Session (CTI)

Digital health Technology (DHTs) are being used more frequently to generate patient experience data and measure outcomes in drug development. Applying patient focused approaches when using DHT derived Clinical Outcome Assessments (COA) requires additional considerations to ensure these measures reflect the symptoms and treatment impacts that matter to patients. In addition, participant input into the DHT selection process is essential and there is likely to be a requirement to demonstrate the useability of the DHT in the given context of use should the digital measures be used as part of health authority engagements. Both are essential when it comes to ensuring the correct anchors are selected, and that sufficient data is collected to support the determination of meaningful change thresholds and the endpoint analysis plan. Considering the perspective of patient, industry and health authorities, this panel will review the challenges when designing patient centric trials that utilize DHT’s, and share experiences in incorporating patient insight to ensure that both the endpoints and DHT selected adequately reflect the voice and experience of the patient.