Event Date/Time: Mar 26, 2010
There has been increasing interest in applying adaptive clinical trials throughout the various stages of clinical development. This conference will provide an overview of the FDA draft guidance on the topic of adaptive designs, and an opportunity for discussion of some topics involved with the implementation of adaptive clinical trial design in drug development and approval. The FDA will summarize the guidance content and highlight areas where they feel comments to the official Docket would be most helpful. There will be opportunities to seek clarifications of issues raised in the guidance. Study sponsors will discuss practical examples of designing and conducting clinical trials using adaptive designs for regulatory approval and focus on how to address potential concerns about adaptive designs.
Due to their complexity, adaptive design development programs require more (and earlier) planning and documentation. The conference will present how this planning should be summarized and discussed with the FDA prior to implementing an adaptive trial.