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

A decision algorithm for translating preclinical trial results to enhance recovery after stroke.
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DOI:
10.1080/10543400802536271
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发表时间:
2009
影响因子:
1.1
通讯作者:
Nudo RJ
Nudo RJ
中科院分区:
医学4区
文献类型:
--
作者:
Mahnken JD;Mayo MS;Nudo RJ

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需要一种决策算法来评估临床前试验合作协议的前半部分,以优化医疗器械参数,提高卒中恢复。继续供资取决于中期评价,即里程碑决定。我们开发了一种算法,总结了我们的啮齿动物和灵长类动物模型的结果。主要结果比次要结果更重要,灵长类动物模型比啮齿动物模型更重要。通过控制该里程碑决策的I类错误,如果治疗无效,则正确终止研究的概率很高(>0.84)。类似的算法可以适用于其他里程碑驱动的项目。
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.
DOI: 10.1016/s1052-3057(03)00042-9
发表时间: 2003-05-01
期刊: Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
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