wearables in Clinical trials

The increased use of wearable devices in clinical trials has coincided with improvements in their capabilities in recent years and the growing demand for more patient-centered assessments in development programs. Wearables like smartwatches and fitness trackers have allowed programs to monitor physiological parameters continuously. They place little to no burden on trial participants and provide researchers with access to more complete health data, tracking heart rate, blood pressure, glucose levels, and physical activity. They can also offer digital measures of sleep, mobility, and additional vital signs, including oxygen saturation and skin temperature.

Wearables collect data away from clinical settings, offering a more accurate assessment of patients’ daily lives and reducing the need for frequent in-person site visits. They collect high volumes of data that provide a clearer picture of a specific medical condition than previously achievable using more traditional methods. Multiple studies using wearables have also shown high patient adherence of between 70% and 80%.

Better Insight into Diseases

Wearables are used in many medical conditions, especially in managing chronic diseases where continuous monitoring can provide a clearer picture of the lived experience of affected patients. In respiratory diseases, tracking physical activity and coughing symptoms can help researchers monitor idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease.

Devices are being used to evaluate neurological conditions such as Parkinson’s disease, where tracking symptoms such as tremors, gait disturbances, and sleep disruptions can be unreliable using in-clinic and at-home diary methods. Wearables can monitor movements and sleep disturbances, giving researchers better data on symptom fluctuations.

Using wearables to monitor activity levels and sleep patterns is also helpful in understanding the impact of novel weight loss medications. By capturing data on participants’ physical activity and sedentary behavior, wearables can contribute to a more accurate assessment of change while receiving these treatments, helping researchers to better demonstrate and provide evidence of treatment efficacy.

Enhancing Engagement and Data Quality

Wearables can help keep participants engaged in a study for the duration of a clinical trial. They reduce the requirement for frequent in-clinic visits and make it easier for individuals to stay involved for long periods, if needed. Once a participant wears a device, the data immediately stream in, allowing researchers to monitor compliance in near real-time. This continuous engagement offers a much-needed opportunity for longitudinal programs that require consistent and robust data collection to assess the long-term outcomes of treatments. The wear periods for wearables can also be tailored to capture data at specific times. This could be around dosing or when a change in activity is expected.

Wearables enable trials to benefit from a round-the-clock assessment of participants rather than relying on periodic snapshots. This can ensure fluctuations and trends are identified that could easily go unnoticed using different tools.

Impact on Clinical Research Sites

Adopting wearables in clinical trials not only provides many advantages regarding data quality and efficiency, it can also bring certain additional considerations for research sites. While introducing unfamiliar steps may initially seem burdensome, multiple device assignment workflows can be tailored to meet a study team’s specific needs and streamline the inclusion of wearables. This helps to minimize the demands on researchers’ time. Electronic step-by-step guides are also provided for all workflows.

Researchers will need to become familiar with the software and be able to assign wearables accurately. They will also be required to fully understand the benefits of the devices and be comfortable with the study design, as they will be responsible for communicating this information to participants. Additionally, they will monitor wear compliance and ensure participants have all the necessary tools to maintain adherence.

Researchers will also be required to consider the visit structure and wear periods. Higher compliance is typically achieved when participants leave a site already wearing the device for the prescribed period.

Transitioning from traditional methods, such as patient questionnaires, to wearable-collected data can reduce the workload for researchers at clinical sites. While this shift decreases the time spent on manual data entry, wearables also present unique challenges.

One challenge is effectively communicating the value of participation to study participants, who are often blinded from their activity data to avoid influencing their behavior. This can make it challenging to demonstrate the value when participants are unaware of the science behind the data and the changes being captured. Study teams must clearly articulate how wearables contribute to the advancement of the trial and the improved understanding of the participant’s disease.

The Future of Wearables in Clinical Research

Wearable technology in clinical trials is helping to improve how data are collected and used to support a study’s aims. Real-time and continuous monitoring offers development programs and study teams valuable insights into participant health, helping to enhance the accuracy of clinical trial outcomes and broaden understanding of many different disease areas. Integrating wearables in a study design can allow more people from broader geographies and varying backgrounds to access a clinical trial.

As clinical research moves toward more siteless or hybrid models with fewer in-person visits, there is a need to adapt to this by incorporating greater functionality through mobile apps and cellular data hubs. We are now seeing more data to support new wearable device capabilities, including battery life and data storage, verifying their use for extended wear periods.

The ongoing validation of wearables in clinical trials will continue to change how we design and conduct drug development programs, making studies more patient-centric and contributing to better insights. They hold the potential to improve not only how we collect data from participants, but also the type of data we collect and how we can use those data to inform the development of better treatments.

Robin Harris is Vice President of Client Services 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 in clinical trials. With extensive trial project management experience, she has a deep understanding of the complex operational challenges these technologies can introduce to a clinical development program, as well as proven strategies to successfully navigate this evolving landscape.