Adaptive designs for clinical trials with a survival endpoint

Heinz Schmidli, Statistical Methodology, Novartis Pharma AG, CH-4002 Basel, Switzerland

Clinical studies with adaptive design elements can improve the efficiency of drug development. Adaptations such as early stopping for futility or success as implemented in group sequential designs are often implemented for studies with a survival endpoint. Other types of adaptations such as blinded sample size re-estimation and adaptive treatment selection are still underused. In adaptive designs, interim adaptations have to be done quickly. Bayesian methods can help to guide interim decision making.