Exact confidence limits for the response rate in two-stage designs with over- or under-enrollment in the second stage.

Simon's two-stage design has been widely used in early phase clinical trials to assess the activity of a new investigated treatment. In practice, the actual sample sizes do not always follow the study design precisely, especially in the second stage. When over- or under-enrollment occurs in a study, the original critical values for the study design are no… CONTINUE READING