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

Emily J. Dalton, Leonid Churilov, Natasha A. Lannin, Dale Corbett, Bruce C.V. Campbell, Kathryn S. Hayward

Research output: Contribution to journalArticleResearchpeer-review

10 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)663–679
Number of pages17
JournalNeurorehabilitation and Neural Repair
Volume35
Issue number8
DOIs
Publication statusPublished - Aug 2021

Keywords

  • clinical trials
  • dose
  • maximum tolerable dose
  • phase I
  • stroke rehabilitation
  • upper limb

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