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PSI Conference 2018: Case studies in Flexible Designs for Confirmatory Clinical Trials

05 June 2018

Considerable interest has grown among pharmaceutical and other medical product developers in adaptive clinical trials, in which data collected during the course of a trial affects ongoing conduct or analysis of the trial. Following the release of the FDA draft Guidance document on adaptive design clinical trials in early 2010, expectations of an increase in regulatory submissions involving adaptive design features, particularly for confirmatory trials, were high. In this session we present a couple of case studies where adaptive designs were applied in a confirmatory setting as well as the statistical challenges resulting from the implementation of such designs. Recommendations will also be provided.

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