Multidimensional Phase I Dose Ranging Trials for Stroke Recovery Interventions: Key Challenges and How to Address Them

Is the goal to identify the dose to get 100% recovered? If not, then your mentors and senior researchers have set the wrong goal.

Multidimensional Phase I Dose Ranging Trials for Stroke Recovery Interventions: Key Challenges and How to Address Them

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Emily J. Dalton, MOccTherPrac (Hons), Leonid Churilov, PhD, Natasha A. Lannin, PhD, ...

First Published June 4, 2021 Research Article 

https://doi.org/10.1177/15459683211019362

Article information

Abstract

Despite an increase in the amount of published stroke recovery research, interventions have failed to markedly affect the trajectory of recovery post stroke. 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.

Keywords stroke rehabilitation, clinical trials, phase I, dose, maximum tolerable dose, upper limb

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