Short description: Efficacy and safety is currently proven mainly with data measured at clinical sites. Use of wearables and e-questionnaires enable continuous digital biomarkers from real life of patients. This requires use of modern tools and data analytics.
Market potential: Huge potential as a reimbursed digital endpoint in product label (hundreds of millions in peak sales) – it can be replicated to other products (scalability).
Timing: ASAP, few projects on going in clinical phase, and almost all future projects are assessed to use these approaches. Results visible in a few years.
Desired result: Modern and novel data analytical services (e.g. AI model, statistical results) for a clinical development program of a new pharma product.
Information on challenge owner: Large company (> 3,000 staff).
Market presence of challenge owner: Global presence.
Keywords: Digitalbiomarkers; Real world data; Modern data analytics; Clinical trials; Wearables