Clinical trials are invaluable in the development of effective and safe medical technology, pharmaceuticals, and medical treatments. In order to gain valuable insights into the efficacy and safety of these items, data collection and analysis must be done as accurately as possible.
Integrating wearable sensor technology and advanced software solutions into clinical trials is one of the best ways to ensure data accuracy. But the benefits of utilizing wearables in this realm go far beyond that.
The integration of wearable sensors and software solutions can significantly enhance clinical trials. Below, we look at the current role of wearables in study trials, their benefits and challenges, and explore the future of this niche, including opportunities for innovative MedTech companies in the world of clinical trial wearable sensor development.
The Role of Wearable Sensors in Clinical Trials
Wearable sensors are integrated wearable devices or patches that collect data from the user and transfer it to a digital platform to be interpreted by the user or medical professionals. In the case of wearables used in clinical trials, the data is often unavailable to the user and only seen by the researchers involved in the study.
What form these wearable devices take depends on the needs outlined by the research. In any form, wearables have a long list of benefits when used in clinical trials. As with all technology, they also come with their share of challenges. Despite these, there are many instances today of wearable devices being successfully used in clinical trials of all kinds.
Types of Wearable Sensors
In the medical technology field, there are various types of wearable sensors used for monitoring and collecting physiological data. Many of these types have applications within clinical trials.
These are some of the most common types of wearable sensors currently in production:
- Biosensors – Biosensors detect and measure biological information, such as heart rate, blood pressure, temperature, respiratory rate, and electrocardiogram signals. These sensors can be integrated into wearable devices like smartwatches, wristbands, or patches.
- Accelerometers – These measure acceleration, movement, and posture. They are often used to track physical activity, analyze gait, and assess balance. Accelerometers can be found in fitness trackers, activity monitors, and smart clothing.
- Gyroscopes – Gyroscopes measure angular velocity and orientation. They are commonly used in wearables to monitor body movements, posture, and balance. Gyroscopes are particularly valuable in applications related to rehabilitation and sports performance.
- Optical Sensors – These sensors use light to measure physiological parameters such as blood oxygen saturation, blood glucose levels, and skin perfusion. They are often integrated into wearable devices like smartwatches or finger clips to provide non-invasive measurements.
- Electrodermal Activity Sensors – EDA sensors measure changes in skin conductance, which can reflect emotional and physiological arousal. These sensors are used to monitor stress levels, emotional responses, and autonomic nervous system activity.
- Electromyography Sensors – EMG sensors detect and record electrical activity produced by skeletal muscles. They are used to assess muscle function, detect muscle abnormalities, and assist in rehabilitation.
- Temperature Sensors – These measure body temperature variations. They are utilized for monitoring fever, thermoregulation, and assessing skin temperature. Temperature sensors can be integrated into wearable patches, bands, or smart clothing.
- Strain Gauges – Strain gauges measure changes in mechanical strain or deformation. They are commonly used in wearable devices for tracking muscle movements, joint angles, and biomechanical parameters. Strain gauges are often found in sports performance monitoring systems and rehabilitation devices.
- Blood Pressure Sensors – These are used to measure arterial blood pressure. These sensors can be incorporated into wearable cuffs or patches to enable continuous blood pressure monitoring throughout the day.
- Environmental Sensors – Environmental sensors measure factors in the external environment that may impact health, such as air quality, UV radiation, or humidity. These sensors are integrated into wearable devices to provide contextual information for health monitoring.
In the past, these types of sensors were commonly housed alone in their own wearable devices. Today, it is far more common to find wearables that include multiple sensors to measure a range of parameters and provide multiple data streams to connected devices and platforms.
Benefits of Using Wearables in Clinical Trials
Just as wearable devices have provided a range of benefits to consumers, doctors, and people living with chronic conditions, they have also benefited researchers conducting clinical trials. Some of their benefits are well known while others are just being realized.
Real-Time Monitoring of Patient Data
Wearable sensors enable continuous and real-time monitoring of patients, providing a more comprehensive understanding of a participant’s health status throughout the duration of the clinical trial. Wearables also enable researchers to capture real-world data, offering insights into patients’ daily activities, behaviors, and responses to interventions.
