Points of View Status of Utilization of Wearable Devices in Drug Development
-Trend Analysis by June 2025 -Trend Analysis by June 2025

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The Office of Pharmaceutical Industry Research Mariko Togashi, Senior Researcher
The Office of Pharmaceutical Industry Research Natsuko Watanabe, Senior Researcher
The Office of Pharmaceutical Industry Research Makoto Edahiro, Senior Researcher

Summary

1. Introduction

In recent years, wearable devices have rapidly increased their presence in the medical and healthcare fields, and their use is expanding in the field of drug development. In clinical trials in particular, wearable devices are attracting attention as a means of continuously and objectively acquiring a variety of biological information obtained in daily life, and there are growing expectations for this technology to complement indicators that have been difficult to ascertain through conventional medical examinations and self-reports. These characteristics are now being introduced in earnest as contributing to the improvement of research accuracy and the construction of new evaluation methods. The Office of Pharmaceutical Industry ResearchIn OPIR Views and ActionsNo.63, we first surveyed and reported on the utilization of wearable devices in clinical trials for drug development. This report summarizes the situation as of the end of June 2025, based on subsequent technological developments and accumulated examples of implementation in clinical settings.

As the performance of wearable devices has improved, their role in clinical trials has expanded, and the purposes and methods of utilization have diversified. While the possibilities for unprecedented forms of evaluation and data collection are expanding, there are still some issues to be addressed in their utilization. Against this background, this report presents the latest survey results and specific examples of utilization, clarifies the progress and significance of utilization, and provides an overview of future prospects.

2. status of utilization of wearable devices in clinical trials

OPIR Views and Actions Using the same method as in No.63, we surveyed the extent to which wearable devices are utilized in clinical trials of pharmaceutical products. In this survey, we selected from among all trials registered on ClinicalTrials.gov as of the end of June 2025, based on the following conditions.

Based on these conditions, trials that utilize data acquired by wearable devices were selected, and furthermore, trials with a "Start Date" before the end of 2025 were included in the analysis, resulting in 118 applicable trials.

ClinicalTrials.gov is a database of clinical trial registries and results managed by the National Institutes of Health (NIH). Clinical trials conducted in the U.S. are required to be registered, while trials in other countries and registration by pharmaceutical companies are voluntary.

Note that since this survey is based on a word search for "Wearable," trials that do not include the word even if they utilize wearable devices are not extracted, and the overall number of trials may be limited.

2-1 Survey result "Number of tests conducted per year

In this section, we counted the number of cases for each year listed as the "Start Date" of each trial for the 118 clinical trials extracted (Figure 1).

As shown in the previous OPIR Views and ActionsNo. 63, trials using wearable devices were first detected in 2016; a significant increase in the number of trials was observed in 2019, confirming their continued use since then. In 2025, a further increase in the number of registered trials is observed, albeit for a limited period until the end of June, so the trend of utilization should continue to be monitored closely.

2-2 Survey result "Implementation Phase

Figure 2 shows in which phases of clinical trials wearable devices are used.

The most frequently used was Phase 2 with 38 cases (up from 12 cases reported in the previous survey), accounting for 36% of all trials utilizing wearable devices (out of 105 trials excluding 13 Not Applicable cases), which is higher than the percentage of Phase 2 clinical trials as a whole (30%). Phase 4 was next with 30 cases (up from 14 previously reported cases), accounting for 29% of all wearable device utilization trials and higher than the proportion (22%) of all clinical trials. On the other hand, Phase 3, which is the key to drug application, showed an increase in the number of cases from the previous report (from 6 to 11), but was limited to 10% of all trials utilizing wearable devices, which is lower than the percentage of all clinical trials (17%).

2-3 Survey result "Conducting Entity

Figure 3 shows the number of clinical trials conducted by entity.

The largest number of cases was 68 in Other, followed by Industry and Other/gov. Compared to the previous report, the use of wearable devices in Phase 2 and Phase 4 increased (from 3 to 17 and from 3 to 23, respectively), while the use of wearable devices in Industry increased the most in Phase 2 (from 7 to 19). No significant increase was observed in the other phases.

2-4 Survey result "Country of implementation

Figure 4 shows the number of clinical trials conducted by region.

The United States had the largest number of trials (68), followed by Europe (21) and East Asia (12). The United States was followed by China (7) and Canada (6). The other countries ranged from 1 to 4 cases each. As noted earlier, the United States requires that clinical trials be preregistered with ClinicalTrials.gov in order to submit a drug application to the FDA, so interpretation of the number of trials must be kept in mind. According to ClinicalTrials.gov, the percentage of registered trials that include the United States is ^32%2), and from this percentage, it can be said that the number of trials utilizing wearable devices in the United States is large. On the other hand, the number of trials in Japan was only one trial led by Kyoto University, which was conducted on Alzheimer's disease, as reported in the previous issue of OPIR Views and Actions. This indicates that the use of wearable devices in clinical trials in Japan has not progressed well. In addition, 21 countries were registered in this survey, compared to 10 countries in the previous report, indicating that the use of wearable devices is expanding worldwide.

