Capturing Electronic Clinical Outcome Assessments (eCOAs): The Case for BYOD Trials

Clinical outcome assessments (COAs), which can be reported by patients, clinicians, caregivers or derived from standardized performance tasks, are increasingly being collected electronically, both at research sites and remotely.  

There are several ways data capture for electronic clinical outcome assessments can be implemented: 

• Provisioned devices: Devices supplied by the study sponsor, such as smartphones or tablets, with the app or web solution pre-installed, and the devices are locked down to only allow study-related activities  
• Bring Your Own Device (BYOD): Participants use their personal devices to complete assessments via apps or web portals. BYOD clinical trials can improve convenience, engagement and compliance. While this approach is often associated with remote data collection, it can also be implemented at study sites 
• Web-based platforms: Accessible from any internet-connected device, these platforms allow the completion of assessments at home or in clinic without dedicated hardware 
• Digital sensors and wearables: Devices track physical activity, gait or other physiological measures 

Why Consider Clinical BYOD for Healthcare? 

The advantages of BYOD align closely with patient centricity and operational efficiency: 

• Ease of participation: Participants can complete electronic clinical outcome assessments on familiar devices without needing to carry or maintain additional hardware 
• Cost-effective and resource-efficient: Fewer devices to purchase, maintain or ship reduces operational costs 
• Global smartphone usage: The majority of participants have access to personal devices suitable for eCOA collection 
• Increased engagement and compliance: Familiarity with personal devices can improve adherence to study protocols, reduce missing data and enhance participant retention 
• Preferred by participants: Research suggests individuals often prefer using their own devices rather than learning to use provisioned devices 

Key Considerations for BYOD Clinical Trials  

When migrating COAs from paper to electronic formats, it’s essential to maintain measurement properties to ensure results remain comparable. With BYOD, multiple electronic formats and device types introduce “mixed modes” of administration, which can complicate this process.  

There can be hesitancy from some sponsors, due to: 

• Concerns about data quality, integrity and variability ​ 
• Regulatory acceptance uncertainties ​ 
• Lack of formal guidance around BYOD from regulators

However, there is an abundance of evidence supporting a BYOD approach for eCOA collection: 

• Paper vs. BYOD vs. provisioned devices: Very high correlations exist between these modes for common response scales (VRS, NRS, VAS); (O’Donohoe et al., 2023) 
• Visual Analog Scales (VAS): A review of 19 studies with lengths ranging from 2.1 cm to 28.9 cm concluded that paper VAS and electronic VAS are comparable; (Byrom et al. 2022) 
• Scrolling vs. non-scrolling: Measurement properties are preserved regardless of scrolling on handheld devices; (Shahraz et al. 2021)