Sample size determination for clinical trials with co-primary outcomes: exponential event times.

Sample size determination for clinical trials with co-primary outcomes: exponential event times.
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DOI:
10.1002/pst.1545
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发表时间:
2013-01
影响因子:
1.5
通讯作者:
Sozu, Takashi
Sozu, Takashi
中科院分区:
医学4区
文献类型:
--
作者:
Hamasaki, Toshimitsu;Sugimoto, Tomoyuki;Evans, Scott;Sozu, Takashi

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以事件-时间结局作为共同主要对比的临床试验在许多领域都很常见,如传染病、肿瘤学和心血管疾病。我们讨论了当至事件发生时间结局呈指数分布时,以两个相关的至事件发生时间结局作为共同主要对比的随机优效性临床试验的样本量计算方法。该方法简单易行,易于实际应用。
Clinical trials with event-time outcomes as co-primary contrasts are common in many areas such as infectious disease, oncology, and cardiovascular disease. We discuss methods for calculating the sample size for randomized superiority clinical trials with two correlated time-to-event outcomes as co-primary contrasts when the time-to-event outcomes are exponentially distributed. The approach is simple and easily applied in practice.
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