Update of the stroke therapy academic industry roundtable preclinical recommendations.

Abstract:

:The initial Stroke Therapy Academic Industry Roundtable (STAIR) recommendations published in 1999 were intended to improve the quality of preclinical studies of purported acute stroke therapies. Although recognized as reasonable, they have not been closely followed nor rigorously validated. Substantial advances have occurred regarding the appropriate quality and breadth of preclinical testing for candidate acute stroke therapies for better clinical translation. The updated STAIR preclinical recommendations reinforce the previous suggestions that reproducibly defining dose response and time windows with both histological and functional outcomes in multiple animal species with appropriate physiological monitoring is appropriate. The updated STAIR recommendations include: the fundamentals of good scientific inquiry should be followed by eliminating randomization and assessment bias, a priori defining inclusion/exclusion criteria, performing appropriate power and sample size calculations, and disclosing potential conflicts of interest. After initial evaluations in young, healthy male animals, further studies should be performed in females, aged animals, and animals with comorbid conditions such as hypertension, diabetes, and hypercholesterolemia. Another consideration is the use of clinically relevant biomarkers in animal studies. Although the recommendations cannot be validated until effective therapies based on them emerge from clinical trials, it is hoped that adherence to them might enhance the chances for success.

journal_name

Stroke

journal_title

Stroke

authors

Fisher M,Feuerstein G,Howells DW,Hurn PD,Kent TA,Savitz SI,Lo EH,STAIR Group.

doi

10.1161/STROKEAHA.108.541128

subject

Has Abstract

pub_date

2009-06-01 00:00:00

pages

2244-50

issue

6

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.108.541128

journal_volume

40

pub_type

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