UpSMART加速器:推动数字创新,改变早期癌症药物试验的实施

Butt Fouziah, Stephenson Laura, Agnelli Luca, Villalobos Xenia, Carter Louise, Chown Rachel, De Filippo, Damian Silvia, Dienstmann Rodrigo, Formica Elisabetta, Garralda Elena, M. Donna, Graley Andrew, Landers Dónal, O'Regan Paul, Patil Akshita, Regan Aoife, K. Jennifer, Stevenson Julie, Walker Alison, Dive Caroline, H. Andrew
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引用次数: 0

摘要

数字化临床试验为解决I期试验环境中面临的挑战提供了机会,在I期试验环境中,近乎实时的数据捕获和数据解释是迭代决策的先决条件,可以根据新出现的见解快速调整试验设计。尽管数字技术已经推动了许多企业和组织的重大改进,但在临床试验中采用数字技术的速度很慢。为了认识到这一滞后,英国、西班牙和意大利在欧洲建立了UpSMART联盟,这是一个为期5年的资助项目(2020-2024年),旨在拥抱数字技术并为患者带来好处。该联盟由英国癌症研究所曼彻斯特研究所癌症生物标志物中心领导,旨在通过在整个联盟的参与中心之间开源和共享数字医疗保健产品,将英国的实验癌症医学中心和西班牙和意大利的早期药物开发单位“数字化”。目标是优化数据采集和解释,从而加速I期临床研究,最终使患者更快地获得未来的药物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The UpSMART Accelerator: driving digital innovation to change the conduct of early phase cancer medicine trials
Digitalizing clinical trials provide an opportunity to address challenges faced in the Phase I trial settings, where near real-time data capture and data interpretation are prerequisites for iterative decision-making to rapidly adapt trial designs based on emerging insights. Although digital technologies have driven significant improvements in many businesses and organizations, the adoption of digital technologies in clinical trials has been slow. In recognition of this lag, the UpSMART consortium, a 5-year funded program (2020–2024), has been established in Europe between the UK, Spain, and Italy to embrace digital technologies and drive benefits to patients. The consortium, led by the Cancer Research UK Manchester Institute Cancer Biomarker Centre, aims to 'digitalize' Experimental Cancer Medicine Centres in the UK and Early Drug Development Units in Spain and Italy by open-sourcing and sharing digital healthcare products between participating centers across the consortium. The goal is to optimize data capture and interpretation thus accelerating Phase I clinical research to ultimately benefit patients by allowing faster access to tomorrow's medicines.
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