2-5 Survey Result "Target Diseases

Figure 5 shows the results of clinical trials conducted using wearable devices, organized according to the International Classification of Diseases, Tenth Edition (ICD-10) (Table 1).

The disease area in which wearable devices were most frequently utilized was G: diseases of the nervous system (39 cases). This was followed by F: mental and behavioral disorders in 14 cases and I: diseases of the cardiovascular system in 14 cases. As for individual diseases, as in the previous report, many trials were conducted for Parkinson's disease and heart failure, and several trials were conducted for various cancers, COVID-19 post-acute syndrome, obesity, and other diseases, indicating that wearable devices are being used in a wider range of diseases.

2-6 Survey result "Measurements

Figure 6 shows the measurement items by wearable devices.

The largest number of measurements was 39, which were related to sleep. Most of the measurements were for evaluating sleep patterns and quality, such as total sleep time, shallow/deep sleep time, and number of awakenings. Physical activity was the next most common measurement (35 cases), with activity duration and quantity of activity being measured. Gait measurements (number of steps, walking speed, etc.) and vital signs (heart rate, respiratory rate, blood oxygen saturation, etc.) followed in 29 cases, and 26 cases, respectively. Others included cough frequency, blink activity, seizure frequency and intensity, and Parkinson's disease motor measurements.

Applications of wearable devices

In recent years, the measurement range of wearable devices has expanded to include a wide variety of biometric information, including motor indicators such as nocturnal scratching movements, cough frequency, motor slowing, involuntary movements, and tremor, which can be obtained continuously and in real time.

This has enabled the quantification of clinical events that were previously difficult to evaluate objectively, as well as comprehensive evaluation of pathological conditions through integrated analysis of multiple indicators, and the use of wearable devices has undergone a qualitative evolution.

In this section, we will shift our perspective from the quantitative analysis up to the previous section and introduce representative examples of wearable device utilization that have emerged since the previous report, based on the relevant literature.

3-1. Quantification of clinical events that have been difficult to evaluate objectively in the past

The establishment of technology to directly capture disease-specific events, which used to rely heavily on subjective patient assessment, as objective digital indicators is one of the most important developments in recent years.

Objective evaluation of cough by acoustic monitoring

In a Phase 3 study of Gefapixant, a drug for chronic cough, a portable digital acoustic recording device, VitaloJAKTM , manufactured by Vitalograph, UK, was used. Patients carried the device for 24 hours, and computer algorithms and analysts objectively calculated the "mean change in 24-hour cough frequency. This "mean change in cough frequency over 24 hours" was used as the primary efficacy endpoint, and proved that the drug significantly reduced cough frequency compared to ^{placebo3, 4)}.

Quantification of curettage behavior during sleep by accelerometer

In a Phase 3 study of the atopic dermatitis drug baricitinib, the wearable sensor GENEActiv, manufactured by Activinsights in the UK, was used. The device is a wrist-worn triaxial accelerometer that continuously records data on arm movements during sleep, and identifies and quantifies patterns specific to the scratching behavior using a dedicated algorithm. Digital endpoints such as duration and intensity of nocturnal scratching, percentage of sleep time, and time of awakening after falling asleep are then calculated and used to evaluate treatment ^efficacy5).

3-2. Comprehensive evaluation of pathological conditions through integrated analysis of multiple indicators

An approach to comprehensively evaluate more complex pathologies by simultaneously and continuously measuring several different indicators with a single device and integrating them for analysis is also becoming more practical.

Evaluation of Parkinson's disease symptoms by integration of multilateral motor indices

In the Phase 3 study of Foslevodopa/Foscarbidopa, a Parkinson's disease drug, the wearable device "Personal Kineti-Graph Ⓡ (PKG)" manufactured by Global Kinetics, Inc. PKG analyzes data obtained from an accelerometer worn on the wrist like a wristwatch, using an algorithm specialized for Parkinson's disease, and simultaneously quantifies multiple motor indicators such as slow movement (bradykinesia), involuntary movement (dyskinesia), and tremor, and continuously visualizes the on/off state of the drug effect. This allows objective data to demonstrate how the drug stably and comprehensively controls overall motor symptoms in daily life. On top of that, "changes in dyskinesia and bradykinesia scores (median and interquartile range) measured by PKG" has been adopted as one of the secondary ^{endpoints6, 7)}.

As the above examples show, the use of wearable devices in drug development is expanding its role beyond simply measuring activity levels to include specific symptoms such as the number of coughs and the evaluation of overall disease by combining multiple pieces of information, and is evolving into an extremely useful tool for proving the efficacy of drugs in a multifaceted and objective manner. It is evolving into an extremely useful tool for proving the efficacy of drugs objectively and from multiple perspectives.

