The pharmaceutical industry has seen a considerable interest and increase in the application of adaptive designs, particularly after the publication of the FDA Draft Guidance on Adaptive Design in 2010. Adaptive design has the potential to reduce the cost and length of drug development and/or improve the probability of success and de-risk drug development. However, uncertainty and questions surround the use of adaptive design. This basic to intermediate level course will identify opportunities in early and late phase development where adaptive design may be applied and use practical examples to demonstrate how to appropriately design and implement such trials in consensus with FDA Guidance.
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