Multidimensional Phase I Dose Ranging Trials for Stroke Recovery Interventions: Key Challenges and How to Address Them
Multidimensional Phase I Dose Ranging Trials for Stroke Recovery Interventions: Key Challenges and How to Address Them
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DOI：
10.1177/15459683211019362
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发表时间：
2021-06-04
影响因子：
4.2
通讯作者：
Hayward, Kathryn S.
中科院分区：
文献类型：
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作者：
Dalton, Emily J.;Churilov, Leonid;Hayward, Kathryn S.
尽管已发表的卒中恢复研究数量有所增加，但干预措施未能显著影响卒中后恢复的轨迹。我们认为，早期研究，系统地调查剂量是一个重要的贡献，以推进科学支持中风恢复。在这篇文章中，我们的目的是（a）定义的问题，不充分使用的系统方法，早期阶段，多维剂量衔接研究和（B）提出一个解决方案，应用这种方法来设计一个多维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，以增加知识，如何开发一个I期剂量范围试验的非药物中风恢复干预措施。该解决方案有可能促进有效的中风康复干预措施的开发，其中包括基于活动的康复干预措施。
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.