PMU61 State of BYOD: Lessons in Acceptability and Compliance from 35 Trials

Abstract

Interest in bring-your-own-device (“BYOD”) studies has risen rapidly since the start of the global COVID pandemic. To better inform our understanding of patient acceptability and compliance in BYOD, we completed a retrospective review of clinical trial operational data. Operational data was analyzed from 35 clinical trials from 2017 to the present in the US and EU collecting eCOA data using BYOD; some trials also provisioned handheld devices for participants who chose not to use BYOD. Key outcomes of interest were: % of patients requesting provisioned device and compliance rates. Sub-group analysis was conducted by phase and therapeutic area, sample size permitting. The 35 trials included pivotal phase II/III and phase IV/observational/long-term safety studies. The most-represented therapeutic areas were CNS (20%), hematology (11%), dermatology (11%), pulmonology (9%), women’s health (9%), and virology (9%). Combined, they included 1,817 sites and 60,547 participants. 15 trials (43%) did not offer provisioned devices to participants (i.e., 100% BYOD). Of the 20 trials (57%) that offered provisioned devices to participants, device provisioning rates ranged from 10%-75% (median 20%). Overall compliance for patient-completed assessments ranged from 89% to 92%. Trials that were 100% BYOD had an average compliance of 89% and trials that offered provisioned devices had an average compliance of 92%. BYOD is increasingly recognized as a feasible and practical methodology for collecting eCOA data in clinical trials, especially in indications that require frequent and/or acute data collection from the subject, such as headache/migraine and bleeding disorders. With broad access to mobile phones/other devices, it is not surprising that we found minimal differences in subject compliance with diary completion between studies that did and did not offer a provisioned device, however, this should be explored further to discern any potential differences based on patient characteristics and/or reporting frequency.