Published in npj Digital Medicine in December 2025, “Best Practice Recommendations and Considerations for Designing and Electronically Implementing Event-Driven Diaries in Clinical Trials,” is a landmark publication developed through a collaboration between Critical Path Institute’s Electronic Clinical Outcome Assessment Consortium, the Patient-Centered Evidence Consortium and the U.S. Food and Drug Administration (FDA). The paper represents the first comprehensive, consensus-based guidance for the design and electronic implementation of event-driven electronic diaries in clinical trials.
On July 29, 2026, C-Path’s Electronic Clinical Outcome Assessment Consortium and Patient-Centered Evidence Consortium presented the collaborative webinar, “Event-Driven eDiaries,” where experts from the co-author panel, including FDA representation, shared the story behind the publication’s genesis, discussed the science that informed the publication’s key recommendations, and discussed real-world implementation considerations in response to questions from attendees.
This work reflects C-Path’s commitment to bringing together regulators, industry, technology providers, and researchers to develop practical, consensus-driven solutions that advance patient-focused drug development.
