Clinical Forum for Operational Excellence

The development of adaptive designs started more than 20 years ago and since then not only the number of potential designs went up but also their acceptability within companies and by regulators. In essence, adaptive designs are already today frequently part of standard design options for clinical studies, in early as well as in late development. Adaptive designs have the potential to speed up development or save cost or increase probability of success depending on the context. The discussion on adaptive designs concentrated a lot on theoretical parts, on how to maintain type 1 error or how to ensure integrity of the trial, less on the operational consequences in their implementation. This session will provide an overview on adaptive designs in the first part, but then concentrate on operational aspects. Especially, when using adaptive designs to control cost, operational aspects are critical and more information and experience will be shared on these aspects in this session.