By Gena Gough; Co-Authors: Kim Romanello and Kyle Hogan
The biggest challenge facing clinical research today is the need to gather, analyze, and report data. To collect patient data more efficiently, the industry has turned to electronic patient-reported outcome (ePRO) tools, which allow patients to enter data themselves, most often on devices provided to them. With more than three-quarters of Americans owning smartphones, it is only natural that researchers are increasingly exploring bring-your-own-device (BYOD) strategies for their trials; that is, allowing patients to utilize their own devices to collect data within the context of a clinical trial.
The idea of BYOD for use in clinical trials during any phase has historically been conceptualized as a futuristic alternative, rather than what it actually is — a viable option for many clinical trials. While there has typically been hesitance among sponsors and CROs to choose a BYOD model for their study, there is an increasing number of trials that have successfully deployed this model with great results. Many of the common concerns about BYOD are exacerbated by the lack of guidance on what is acceptable, as there is no official declaration by the FDA, either in favor of or against. Clinical Ink has experience with BYOD in all phases of trials, including Phase III, and their eClinical Solutions team is well-versed in the analysis that should be done before deciding whether BYOD is an option for your study.