PRM174 - OPERATING SYSTEM UPGADES DO NOT ADVERSELY AFFECT ECOA COMPLETION BEHAVIOR WHEN USING A BRING YOUR OWN DEVICE (BYOD) APP.

Abstract

To understand the effect of operating system upgrades managed by subjects when using their own device (Bring-your-own-device – BYOD) to collect eCOA data on ongoing eCOA data completion rates, based on device usage data collected in a large ongoing clinical trial. eCOA completion compliance and access-log data were explored to understand the impact of operating system upgrades on eCOA app use and diary completion, for subjects participating in a large ongoing clinical trial (n=10,000+, ages 50 to 85+, 20+ countries). The clinical trial collected eCOA data using a BYOD app solution, with provisioned handsets for subjects unable/unwilling to use BYOD. eCOA compliance was 83.0% (BYOD: 85%, Provisioned: 82%). BYOD was used by 2,500+ patients in the study, 48% and 52% of using the iOS and Android apps respectively. During the active phase of the study, 49% of subjects completed one or more operating system upgrades. Some subjects using iOS devices completed up to 14 minor/major operating system upgrades during the study. The eCOA compliance rate amongst subjects completing operating system upgrades was 86% compared to 83% for BYOD subjects not completing operating system upgrades on their handsets. The current study appears to show that operating system upgrades have no effect on eCOA completion compliance when using BYOD. While the lack of control over operating system upgrades has been suggested to be a potential barrier to BYOD use and eCOA app compatibility, the performance data form this study suggests that this aspect is unlikely to limit the application of BYOD in future clinical trials.