SOME THOUGHTS ON CLINICAL-TRIALS, ESPECIALLY PROBLEMS OF MULTIPLICITY
SOME THOUGHTS ON CLINICAL-TRIALS, ESPECIALLY PROBLEMS OF MULTIPLICITY
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DOI：
10.1126/science.333584
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发表时间：
1977-01-01
期刊：
影响因子：
56.9
通讯作者：
TUKEY, JW
中科院分区：
文献类型：
--
作者：
TUKEY, JW
许多(如果不是大多数)临床试验中的伦理问题加剧了实验的统计和概念设计问题。对证明有效性的法定要求远未得到明确解决--无论是定性的还是定量的。在知情同意的支持下，伦理很可能使我们永远无法了解许多问题的答案。不平衡的边界、向下聚焦的设计、历史控制以及不是非常循序渐进的设计都是可能的后果。
Problems of statistical and conceptual design of experiments are exacerbated by ethical issues in many, if not most, clinical trials. Statutory requirements of demonstrated effectiveness are far from being clearly resolved—either qualitatively or quantitatively. Ethics, bolstered by informed consent, are likely to keep us from ever learning the answer to many questions. Unbalanced boundaries, focusing-down designs, historical controls, and not-very-sequential designs are among the possible consequences.