ABSTRACT
The U.S. Food and Drug Administration (FDA) recognizes in their critical path initiative that drug development is increasingly expensive with successful development of a single drug costing around $2 billion (FDA 2004). The initiative aims to make drug development more efficient and was described as a “serious attempt to bring attention and focus to the need for more scientific effort and for more publicly available information about the evaluation tools used in product development” (O’Neill 2006, p. 559). The initial white paper was followed up by an opportunity list that mentions adaptive designs as one potential remedy to make drug development more efficient (FDA 2006).
