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Abstract:
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The landscape of drug development continues to evolve spurred by new therapeutic discoveries, increased understanding of disease mechanisms, the need for innovation to optimally use resources, and global public health crises. As a result of this evolution, the U.S. Food and Drug Administration (FDA) and medical product developers are faced with unique challenges and opportunities. FDA is proactively meeting the challenges through various efforts centered around the appropriate use of complex innovative trial designs, which hold the promise of improving clinical trial efficiency with scientific methods that reliably answer the questions of interest. This talk will focus on the impact of the efforts, past, present, and future, aimed at advancing the use of complex innovative trial designs in drug development with an ultimate goal of bringing safe and effective medical products to patients.
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