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How soon will digital endpoints become a cornerstone for future drug development?
Drug Discovery Today ( IF 7.4 ) Pub Date : 2018-07-17 , DOI: 10.1016/j.drudis.2018.07.001
Philip Boehme , Arne Hansen , Ronenn Roubenoff , Joseph Scheeren , Maximilian Herrmann , Thomas Mondritzki , Jan Ehlers , Hubert Truebel

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.



中文翻译:

数字端点将在多长时间后成为未来药物开发的基石?

数字技术正在改变医疗保健,并将为制药行业中以患者为中心的创新奠定基础。临床研究中的数字终点具有推动创新并减少代价高昂的后期失败的潜力。监管机构,例如美国食品和药物管理局(FDA),目前也正在考虑这一点。学术界与工业界的合作MOBILISED-D旨在实施和验证现实世界中的步行速度(RWS),这是监管机构公认的首个数字终点。先前的研究表明,老年患者的慢性疾病和虚弱导致的活动能力丧失可能是不同疾病和各种器官系统的相关读数或影响。

更新日期:2018-07-17
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