During the past decade we have seen increasing interest in adaptive trial designs, and with the release of regulatory agency guidelines a cautious encouragement and acceptance of the methodology now prevails. Nevertheless, while the promise of these designs is acknowledged, the operational challenges in their implementation are less well understood. Through three presentations, this session explores different aspects of practical implementation of adaptive clinical trials in clinical development programs. We will focus on practical implementation learning using case study illustrations where possible.

Learning Objectives:
Discuss how clinical trials technologies enable the effective implementation of adaptive trials
Describe and appraise different supply planning, manufacture, packaging, and labeling strategies for adaptive trials: Describe the operation of the data monitoring committee and how to manage interim analyses and study stopping effectively.