Increased Accuracy and Reliability of Data
The use of wearable sensors in clinical trials enhances data collection by reducing reliance on self-reporting and minimizing recall bias. This leads to more accurate data and more robust research findings.
Improved Patient Compliance and Engagement.
Wearable tech enhances patient engagement and compliance by providing personalized feedback, reminders, and incentives, leading to improved participant retention rates and data quality. They can also help identify subtle changes in patient health parameters, allowing for early detection of adverse events or treatment efficacy and enabling timely interventions. These factors help reduce risks associated with clinical trial participation.
Additionally, the use of software solutions in clinical trial management streamlines processes such as patient recruitment, enrollment, and data collection to get trials started sooner while also producing faster results.
Remote Monitoring Capabilities
The remote monitoring capabilities offered by wearables allow researchers to monitor patients’ health remotely, reducing the need for frequent hospital visits. Not only does this make clinical trials more convenient for patients, but it reduces the burden on healthcare and research facilities.
Produce Faster Results
Integrating wearable sensor data with software solutions improves data management, analysis, and visualization. It also facilitates the identification of patterns, trends, and insights from the collected data.
The integration of wearable devices with mobile apps and cloud-based platforms enables seamless data collection, storage, and analysis, facilitating efficient clinical trial management. The integration of wearable technology in clinical trials can accelerate drug, device, and treatment development processes by providing objective and real-time data on safety and efficacy much more quickly.
Challenges of Integrating Wearables in Clinical Trials
While the benefits of integrating wearable technology into clinical trials are numerous, there are also some challenges researchers face when utilizing this technology. It is important to understand these challenges and how to mitigate them when developing wearable technology and connected software for use in clinical trials.
Data Security and Privacy Concerns
Wearable devices generate a significant amount of sensitive patient data, including personal health information. Ensuring the security and privacy of this data is paramount to maintaining participant trust and complying with regulations such as HIPAA. Implementing robust data encryption, access controls, and secure data storage systems are essential to mitigate security and privacy concerns.
Compatibility and Interoperability
There is a wide range of wearable devices available, each with its own specifications, data formats, and connectivity options. Integrating data from diverse wearable devices into a cohesive system can be challenging.
Compatibility issues can arise when attempting to aggregate data from different devices or when integrating wearables with existing clinical trial management or electronic health record (EHR) systems. Developing standardized protocols, data formats, and communication interfaces can help address these compatibility challenges.
Regulatory Compliance Considerations
Clinical trials involving wearables must adhere to regulatory guidelines and ensure compliance with ethical standards. The use of wearables may require obtaining additional approvals from regulatory authorities, such as the FDA. Compliance with regulations pertaining to data protection, patient consent, and adverse event reporting is crucial.
Data Quality and Reliability
While wearables reduce reliance on self-reporting and minimize recall bias to provide more accurate data, there is still a potential for error. Ensuring the accuracy, reliability, and validity of the collected data is necessary but can be challenging.
Factors such as sensor accuracy, calibration, and variability among individuals can impact data quality. Standardizing data collection protocols, validating the accuracy of wearable sensors, and conducting rigorous data quality checks are essential to address these challenges.
Participant Engagement and Compliance
While wearables have many advantages in increasing participant engagement and compliance, they can also pose some challenges in this area. Factors such as device usability, comfort, and participant motivation can impact adherence.
Designing user-friendly wearables, providing clear instructions, and implementing strategies to enhance participant motivation and engagement can help mitigate these challenges.
Data Management and Analysis
Wearables generate a vast amount of data, which can pose challenges in terms of data storage, management, and analysis. Ensuring efficient data management systems, data integration capabilities, and scalable infrastructure to handle the volume of data collected is crucial. Additionally, implementing advanced analytics and machine learning algorithms to extract meaningful insights from wearable data can require specialized expertise and resources.
By 2025, it’s predicted that 70% of clinical trials will incorporate wearable sensor technology(1). Considering that number was at just 10% two years ago, this represents an incredible amount of growth.
Already, we have seen numerous success stories from researchers who have taken advantage of the many benefits of integrating wearable technology into their clinical research and trials. Here are a few of those success stories to give you an idea of the potential applications of wearables in this market:
- Pfizer utilized a wrist-worn accelerometer sensor in an eczema treatment trial to measure participant scratching rates and patterns during sleep.
