Bayer Pharma AG, Cardiovascular Research, Wuppertal, Germany; Witten/Herdecke University, School of Medicine, Faculty of Health, Witten, Germany.
Witten/Herdecke University, School of Medicine, Faculty of Health, Witten, Germany; Johnson & Johnson Medical GmbH, Production Planning & Logistics, Norderstedt, Germany.
Drug Discov Today. 2019 Jan;24(1):16-19. doi: 10.1016/j.drudis.2018.07.001. Epub 2018 Jul 17.
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.
数字技术正在改变医疗保健行业，并将为制药行业提供更多以患者为中心的创新基础。临床研究中的数字终点有可能推动创新并减少昂贵的后期失败。这也是监管机构（如美国食品和药物管理局（FDA））目前正在考虑的问题。学术-工业合作 MOBILISED-D 的目的是实施和验证作为监管机构认可的同类首创的真实世界行走速度（RWS）作为数字终点。先前的工作表明，由慢性疾病和老年患者的虚弱导致的移动能力丧失可能是不同疾病和各种器官系统的相关读出或影响。
