Monitoring hypertension or blood pressure with a smartwatch mobile device
Collecting accurate, reliable data in clinical trials once meant trial visits. Patients diligently taking the medication or intervention would trek to the nearest trial center to undergo a battery of tests before being shuttled home. But as decentralized clinical trials (DCTs) sweep through clinical and pharmaceutical research, there’s a new data collection method in town: health wearables.
Pioneered initially by the fitness industry, health wearables allow trial participants to be continuously monitored without leaving the comfort of home. Less burdensome, less costly, and less prone to human error, these medical wearables are what’s powering the DCT revolution.
Little wonder management consulting firm Kaiser Associated predicted in 2018 that by 2025, 70% of trials would incorporate some form of wearable or fitness tracker1 – and that was before the pandemic.
What are Wearables in Healthcare?
‘Health wearables,’ ‘medical wearables,’ or just ‘wearables’ are electronic devices that collect a person’s vital signs. Using the cloud, they log this information into a central database. For consumer wearables and fitness trackers, individuals can access the data via the brand’s online portal.
However, in clinical trials, there remains a significant lack of a simple, efficient, and easy-to-use platform to track data from multiple healthcare wearables (something CDConnect fixes).
As of 2023, 44% of Americans own wearable health tracking devices, such as smartwatches or smart rings, monitoring health metrics ranging from sleep patterns to heartbeat fluctuations, according to the Rock Health Digital Health Consumer Adoption Survey.
Meanwhile, the global wearable technology market continues to expand, with projections indicating significant growth in the coming years.
Benefits of Using Wearables
Beyond their specific applications in clinical trial transformation initiatives, wearables offer a range of broader advantages that enhance trial efficiency and participant experience. From improving data quality to increasing accessibility, these benefits are transforming medical research.
Improved Participant Recruitment and Retention:
Reducing the need for frequent travel makes trial participation more accessible and less burdensome for participants. This convenience encourages higher enrollment and retention rates, particularly for individuals with mobility challenges, household responsibilities, or those living far from a trial site.
More Reliable and Continuous Data Collection
Wearables enable remote data monitoring of participants, capturing information more frequently than traditional trial visits. Since these devices collect information passively, they minimize recall bias and accurately represent a participant’s physiological state in their daily life and natural environment..
Greater Convenience and Engagement for Patients
Allowing participants to contribute data from home reduces disruptions to their daily routines, making trials more patient-friendly. A seamless experience encourages adherence to study protocols, which leads to more comprehensive and reliable safety data.
Reduction in Trial Costs and Timelines
Automating data collection through wearable technology decreases the need for in-person monitoring, ultimately reducing expenses associated with on-site visits. The ability to detect adverse events early and make quicker data-driven decisions can also accelerate drug development timelines.
Broader Inclusion of Underrepresented Groups
By removing physical and geographical barriers, wearable technology makes clinical study participation more inclusive. Remote participation expands access to research for individuals from rural areas, racial and ethnic minority groups, and those with disabilities, leading to more diverse and representative study results.
9 Ways Health Wearables Are Transforming Decentralized Clinical Trials
Not sure how a medical wearable could boost your DCT? The possibilities are endless. Here are a few options currently being considered or explored:
1. Remote Patient Engagement
Send reminders to patients about taking medications, completing surveys, or performing specific tasks related to the trial. Consistent engagement and tracking improve adherence and support the handling of data in clinical research, ensuring accurate and timely patient-reported outcomes.
2. Adverse Event Detection
See blood pressure spiking on the blood pressure watch? Notice a sudden drop in blood glucose? Detecting adverse events is a core aspect of clinical trials (aka pharmacovigilance). Through integrated algorithms and continuous data collection, wearables can help identify unusual patterns or data anomalies indicative of potential adverse events. Clinical trials have never been safer!
3. Patient Feedback Collection
It is not a feature of all health wearables, but some allow patients to input data or feedback manually. This could include:
- Mood ratings
- Pain levels
- Perception of sleep quality
- Qualitative notes about an experience
4. Identify At-Risk Patients
Certain constellations of symptoms point toward an impending medical event – be it a heart attack, diabetic ketoacidosis, fall, etc. Doctors and researchers evaluating the real-time data can spot these signs (augmented by advanced algorithms) and contact a participant to see how they’re feeling.
Such participants can then receive higher-level treatment and observations to safeguard their health.
5. Geolocation and Environmental Data
Wearables equipped with GPS can record a patient’s location. Combined with environmental data, this information is extremely useful in trials studying environmental exposures or activity patterns in specific geographical settings.
For example, an analysis of asthmatics could combine the participant data collection with regional air quality levels.
6. Real-world Movement Analysis
Beyond just counting steps, advanced wearables analyze a participant’s gait posture or even detect falls – critical for trials related to neurodegenerative conditions, orthopedics, or geriatric populations.
7. Perform Long-Term Sleep Studies
Sleep studies aren’t always reliable. Usually conducted in hospitals, they suffer from a critical flaw – half your brain stands guard when sleeping in a new location.
Accelerometers, heart rate sensors, and other wearables allow researchers to monitor sleep stages, duration, and disruptions from the comfort of the participant’s home.