Challenges in utilizing wearable devices in clinical trials

Wearable devices enable the collection of more objective data that is independent of the interpretation, memory, and judgment of study participants and patients (i.e., free from bias), and they allow the continuous and timely collection and visualization of data on biological responses (exercise, sleep, seizures, etc.) in daily life that are difficult to collect through medical examinations and tests, The data can be collected and visualized in a continuous and timely manner. Furthermore, real-time support for study participants and patients can be provided through mutual communication between wearable devices and medical institutions that can check seizures, medication administration status, etc.

However, there are challenges in utilizing such a wide variety of data in drug development. The main challenges are listed below.

(1) Accuracy and interpretation of data

In addition to the quality of the device itself, wearable devices are usually susceptible to the measurement environment, the way the user wears the device, the performance of the sensor, and the position at which the device is worn, and may contain noise and variability. Therefore, in addition to how to interpret the vast amount of diverse data and utilize it as clinically useful information, new issues must be addressed, including the establishment of reliable reference values.

2) Validity of standardization between evaluation indices and devices

It is necessary to verify whether the data and evaluation indicators collected by wearable devices appropriately reflect outcomes that are truly meaningful and valuable to patients. On the other hand, the diversification of wearable devices has led to a lack of standardization among devices, making it difficult to compare and integrate data obtained from different devices. This may affect the interpretation of outcomes and the generalization of results.

(iii) Privacy and data security concerns

Wearable devices handle personal health data, raising concerns about privacy and data security. In addition to proper management in accordance with laws and regulations, adequate measures must be taken to reduce the risk of data leakage and unauthorized use.

(iv) Participant compliance (adherence)

In tests that require the use of wearable devices, it is important that participants continue to wear their devices properly. If some participants refuse to wear the devices or remove them frequently, data collection may be incomplete. Furthermore, the operation itself may be a hurdle for older participants or those unfamiliar with digital devices.

(v) Regulatory and approval issues

When data obtained from wearable devices are used for regulatory approval, there are many areas where evaluation criteria and approval processes have not been clarified. Therefore, validation with conventional evaluation items is necessary, and appropriate positioning in clinical trials must be established.

Summary and Discussion

Wearable devices are being attempted to be utilized in diverse aspects of clinical trials and are showing new possibilities. These devices are fundamentally changing the way data is collected in medical research because they can collect physiological data such as heart rate, step count, blood pressure, and sleep status in real time. The ability to collect data in real time complements traditional assessment methods that rely on self-reports and periodic medical examinations, and allows for objective and continuous monitoring of the health status of study participants. The detailed data thus obtained will contribute to qualitative improvements in clinical research, such as more precise evaluation of treatment effects, early detection of side effects, and understanding of changes in patients' lifestyles.

The results of the survey on the use of wearable devices in clinical trials in this report showed that the use of wearable devices in Phase 2 and Phase 4 trials has increased, while the use of wearable devices in Phase 3 trials has not increased significantly since the previous report. The main purpose of Phase 3 studies is to finally verify the efficacy and safety of a drug and to obtain data that can be used as the basis for an application for approval, so the requirements for wearable devices to be used in these studies are more stringent. The requirements for data accuracy, reliability, scientific validity of evaluation items, and completeness of data in accordance with Good Clinical Practice (GCP), the standards for conducting clinical trials, may be major barriers to utilizing wearable devices in Phase 3 trials. The analysis also found that the Japanese clinical trial team was not aware of any such requirements.

In addition, this analysis showed no increase in the number of cases of wearable device utilization in Japanese clinical trials since the previous report. In relation to this point, a survey conducted by the Data Science Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association reported the following issues in ^{utilization8)}.

(i) Conformity issues with study design

There are no suitable tests for the utilization of wearable devices."

② Lack of responsiveness to technical/operational issues

Handling, analysis, and training for handling and analyzing huge amounts of data", "Consideration of monitoring frequency and methods for data being acquired", "Burden on subjects (charging, synchronization, resistance to wearing the device for a long time, etc.)", "No established evaluation index", "How to proceed with wearable device validation".

(iii) Lack of information on vendor/device selection and reliability concerns

Selection of appropriate devices and vendors", "Ensuring device reliability", "Dealing with different approval status of devices in each country in global trials".

Wearable device technology is evolving day by day, and through integration with advanced technologies such as AI, new evaluation indices and analysis methods will be realized, which are expected to further contribute to medical care through the advancement of clinical evaluation. However, if Japan fails to keep pace with global trends in the use of wearable devices, develop a regulatory environment that enables their use, and overcome challenges, it will risk being left behind in global clinical trials that utilize these innovative technologies.

Wearable devices have the potential to revolutionize the way data is collected in clinical trials. The promotion of digitization, including addressing the above issues, is urgently needed.

Acknowledgments: The authors would like to express their sincere gratitude to former Senior Researcher Yasuhiko Nakatsuka at The Office of Pharmaceutical Industry Research for his cooperation and advice in the preparation of this article.

Note: Part of the content of this paper has been reorganized based on the article "Utilization of Wearable Devices in Drug Development: Analysis of Trends through June 2025, " ⁹⁾ published in "Pharmaceutical Science," Vol. 86, No. 1 (January 2026).

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