The study was based on a Simon’s optimal two-stage design [14]. The assumptions were that the hematologic improvement rate would be non-existent without this intervention and any hematologic improvement would be beneficial to the patient population. Therefore, the null hypothesis was that the current response rate was 0.01 (approximately 0) which was to be tested against a one-sided alternative of a 10% hematologic improvement rate. Should the futility criteria for stopping not be met, 17 patients were to be accrued in the first stage. If one or more participants experience hematologic improvement then the study would continue to the second stage, otherwise the study would have stopped for lack of efficacy. During stage 2, an additional 22 patients for a total of 39 were to be enrolled. If two or more responses were observed in the 39 patients, the null hypothesis that the intervention is ineffective would have been rejected. This design yields a type I error rate of 0.04 and power of 80%.

注意:以上内容是从某篇研究文章中自动提取的,可能无法正确显示。



Q&A
请登录并在线提交您的问题
您的问题将发布在Bio-101网站上。我们会将您的问题发送给本研究方案的作者和具有相关研究经验的Bio-protocol成员。我们将通过您的Bio-protocol帐户绑定邮箱进行消息通知。