How soon will digital endpoints become a cornerstone for future drug development?. Issue 1 (January 2019)

• Record Type: Journal Article
• Authors: Boehme, Philip; Hansen, Arne; Roubenoff, Ronenn; Scheeren, Joseph; Herrmann, Maximilian; Mondritzki, Thomas; Ehlers, Jan; Truebel, Hubert
• Is Part Of: Drug discovery today. Volume 24:Issue 1(2019)
• Page Start: 16
• Page End: 19
• Publication Date: 2019-01
• Subjects: Drugs -- Design -- Periodicals; Drugs -- Research -- Periodicals; 615.1
• DOI: 10.1016/j.drudis.2018.07.001
• Languages: English
• ISSNs: 1359-6446

Abstract

Highlights: Late stage failures are decreasing productivity in Pharma R&D. Endpoints, non-reflective of patient needs, are not met causing late stage failure. The FDA encourages the use of digital technology to asses patients' needs. A consortium aims to get regulatory acceptance for real world walking speed. This collaborative approach will ensure patient centric innovation & endpoints. Abstract : Digital technologies are transforming healthcare and will provide the basis for more patient-centric innovation in the pharmaceutical industry. Digital endpoints in clinical studies have the potential to drive innovation and reduce costly late-stage failures. This is also currently under consideration by regulatory agencies, such as the US Food and Drug Administration (FDA). The academic–industrial collaboration MOBILISED-D aims to implement and validate real-world walking speed (RWS) as a digital endpoint accepted by regulatory authorities as a first of its class. Previous work has shown that loss of mobility driven by chronic illness and frailty in older patients can be a relevant readout or effect of different diseases and various organ systems.