Reflections on the Optimal Use of eDiaries for Data Collection in Vaccine Clinical Trials (Preprint)

UNSTRUCTURED Recent years have witnessed a transformative shift in the way patient-reported outcomes are captured. The increasing adoption of digital health technologies offers exciting possibilities for more efficient, engaging, and insightful electronic data collection. Electronic diaries (eDiaries) represent a paramount resource that could improve data quality, reduce costs, and limit the burden on clinical staff and trial participants. Herein, we present our perspective on how to effectively use eDiaries to optimize the data collection processes in vaccine clinical trials. We begin with with a brief description of the benefits of eDiaries in vaccine clinical trials and provide reflections on key measures such as programming the eDiary platform, training the trial staff and participants, and real-time monitoring of participant compliance, which are crucial for leveraging eDiaries for optimal data collection. By implementing the measures discussed in this paper, eDiaries can offer significant advantages for both trial participants and clinical investigators by ensuring quality and integrity of the data collected.