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Abstract:
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In 2005, I was assigned to support experimental medicine studies. I now report to the head of early development biostat in Merck Research Labs. Littman & Williams [Nature Reviews, 2005] define experimental medicine as "the use of innovative measurements, models, and designs in studying human subjects for establishing proof of mechanism and concept of new drugs, for exploring the potential for market differentiation for successful drug candidates, and for efficiently terminating the development of unsuccessful ones." While this effort in Merck is still forming, much of my work thus far has involved examination of how dose-adaptive study designs and N-of-1 trials can be implemented for proof-of-concept (PoC) trials and application of classical methods to specific clinical trials of novel endpoints. This luncheon offers an opportunity to share ideas in this area.
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