Wearables in clinical trials

The use of wearables has shown considerable growth in recent years. More and more people own smartwatches, fitness trackers, and other wearable devices. According to research from ROCK HEALTH, more than 40% of consumers track their health data with wearable devices.

While most devices are marketed as lifestyle gadgets to track the fitness and wellness levels of consumers in everyday life, these devices are equipped with powerful sensors that pose great potential for clinical trial research. According to CLINICALTRIALS.GOV, as of 2021, there are more than 900 trials utilizing wearables, with over 300 of them completed.

The promise of the technology: to enable objective 24/7 health monitoring while significantly reducing the cost of data collection. This change would enable more research opportunities and ultimately could lead to an increase in innovation.

Wearable technologies improve data quantity and quality

To provide meaningful and accurate results, clinical studies need access to considerable amounts of patient-related health and physical data. More often than not, subjects have to be monitored over prolonged periods.

One way to help better understand a treatment’s efficacy and effectiveness is the collection of health outcomes directly reported by the patient who experienced them. They are usually recorded through a questionnaire and due to their nature, can be inaccurate, subjective, and sporadic.

A more objective approach is the recording of physical health data on trial subjects. In the past, this could only be done via regular examinations by physicians in study centers or clinical facilities.

This approach not only entails high costs and creates many inconveniences for study participants. For patients, every trip to a clinical facility is an exertion that they should be spared whenever possible. This underlines the need for a paradigm shift to models using wearable devices, enabling a more remote approach for clinical trial settings.

Furthermore, physical examinations only provide very limited snapshots of a person’s phenotype and physiology. Bias can also be introduced by the stress that some patients may experience from these visits. Whitecoat hypertension (WHT) has been scientifically proven and is a phenomenon in which some people in clinical settings exhibit a blood pressure level above their normal range due to anxiety.

Real-world data recorded by the patient

Wearables have proven as a sufficient alternative to fragmented health monitoring from physical examinations. Sensors built-in off-the-shelf wearable can provide 24/7 granular data streams on patient’s health and activity levels. Not only does this provide a much more holistic picture of the subjects’ physical condition but the fact that recordings are taking place in real-life situations often makes it much more representative than data from physical examinations.

“Previously wearables were viewed as niche and the value hadn’t been established or perceived to be worthwhile. Now, we’re seeing the use of wearables to manage patients in their home environment outside of the clinic as having huge value”, says Marie McCarthy, senior director of product innovation at ICON Pharmaceuticals, to PHARMAVOICE.

Wearables offer a wide range of different biomarkers to be measured. Most devices support the measurement of activity, steps, and heart rate. Many recent generations can also monitor sleep, stress, and oxygen saturation of the blood, while some can detect more exotic markers like risk for atrial fibrillation.

A large number of these Biomarkers have long played a central role in the medical context for health assessment. And sensors are getting more accurate by the day. LI, VAIDYA AND WANG, for example, were able to significantly outperform the traditional clinical approach (LACE index) for predicting clinical deterioration of patients using Fitbit data, together with machine learning models.

Wearables improve processes and reduce costs for clinical trials

Traditionally, studies are frequently faced with the challenge that measurements and patients’ adherence to study guidelines can only be evaluated when the study is ending. This can be a serious problem if it turns out there is inaccurate or missing data. Approaches using wearable technologies enable 24/7 data streaming which makes it possible to assess the progress of the study in real-time and, if necessary, intervene at an early stage.

Another critical factor for the success of clinical trials is the retention and dropout rates of patients. Regular visits for examinations put a great burden on patients, oftentimes leading to dropout rates of up to 30%. The costs of this increase cause delays and can render trials invalid. Keeping the effort for participants to a minimum by sparing them regular visits to clinical facilities, there is a chance to lower dropout rates and improve engagement, adherence to protocol, and the general experience for participants.

Additionally, the digital and remote nature of these approaches helps to reduce administrative burdens, may it be simplifying the management of patient cohorts, streamlining data storage and analysis, or providing information for subjects using messaging capabilities of wearables and smartphones.

These factors will in sum help to reduce the cost of clinical trials significantly.

Examples of wearable use in clinical studies

Roche has found considerable utility in the use of wearables for research on Parkinson’s disease. “[…] We found our active tests detect significant PD-like symptoms. Also, by passively collecting the raw data while patients just go about their daily activities, we had an enormous rich dataset that provided unique additional insights using machine learning. The study showed strong correlation between remotely collected sensor signals and in clinical assessments”, Dr. Christian Gossens, global area head of digital biomarkers at Roche told PHARMAVOICE.

Thryve is supporting Berlin’s University hospital Charité in examining the impact of behavior and sports therapy on tumor patients’ treatment results in a clinical study. For an unbiased assessment of activity, physical performance, and training sessions, passively collected data from wearables is crucial.

Another example is the utilization of wearable data to monitor and manage the global COVID-19 pandemic. Thryve built a “DATA DONATION APP” – a research tool – for Germany’s center for disease control Robert Koch-Institut. Wearable data from more than 500.000 citizens are analyzed for COVID-19 symptoms daily.

This unique approach was verified by a study published October 29 2020 in NATURE MEDICINE, where researchers used wearables to detect positive cases of the virus by monitoring changes in heart rate, sleep and activity levels. Thryve uses a similar approach for the identification of infections.

The future of wearables in clinical research

While the use of wearables in clinical trials is already happening, it is still in the early stages. In December 2018, the FDA introduced a new strategic framework to advance the use of real-world evidence to support the development of drugs and biologics.

Furthermore, FDA Commissioner Dr. Scott Gottlieb has STATED that leveraging real-world data to improve regulatory decisions is a key strategic priority for the FDA. Wearable sensor technology will power this change as the largest part of the patient health-related activity is happening outside of a hospital or a clinic, according to EHR intelligence.

KAISER ASSOCIATES AND INTEL, predict 70% of clinical trials will incorporate some type of wearable sensors by 2025. All signs indicate that wearables will play a central role in clinical research. “We are just starting to explore the potential of wearables in healthcare and this industry is poised to become much larger than the consumer wearables industry”, Geoffrey Gill, president of Shimmer Americas, told OUTSOURCING-PHARMA.COM.