论文信息 - Interim treatment selection using the normal approximation approach in clinical trials

Interim treatment selection using the normal approximation approach in clinical trials

We consider a study starting with two treatment groups and a control group with a planned interim analysis. The inferior treatment group will be dropped after the interim analysis, and only the winning treatment and the control will continue to the end of the study. This ‘Two‐Stage Winner Design’ is based on the concepts of multiple comparison, adaptive design, and winner selection. In a study with such a design, there is less multiplicity, but more adaptability if the interim selection is performed at an early stage. If the interim selection is performed close to the end of the study, the situation becomes the conventional multiple comparison where Dunnett's method may be applied.

K. K. Lan | Z. Shun | Y. Soo

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