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Stroke research at a road block: the streets from adversity should be paved with meta‐analysis and good laboratory practice
Author(s) -
Dirnagl Ulrich,
Macleod Malcolm R
Publication year - 2009
Publication title -
british journal of pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.432
H-Index - 211
eISSN - 1476-5381
pISSN - 0007-1188
DOI - 10.1111/j.1476-5381.2009.00211.x
Subject(s) - publication bias , meta analysis , stroke (engine) , clinical trial , medicine , psychology , alternative medicine , neuroprotection , medline , systematic review , medical education , pharmacology , political science , pathology , engineering , mechanical engineering , law
In this issue, Bath et al. use state of the art meta‐analytical tools to address the pressing question of why NXY‐059, a compound at the time considered to fulfil all the recommendations for the evaluation of preclinical data regarding neuroprotective drugs, has failed clinically. They demonstrate quantitatively that a negative publication bias existed, that the compound was indeed neuroprotective in experimental stroke, but that bias may have resulted in an overestimation of efficacy, and that efficacy in healthy, male, adolescent animals is a poor predictor of success in clinical trial. The study contains important messages for researchers, journal editors, the pharmaceutical industry and science policy makers. Bias is both prevalent and relevant in experiments modelling human stroke. Simple measures can reduce, perhaps substantially, the impact of such bias. The decision to proceed to clinical trial should be based on a thorough and systematic review of the animal data.