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 Campbell, Kathryn S Hayward
NEUROREHABILITATION AND NEURAL REPAIR | SAGE PUBLICATIONS INC | Published : 2021
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 de..View full abstract
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Awarded by National Health and Medical Research Council
Awarded by Heart Foundation Future Leader Fellowship
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by an Australian Government Research Training Program Scholarship (ED); National Health and Medical Research Council (KH: 1088449; BC: 1174514), and Heart Foundation Future Leader Fellowship (NL: GNT102055).