Perspective on adaptive designs: 4 years European Medicines Agency reflection paper, 1 year draft US FDA guidance - where are we now?

摘要

Adaptive clinical trials attract great attention from academia, industry and regulatory authorities. Both the European Medicines Agency and the US FDA have clarified their positions in recently issued (final or draft) guidance documents. With this background, current trends and issues were analyzed in a panel discussion at the International Society for Biopharmaceutical Statistics (ISBS) meeting in March 2011. In this article, members of the panel summarize their thoughts based on this discussion.