Integrating Phase 2 into Phase 3 based on an Intermediate Endpoint While Accounting for a Cure Proportion

1 code implementation • 4 Jan 2019 • Kaspar Rufibach, Dominik Heinzmann, Annabelle Monnet

Planning for such an interim can be interpreted as making a randomized Phase 2 trial a part of the pivotal trial: if stopped at the interim, the trial would fully read out and a decision on a subsequent Phase 3 trial would be made.

Applications