W-10: The Rise of Electronic Patient-Recorded Outcomes in Oncology (ePRO)
Synteract United States
The objective of this study is to identify and assess key drivers for ePRO app development as well as the best potential countries to utilise in a clinical study for the approval of ePRO platforms.
For this study, we will review literature and databases from existing investigations that include PRO, medical devices (apps) and ePRO focusing on studies within oncology.
Quantitative data includes:
- Smartphone Landscape (usage) and market share (iPhone vs Android) – this is important in app develop as a sponsor would need to select which OS to base their app on.
- Language landscape in Europe – which covers the best language to design the app around initially and then which languages to develop downstream.
- The prevalence of the four most predominant cancers.
- Previous study performance within e-health and enrolment rate analysis.
- This study shows that ePRO has shown improvement in patient outcomes.
- The key drivers to selecting countries and the key success criteria for recruitment of patients.
- The best countries to develop an ePRO app in within Europe and to what parameters (language, smart phone market share, prevalence of cancers etc) would be an outcome of this study.
- The enrolment rates for ePRO/ e-health studies will be shown to conclude what the landscape looks like to help input into operational strategies etc.
- The robustness of the findings was bolstered by combining a range of data sources and types with additional data from Synteract and those from literature and open sources, including a review of previous investigations into ePRO.