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I want to design an RCT (randomised controlled trial) with interim analysis using the O’Brien Fleming interim stoppage criteria to control the Type I error.

I wan to have 3 interim analysis and then the final one then at each analysis I need to have to following p-values to reject $H_0$:

  1. 0.00005
  2. 0.0039
  3. 0.0184
  4. 0.0412

ref

I know these works fine if I use the Wald or Z-statistic $$ Z = \frac{ \delta_j }{ \text{se}(\delta) } = \frac{\hat{p}_2 - \hat{p}_1}{ \sqrt{ \frac{\hat{p}_1\hat{q}_1}{n_1} + \frac{\hat{p}_2\hat{q}_2}{n_2} } } $$

Bu I want to adjust for some covariates and use logistic regression and test if the $\beta$ coefficient of the group variable (no treatment/treatment) is significant.

To test the significance of the $\beta_1$ I will use the Wald ref.

Can I still use the group sequential boundaries for the interim analysis when I use logistic regression to assess the difference between the groups?

If do can someone give me a reference or an explanation of why? If not what else can I do?

This paper states that "the sequential test statistics need to have the independent increments covariance structure in order to control Type I error " and uses an information criteria to control the Type I error ($\alpha$). But I would rather use the O'Brian Flemming boundaries if possible.

drT
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0 Answers0