- Johnson & Johnson launched a virtual study to determine the new Apple smartwatch’s ability to reduce stroke risk by sensing atrial fibrillation.
- Long before wearables were being used widely across clinical trials, continuous glucose monitors were vital to studies involving diabetes. Today, these quickly advancing wearables are used in many types of research inside and outside of diabetes.
- ResearchKit, which was launched by Apple, is open-source software that provides a framework for researchers to create their own apps for collecting clinical data from wearable devices. This software has already been utilized by dozens of researchers in clinical trials.
- The Memorial Sloan Kettering Cancer Center recently teamed up with a cloud-based analytics company to assess the quality of life of myeloma patients using wearable sensors to track their activity and sleep patterns.
The Future of Wearables in Clinical Trials
There are clear advantages to utilizing wearable devices and connected software in clinical trials. As technology advances and more researchers, regulatory bodies, and healthcare providers embrace their use, these advantages will only grow.
Already, we are seeing advancements and notable trends in wearable technology for the clinical research field. But many opportunities for growth and innovation remain.
Emerging Trends and Advancements
Historically, wearable devices were limited to the kind patients wore on their bodies or that were implanted in the body. Watches, smart clothing, and patches are all common iterations of this idea. More recently, developers have extended the definition of wearables to include ingestible devices.
Back in 2017, the FDA approved the first pill that contained a smart sensor to track ingestion. The sensor was paired with aripiprazole, a drug used to treat schizophrenia, bipolar disorder, and depression. Similar sensors could be vital in helping track dose compliance in clinical trials for drugs of all types to help increase the accuracy of the data collected.
Another trend that is becoming commonplace in clinical trial wearable usage is the integration of Big Data, IoT, AI, and machine learning to help process and analyze the vast amount of data produced by wearable sensors.
Leveraging AI and machine learning algorithms, especially, can unlock the potential of wearable sensor data. Recent advancements in this field have led to advanced data analytics, pattern recognition, and predictive modeling, enhancing the interpretation and utilization of wearable sensor data in clinical trials.
Opportunities for Innovation in the Medical Technology Industry
As the use of wearables and connected applications in clinical trials becomes more commonplace, the opportunities for development in this area will only grow. Currently, there are several opportunities for innovation that medical technology and software companies can capitalize on. These opportunities include:
- Advanced Sensor Technology – Developing and improving the accuracy, sensitivity, and reliability of wearable sensors is an ongoing opportunity. Innovations in sensor technology can enhance the collection of physiological data, enabling more precise monitoring of various health parameters during clinical trials.
- Miniaturization and Form Factor – Creating smaller, more discreet wearable devices can improve patient comfort and compliance. Innovations that focus on miniaturization and enhancing the form factor of wearable sensors can make them less intrusive and more convenient for patients to wear, thereby increasing acceptance and engagement in clinical trials.
- Multi-Modal Sensors – Integrating multiple sensors into a single wearable device can provide a comprehensive and holistic view of a patient’s health status. Medical technology companies can explore the integration of different sensor modalities, such as combining physiological sensors with environmental sensors or incorporating imaging capabilities, to capture a broader range of data for clinical trials.
- Long-Term Wearables – Developing wearable devices that can be comfortably worn for extended periods is a largely missed opportunity in this niche. Long-term wearables enable continuous monitoring over extended durations, allowing researchers to gather more comprehensive and reliable data throughout the entire clinical trial process.
- Data Integration and Interoperability – Innovations that focus on seamless data integration and interoperability can facilitate the integration of wearable sensor data with other clinical trial management systems, EHRs, or data analytics platforms. This enables efficient data management, analysis, and visualization, providing researchers with actionable insights.
By focusing on these opportunities for innovation, MedTech companies can further advance the capabilities and applications of wearable sensors in clinical trials. This will lead to improved patient outcomes, streamlined research processes, and enhanced data-driven decision-making in healthcare.
A Bright Future for Wearable Technology
The integration of wearable sensors and software solutions has the potential to revolutionize clinical trials, leading to more efficient, patient-centric, and evidence-based healthcare practices.
Researchers are already beginning to see the numerous benefits of integrating this technology into their clinical studies. As wearable tech and its connected software continue to advance, we will only see the opportunities for product development in this market grow.