Internal pilot studies for estimating sample size

Martin A. Birkett; Simon J. Day

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Internal pilot studies for estimating sample size

机译：用于估计样本量的内部试点研究

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AbstractWe develop the idea of using data from the first ‘few’ patients entered in a clinical trial to estimate the final trial size needed to have specified power for rejectingH0in favour ofH1if a real difference exists. When comparing means derived from Normally distributed data, there is no important effect on test size, power or expected trial size, provided that a minimum of about 20 degrees of freedom are used to estimate residual variance. Relative advantages and disadvantages of using larger internal pilot studies are presented. These revolve around crude expectations of the final study size, recruitment rate, duration of follow‐up and practical constraints on the ability to prevent the circulation of unblinded randomization codes to investigators and those involved in editing and checking

机译：摘要我们提出了使用临床试验中进入的第一批“少数”患者的数据来估计最终试验规模，如果存在真正的差异，则需要具有特定能力来拒绝H0以支持H1。在比较从正态分布数据得出的均值时，如果使用至少大约 20 个自由度来估计残差方差，则对测试规模、功效或预期试验规模没有重要影响。介绍了使用更大规模的内部试点研究的相对优点和缺点。这些围绕着对最终研究规模、招募率、随访持续时间的粗略期望，以及防止将非盲随机化代码分发给研究人员和参与编辑和检查的人员的能力的实际限制

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《statistics in medicine》 |1994年第23‐24期|2455-2463|共页
作者
Martin A. Birkett; Simon J. Day;
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Internal pilot studies for estimating sample size

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