Title: Design elements and compliance of electronic participant-reported reactogenicity diaries in respiratory vaccine studies
Dates and times:
Abstract:
In vaccine clinical trials, the need for collecting high quality data in an expedited fashion has paved the way for the implementation of electronic vaccine diaries (eDiaries). Participant-reported symptoms using eDiaries is a relevant tool that allows participants to report their post-vaccination symptoms in real time. We explored data from three respiratory clinical studies across various phases and indications for design elements and participant compliance with vaccine eDiaries using Clario’s application.
Result:
All eDiaries were reactogenicity diaries collecting common vaccine symptom data, one eDiary asked about additional symptoms. The eDiaries varied in their preciseness of instructions and did not allow retroactive completion. eDiaries included caregiver reporting options and participants were either given a provisioned device or the choice to either use their own device (BYOD) or a provisioned device to report their symptoms. Compliance for the eDiaries was high.
Conclusion:
This exploratory analysis proposes that eDiaries are effective in engaging participants to report their post-vaccination symptoms in vaccine clinical trials.
Ingeborg de Gooijer is Science Communications Manager at Clario eCOA Science with over 6 years experience in clinical research. She brings over 25 years of experience in strategic marketing, marketing communications and writing experience to the role to lead communication and thought leadership activities for the team. Prior to Clario, Ingeborg worked with health care clients for 10 years in an agency capacity. Ingeborg holds an MBA with Data Analytics and a BA in Marketing.