Device Strategy For eCOA: BYOD Or Provisioned?

By Mark Maietta, President, YPrime

The COVID-19 pandemic created a watershed moment in the drug development industry, accelerating further exploration into the use of advanced digital technologies for decentralized, virtual, and patient-centric trials. Collecting clinical outcome assessment data electronically from patients is one tool that provides significant benefits by enhancing clinical trial efficiency, minimizing patient and site burden, and improving patient compliance. There are also significant complexities with planning and implementing an effective electronic clinical outcome assessment (eCOA) solution that delivers all the possible benefits and a sponsor’s device strategy plays a critical role in the success of a clinical study. Which device is better for collecting eCOA—a patient’s own device, known as bring your own device (BYOD), or a vendor provisioned device (PD)?

The short answer is, “It depends.” There are questions we can ask and answer that can help guide sponsors toward one strategy or another based on the protocol, patient needs, risks, and risk mitigation. By asking the right questions, and understanding and preparing for all the variables, a sponsor can successfully implement the modality that increases patient compliance while minimizing missing data and risks to data integrity throughout the life of a study, even a long-term study.