Electronic Patient Diaries in a Clinical Trial—The Holistic Approach

Abstract

Diaries are commonly used in clinical research for collecting self-reported subject data. Subject noncompliance and poor data quality are associated with the use of paper diaries. In the fall of 2001, we conducted a phase 2 trial in which we used electronic patient diaries to collect the primary outcome measure data. We enrolled 1069 healthy subjects who answered questions about study medication dosing, cold symptoms, and adverse events daily for eight weeks. On a daily basis, subjects downloaded data to a central database using a phone line. Study coordinators reviewed diary responses using a Web-based application, thus facilitating subjects' compliance with the protocol. If the subject reported a cold or an adverse event, the coordinator was to contact the subject to schedule a clinic visit. We found that electronic patient diaries lead to complete data that were of a higher quality than similar paper diaries. Site personnel and subjects easily adopted electronic patient diaries.