8. Adherence and Dropout Rates
By monitoring wear time, researchers can assess how consistently participants use the wearables and potentially anticipate and mitigate reasons for dropouts.
9. Behavioral Patterns
Wearables can monitor walking, running, and sedentary activities. Some even monitor and analyze patterns like screen time, social interactions, and daily routines relevant to mental health studies or lifestyle interventions.
Challenges in Using Wearables in Decentralized Clinical Trials
Despite the growing adoption of wearables in clinical research, their integration into decentralized clinical trials presents unique challenges. From concerns over patient safety to technological barriers, these hurdles must be carefully addressed to ensure the reliability and inclusivity of wearable devices in clinical studies.
- Investigator Oversight and Patient Safety: Limited face-to-face interactions in decentralized clinical investigations can make it difficult for investigators to monitor participants effectively. Reduced physical examinations may lead to concerns about patient safety and proper medical oversight.
- Secure Data Storage and Management: With electronic data being collected remotely, ensuring secure storage and proper data handling is crucial. Strong data management platforms are necessary to handle multiple data sources effectively and maintain compliance with regulatory standards.
- Safe Transport of Treatments: Some experimental treatments require special handling, such as refrigeration during transport. Ensuring safe and timely delivery to participants’ homes is a logistical challenge that must be addressed in DCTs.
- Technology Usability and Training: Both clinical research staff and participants must learn how to use monitoring devices correctly. Participants may also need guidance on self-administering treatments or reporting adverse events accurately from home.
- Digital and Technological Barriers: Not all participants are comfortable with telemedicine solutions or have access to the necessary technology. This digital divide could lead to a younger, more tech-savvy target population that does not fully represent the broader patient demographic.
Best Practices in the Implementation of Wearables
While the benefits of wearables in decentralized trial activities are substantial, their successful implementation requires careful planning. Adopting best practices ensures that these technologies are used effectively, maximizing their potential while addressing reported challenges.
- Develop a Long-Term Data Strategy: Instead of treating wearable data collection as a short-term experiment, establish a clear, strategic plan for integrating wearables into clinical investigations. A well-structured evidence-generation approach ensures meaningful insights and regulatory acceptance.
- Ensure Platform Stability and Compliance: Given the fast-paced evolution of technology, maintaining data quality over the years is crucial. Choose digital health tools that prioritize stability and backward compatibility over frequent updates to prevent disruptions during trials.
- Retain Original Data for Future Insights: Wearable devices generate vast amounts of raw sensor data, which serves as a valuable resource for ongoing and future research. Keeping raw data intact allows for evolving outcome measures and compliance with regulatory standards.
- Adopt Tailored Statistical Methods: Wearable data differs from traditional trial endpoints, requiring specialized analytical approaches. Allocating resources to biostatistical expertise and collaborating with stakeholders can maximize the potential of digital health technologies in trial elements.
- Engage in Cross-Industry Collaboration: Partnering with industry stakeholders can accelerate the validation of digital clinical metrics and refine wearable-based trial methodologies. Respondents indicated that pre-competitive working groups help address regulatory and operational challenges collectively, streamlining the implementation of DCTs.
Closing Thoughts
Health wearables and fitness trackers have transformed decentralized trials in clinical research through continuous data collection in real-world settings. Not only do these devices enhance the depth and breadth of patient data, but they also improve trial accessibility and patient engagement.
As the wearable market expands, its role in reshaping clinical research methodologies will continue revolutionizing the sector. The only missing piece of the puzzle is a one-stop centralized database to collect, analyze, and store wearable data from multiple participants and devices.
If you are looking for a smarter way to manage data in decentralized clinical trials, CDConnect™ is the solution. Our easy-to-use platform captures real-time insights, ensures data security, and seamlessly integrates with various devices, making clinical research more efficient and reliable.
FAQs for Wearables in Decentralized Clinical Trials
How Do Wearables Ensure Data Security and Privacy in Decentralized Clinical Trials?
Wearables collect sensitive health information. Therefore, strong encryption, secure data transmission, and compliance with regulations like HIPAA and GDPR are crucial. Trial sponsors must implement robust cybersecurity measures to protect participant data.
Can All Clinical Trials Incorporate Wearable Technology?
While many trials can benefit from wearables, their suitability depends on study objectives, patient demographics, and regulatory considerations. Trials requiring complex lab tests or in-person interventions may still need traditional trial models.
What Types of Health Data Can Wearables Collect in Clinical Research?
Wearable devices can capture a wide range of physiological and behavioral health metrics. Depending on the device, these may include heart rate, blood oxygen saturation (SpO₂), physical activity, sleep patterns, blood pressure, glucose levels, and electrocardiogram (ECG) readings. This continuous, real-world data offers valuable insights into participants’ health status outside traditional clinical settings.
Are Wearable Devices in Clinical Trials Regulated by Health Authorities?
Yes, regulatory agencies like the FDA and EMA provide guidelines for using digital health technologies in clinical research. These guidelines ensure data integrity, patient safety, and the clinical validation of wearable-based endpoints.
