A decision algorithm for translating preclinical trial results to enhance recovery after stroke.

Full Abstract

A decision algorithm was required to evaluate the first half of a cooperative agreement for preclinical trials to optimize medical device parameters to enhance stroke recovery. Continued funding was contingent upon the midpoint evaluation, called the milestone decision. We developed an algorithm, which summarized our rodent and primate model results. Primary outcomes weighed more heavily than secondary outcomes, and the primate model more heavily than rodent models. By controlling the type I error for this milestone decision, the probability of correctly discontinuing the study if treatment was not beneficial was high (>0.84). Similar algorithms may be adapted for other milestone-driven projects.

Author information

Author/s: Mahnken, Jonathan D (JD); Mayo, Matthew S (MS); Nudo, Randolph J (RJ);

Affiliation: Department of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas 66160, USA. jmahnken(-atsign-)kumc.edu

Grants: 1-U54-NS-48126-1A1 (Agency:NINDS NIH HHS)

Journal and publication information

Publication Type: Journal Article; Research Support, N.I.H., Extramural

Journal: Journal of biopharmaceutical statistics (J Biopharm Stat), published in United States. (Language: eng)

Reference: 2009-; vol 19 (issue 1) : pp 204-16

Dates: Created 2009/01/07; Completed 2009/03/06; Revised 2009/06/25;

PMID: 19127476, status: MEDLINE (last retrieval date: 6/26/2009, IMS Date: 26 Jun 2009 00:00:00)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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