Bring Your Own Device (BYOD) eCOA - Instrument Validation Methodology

Presented by

Dr.Wilhelm Muehlhausen, Head of Innovation, ICON

About this talk

Current guidance from the FDA and ISPOR (2009) recommends that when a Patient Reported Outcome (PRO) instrument is migrated between different modalities (for example, from a paper PRO to an electronic (ePRO) format), empirical evidence is required in order to demonstrate that the measurement properties of the ePRO application are comparable if not superior to the original PRO format. In the case of a migration of a paper instrument to an electronic device, when non-substantive changes are made (i.e. changing ‘circle’ on paper to ‘select’ or ‘click’ on an electronic device; or minor changes in format such as one item per screen rather than multiple items on a page) this qualifies as a minor modification. According to good practice guidelines (Coons et al; 2009), this should be addressed through cognitive debriefing and usability testing interviews in the population of interest. However, with the advent of web-based instruments and bring-your-own-device (BYOD), validation becomes more challenging: due to an increasingly diverse range of mobile phones and tablets on the market, with varying screen sizes, operating systems etc. This webinar discusses how we can develop a methodology and minimum standards for migrating instruments that would be applicable to any device. Key Insights - Introduce the concept of BYOD - Regulatory expectations and current best practices in PRO migration to electronic devices - Highlight the challenges that the current regulatory environment poses to BYOD concepts - Provide an in-depth case study of developing a process to migrate a specific instrument, the ACTS, to electronic format. The process that was developed for migrating this instrument. Presenters: Dr. Wilhelm Muehlhausen, Head of Innovation, ICON; Kai Langel, Director Patient Solutions, eClinical Health; Program development: Helen Marson-Smith, Outcomes Researcher, Clinical Outomes Assessment, ICON

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