| Abstract: | A flexible method is proposed for group sequentially performed clinical trials which allows for an adaptive, data‐driven sample size reassessment at each stage. By also adaptively assigning different weights to the several stages the total number of study parts can be steered to an intended early or late end of the trial in dependence on all information available prior to a stage. Although at each stage the null hypothesis is tested on rejection, the full level‐α‐test is preserved at the end of the study. The proposed method is not restricted to normally distributed responses. The discussed adaptive designing is a useful tool provided that a priori information about parameters involved in the trial are not available or subject to uncertainty. The presented learning algorithm enables the complete self‐designing of a study. |
