Update of the stroke therapy academic industry roundtable preclinical recommendations.
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.
Fisher
Marc
M
Department of Neurology, University of Massachusetts Medical School, Worcester, MA 01605, USA. fisherm@ummhc.org
Feuerstein
Giora
G
Howells
David W
DW
Hurn
Patricia D
PD
Kent
Thomas A
TA
Savitz
Sean I
SI
Lo
Eng H
EH
D000818:Animals; D002545:Brain Ischemia / Q000150:complications; D004195:Disease Models, Animal; D017408:Guidelines as Topic; D019981:Health Care Sector; D006801:Humans; D012106:Research; D013045:Species Specificity; D020521:Stroke / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome