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Multidimensional Phase I Dose Ranging Trials for Stroke Recovery Interventions: Key Challenges and How to Address Them
Neurorehabilitation and Neural Repair ( IF 3.7 ) Pub Date : 2021-06-04 , DOI: 10.1177/15459683211019362
Emily J Dalton 1 , Leonid Churilov 1 , Natasha A Lannin 2, 3 , Dale Corbett 4 , Bruce C V Campbell 1, 5 , Kathryn S Hayward 1, 6
Affiliation  

Despite an increase in the amount of published stroke recovery research, interventions have failed to markedly affect the trajectory of recovery poststroke. We argue that early-phase research to systematically investigate dose is an important contributor to advance the science underpinning stroke recovery. In this article, we aim to (a) define the problem of insufficient use of a systematic approach to early-phase, multidimensional dose articulation research and (b) propose a solution that applies this approach to design a multidimensional phase I trial to identify the maximum tolerated dose (MTD). We put forward a design template as a decision support tool to increase knowledge of how to develop a phase I dose-ranging trial for nonpharmaceutical stroke recovery interventions. This solution has the potential to advance the development of efficacious stroke recovery interventions, which include activity-based rehabilitation interventions.



中文翻译:

中风恢复干预的多维 I 期剂量范围试验:主要挑战以及如何应对

尽管已发表的中风恢复研究数量有所增加,但干预措施未能显着影响中风后恢复的轨迹。我们认为,系统地研究剂量的早期研究是推动支持中风康复的科学的重要贡献者。在本文中,我们旨在 ( a ) 定义在早期、多维剂量表达研究中使用系统方法不足的问题,以及 ( b )) 提出了一种解决方案,将这种方法应用于设计多维 I 期试验以确定最大耐受剂量 (MTD)。我们提出了一个设计模板作为决策支持工具,以增加对如何为非药物性卒中康复干预开发 I 期剂量范围试验的知识。该解决方案有可能推动有效的中风康复干预措施的发展,其中包括基于活动的康复干预措施。

更新日期:2021-06-04
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