Update of the stroke therapy academic industry roundtable preclinical recommendations.
Update of the stroke therapy academic industry roundtable preclinical recommendations.
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DOI：
10.1161/strokeaha.108.541128
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发表时间：
2009-06
期刊：
影响因子：
8.3
通讯作者：
STAIR Group
中科院分区：
文献类型：
--
作者：
Fisher M;Feuerstein G;Howells DW;Hurn PD;Kent TA;Savitz SI;Lo EH;STAIR Group
1999年发表的卒中治疗学术行业圆桌会议（STAIR）最初的建议旨在提高急性卒中治疗的临床前研究质量。虽然这些建议被认为是合理的，但没有得到严格遵守，也没有得到严格验证。关于候选急性卒中治疗的临床前试验的适当质量和广度，已经取得了实质性进展，以更好地进行临床转化。更新后的STAIR临床前建议强化了先前的建议，即在适当的生理监测下，在多个动物种属中可重复地定义具有组织学和功能结局的剂量反应和时间窗是适当的。更新后的STAIR建议包括：应遵循良好科学调查的基本原则，消除随机化和评估偏倚，先验地定义纳入/排除标准，进行适当的把握度和样本量计算，并披露潜在的利益冲突。在年轻、健康的雄性动物中进行初步评价后，应在雌性、老龄动物和患有高血压、糖尿病和高胆固醇血症等共病的动物中进行进一步研究。另一个考虑因素是在动物研究中使用临床相关的生物标志物。尽管这些建议在临床试验中出现有效的治疗方法之前无法得到验证，但人们希望遵守这些建议可能会增加成功的机会。
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.