Patient Diaries Done Right: A Blueprint For Success

By Juliane Mills, MS, MPH Senior Director, Therapeutic Strategy Lead, Rare Disease ; Rolana Avrumson, MS Vice President of Clinical Projects, Clinical Assessment Technologies ; Nathan Chadwick Senior Director, Therapeutic Strategy Lead, Rare Disease

In this paper experts explore the critical role of patient-reported outcome (PRO) data collection through diaries in clinical trials, emphasizing the transition from traditional paper diaries to electronic diaries (eDiaries). eDiaries are favored for their reliability, accuracy, and ability to provide real-time data, which enhances patient compliance and reduces site burden. Despite higher initial costs, eDiaries improve data quality and management, offering significant advantages over paper diaries. Important factors to consider when selecting a diary platform include your therapeutic focus and complexity, and the ability to customize diaries based on patient and caregiver experiences to avoid a one-size-fits-all approach.

Regulatory guidance and quality assurance processes ensure technical requirements are met, and early diary development is crucial for regulatory approvals and effective training. A dedicated Clinical Assessment Technologies team ensures optimal diary development, tailored to study needs, enhancing the quality and reliability of clinical trial outcomes. This paper highlights challenges such as data variability, adherence, and cultural adaptations, recommending Cognitive Debriefing Usability Testing (CDUT) and linguistic validations to ensure validity and cultural appropriateness. The choice between dedicated devices and a bring-your-own-device (BYOD) approach for eDiaries is discussed, with considerations for study population and data security. Despite potential future shifts towards wearable technology, diaries remain essential for reliable and valid data collection in clinical trials.