Abstract:
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In late stage drug development in neuroscience area, a substantial number of study failures were due to unexpected placebo response. There is a trend of increasing placebo response over the years in several disease areas. Researchers are addressing the unexpected placebo response phenomenon by using innovative study design strategies. In order to increase the probability of success in late stage programs, it is critical to identify the potential sources of placebo response in the early stage of clinical development, and explore different scenarios of the placebo response in decision making. Subsequently, the magnitude and variability of the placebo response can be well predicted for the late phase studies after a GO decision is made, and simultaneously the probability of success in late stage programs can be expected to increase. Examples from literature and simulations will be given to illustrate the scenarios of placebo response related to false positives and false negatives in decision making.
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