Considerations for Conducting Bring Your Own "Device" (BYOD) Clinical Studies

Area of Science:

• Digital Health
• Clinical Research Technology
• Data Acquisition

Background:

• Digital health technologies offer novel data collection methods for clinical research, moving beyond in-clinic snapshots.
• Multi-modal sensors in digital health tools derive comprehensive, clinically meaningful endpoints from real-world data.
• Clinical trials can utilize provisioned devices or a Bring Your Own Device (BYOD) model for data generation.

Purpose of the Study:

• To provide considerations for designing and deploying Bring Your Own Device (BYOD) models in clinical research.
• To address challenges related to user-friendliness, participant compliance, and reduced bias associated with BYOD.
• To offer insights for academic researchers, drug developers, and patient advocacy organizations on implementing BYOD studies.

Main Methods:

• The study outlines key considerations for BYOD implementation in clinical research.
• Considerations include stakeholder engagement, study design (informed consent, recruitment), and technology selection.
• Data management, compliance, monitoring, and statistical approaches are also detailed.

Main Results:

• BYOD models can enhance participant experience and compliance by using familiar technologies.
• Significant technical, operational, regulatory, and ethical challenges exist, including data heterogeneity and equitable recruitment.
• Successful BYOD implementation requires strategic planning across multiple study domains.

Conclusions:

• BYOD presents a promising yet complex approach to clinical research data collection.
• Addressing identified challenges through careful planning is crucial for successful BYOD clinical studies.
• This primer offers essential insights for researchers and developers navigating BYOD implementation.