Paving the Way for Advanced Clinical Trials with Wearables
The Clinical Research Innovation Initiative (CRII) is a collaborative effort to advance scientific rigor and improve healthcare outcomes.
Led by Dr Ted Smith and partnerships with the UofL Custom Wireless and Electronics Laboratory and a national network of research partners, the CRII provides planning assistance to UofL clinical investigators, to help ensure devices and software selected support a pathway to competitive research funding and distinguished scholarship.
View our Utilizing Wearable Devices in Clinical Trials webinar play list on YouTube here.
Wearable Device Research: Approach & Planning Form
Submitting this form early helps navigate the research process from ideation through IRB approval. By identifying institutional pathways, it minimizes procurement delays and offers design guidance for both commercial-grade and custom-engineered solutions.
Utilization of Wearables in Clinical Trials
Wearables minimize clinic visits, often resulting in higher adherence rates (studies show 70-80% adherence).
Approximately 2.2% of clinical trials in high-income countries have incorporated wearables since the start of 2020.
The global market for healthcare wearables was valued at US $33.85 billion in 2023 and is projected to reach US $250 billion by 2030. (NIH, Feb 2025)
Benefits and Challenges
Continuous, Objective Data Collection: Wearables provide real-time, continuous streams of objective data on health metrics like heart rate, activity levels, sleep patterns, glucose levels, and oxygen saturation. This minimizes patient recall bias and offers a more comprehensive picture of health than sporadic measurements. (Quanticate, Feb 2025; ACRP, Oct 2024; Crucial Data Solutions)
Enhanced Data Volume and Quality: By capturing data over prolonged periods in natural settings, wearables yield larger and denser datasets, leading to a deeper understanding of disease variability and treatment effectiveness. (Applied Clinical Trials Online, Nov 2023; PMC, July 2018)
Improved Patient Engagement and Adherence: Wearables reduce participant burden by minimizing clinic visits, often resulting in higher adherence rates (studies show 70-80% adherence). Patients feel more invested and are more likely to stay engaged. (Quanticate, Feb 2025; ACRP, Oct 2024)
Increased Efficiency and Cost Savings: Remote monitoring reduces manual data entry and errors, streamlines data integration, and can lead to faster decision-making. It also reduces travel time and costs for patients and investigators. (Quanticate, Feb 2025; ByMason, Oct 2023)
Novel Endpoints and Predictive Insights: Wearables allow for the creation of novel endpoints that can provide more sensitive measures of disease activity. When combined with AI/ML, wearable data can enable advanced analytics for pattern recognition, risk prediction, and early warnings about adverse events. (PMC, July 2018; Quanticate, Feb 2025)
- Wider Patient Recruitment: By enabling remote participation, wearables help recruit a broader and more representative patient pool, improving the generalizability of study results. (Crucial Data Solutions)
Data Management and Analysis: Wearables generate substantial amounts of raw data, posing challenges for data processing, validation, analysis, and integration into existing clinical systems. This requires customized approaches and robust infrastructure. (MaxisIT; Clinical Research News Online, Mar 2024)
Device Selection and Validation: Choosing the right wearable device that aligns with trial objectives is crucial. There's variability in design, data collection methods, and regulatory approval status. Many consumer wearables are not certified medical devices, impacting their use for clinical purposes. (MaxisIT; Global Pharma Tek, May 2024)
Data Quality and Interoperability: Ensuring consistent data quality across different devices and sensors, and achieving interoperability between various wearable platforms and clinical trial systems, remains a significant hurdle. (PMC, Feb 2023)
Logistical Challenges: Managing device inventory, timing wear periods, and retrieving devices (especially in cases of screen failures) can be logistically complex. (Clinical Research News Online, Mar 2024)
Privacy and Security: Wearables collect highly sensitive health data, raising concerns about data ownership, privacy, and cybersecurity. Robust security measures and adherence to regulations like HIPAA are essential. (MaxisIT; Climedo, Mar 2022)
Patient Acceptance and Adherence: While generally improving adherence, factors like comfort, convenience, and digital literacy can still impact a participant's willingness to use and consistently wear the devices. (GAO, Jan 2025; MaxisIT)
- Cost: The deployment of wearables in clinical studies can be costly, depending on the device type, collection infrastructure, and participant numbers. (Global Pharma Tek, May 2024)
Get Involved
The CRII is more than just an initiative; it's a collaborative effort to advance scientific rigor and improve healthcare outcomes. We believe that by embracing these novel technologies responsibly and thoughtfully, we can unlock new possibilities in clinical research.
Do you have expertise in clinical trial technologies using wearables?
Are you interested in adopting wearables into your research?
We invite you to get involved!