Session (CTI)

Developing meaningful measures of patient health, function, and daily life is key to understanding the value of interventions and to ensure patient access. Contrary to traditional clinical trials where endpoints and biomarkers are collected at clinic visits, digital technologies enable passive real-time health data collection from wearables, smartphones, and other connected devices. While these technologies offer the opportunity to reflect outcomes more relevant to patients in their daily lives, issues such as equity in access, usability, and data privacy can also arise. This forum will explore three perspectives on how digital technologies can be developed to represent outcomes which improve access. The process of clinical trial implementation and regulatory acceptance of digitally derived patient data will be provided by the first speaker. A medical device developer will cover issues related to enabling improved data capture, real-time monitoring, and continuous evaluation. Ultimately, the power of digital technologies relies on their meaningfulness to patients, which will be addressed from the lens of a patient/carer representative. This session convenes experts from four Special Interest Groups (Digital Health, Medical Devices and Diagnostics, Clinical Outcome Assessment and Patient-Centered). Panelists will share experiences and offer solutions to align expectations of the promise of digital technologies to represent meaningful differences across regulatory, manufacturer, patient and payer perspectives.