Compliance and Design Features of Electronic Participant-Reported Dosing Diaries

OBJECTIVES: The extent to which participants adhere to prescribed dosing regimens is a critical factor in clinical trials and a regulatory priority. Participant-reported dosing using electronic diaries (eDiaries) is valuable in evaluating drug adherence by providing near-real time data for site monitoring and intervention. We examined electronic dosing diary completion across studies and described design features that can impact data integrity.

METHODS: Data from 16 studies across phases and multiple therapeutic areas were analyzed for content and compliance with dosing eDiaries using Clario’s app.

RESULTS: Few studies included instructional screens on how to complete the diary (6%) or dosing instructions (25%). Dose timing was collected in most (81%) diaries. A question to confirm if a dose was missed was included in about half (44%) of the diaries. Compliance was examined for studies with once- or twice-per-day dosing diaries (n=9). Compliance was similar for 1x/day (88%, n=5 studies) and 2x/day (89%, n=4 studies) dosing diaries. Compliance remained high over time, with 88% of diaries completed at 12 weeks for both 1x and 2x/day diaries. All diaries were programmed with reminder alarms, emails to sites when 1 or 2 consecutive diaries were missed, and an on-demand compliance report.

CONCLUSIONS: The varied content of these dosing diaries suggests there is a need for more consistency and standardization of requirements to support data quality. The high compliance across studies and over time suggests that eDiaries are a feasible approach for assessing drug adherence in clinical trials. More work is needed to determine whether compliance with an eDiary is a useful proxy for, and the features that contribute to, dosing adherence. As we continue to advance in the development of therapies, optimizing participant-reported dosing using eDiaries will remain a critical component in testing drug efficacy and safety.