When study teams require data from questionnaires that were validated on paper, the risk of conservation of equivalence is considerate. To manage that risk when simply shifting from paper to electronic patient-reported outcomes (ePRO), study teams leverage a provisioned hardware solution allowing for a single controlled form factor across all patients. Provisioned ePRO supports testing for equivalence on that form factor only to support an equivalence claim historically managing that risk well. However, this solution is costly, hardware inventory-dependent, and resource demanding.
Bring your own device (BYOD) solutions offer a disruptive alternative to the costly provisioned solutions for ePRO but have been mostly overlooked and only moderately considered due, in part, to this question of equivalence and to concerns for patients accepting study tools on their own phones. In this webinar, the featured speakers will discuss a recent study where leveraging the most widely used response scale types equivalence for BYOD was explored both through patient self-report and through a three-way crossover study assessing subscale scores from paper measures migrated to electronic format and implemented on provisioned and BYOD solutions.
Further, the speakers will discuss some of the common risks and concerns to be considered when evaluating a BYOD solution for your ePRO endpoints. Among these, the experts will explore solutions for overcoming issues including:
- Patient phone upgrades
- Lost or stolen phones
- How to determine which patient phones are supported and which ones aren’t
- Challenges for Android and Apple solutions (both must be supported)
- Data plan support
- Hybrid BYOD/provisioned support
Join this webinar for a discussion of the question of Phases for BYOD and ePRO endpoints. The speakers will explore the differences when thinking of Phase I, II, III, and IV and the current trends.
Kyle Hogan, eClinical Solutions Director, Clinical Ink
Kyle Hogan is the eClinical Solutions Director with Clinical Ink. He is responsible for the strategic alignment of the company’s native mobile application for clinical trials, SureSource Engage. Kyle has delivered technical solutions for complex business challenges since the1990s and has 10+ years of experience in clinical trials. He has managed numerous global ePRO trial deployments and developed a mobile patient training solution for eCOA. Kyle is an industry expert in realizing fully BYOD capable eCOA, patient engagement, and connected sensor solutions through mobile applications for use by patients in clinical trials.
Willie Muehlhausen, Vice President, Head of Innovation, ICON plc
Willie Muehlhausen has been involved in the capture and migration of PROs for 20 years. During his career he worked with multiple technologies to capture PRO data and in 2009 he started his research program to understand BYOD and its implications. In collaboration with multiple organizations (sponsors and vendors) his team conducted and published several unique studies i.e. first BYOD equivalence study, all trying to establish a basic understanding how different technologies influence patient´s responses.
Who Should Attend?
- ePRO / ePRO Category / Data Managers
- Clinical Trial / Clinical Study Leads
- Therapeutic Strategy Leads
- Biometrics / Bio Stats Managers
- Clinical Operations Specialists
- Clinical Operations Directors / VPs
Founded in 2007, Clinical Ink® is transforming clinical development with innovative technologies that make clinical research easier for sites, sponsors and patients. Clinical Ink’s SureSource® comprehensive platform directly captures eSource data and documents and improves patient engagement by focusing on the critical moments that matter when executing the protocol. Clinical Ink maintains offices in Cambridge, MA, Winston-Salem, NC, and Philadelphia, PA. Find more at www.clinicalink.com.