Could the scientific community be nearing the end of the end of the P value as an efficacy marker in the rare disease drug development space?
It is certainly possible, a panel of experts says
Orphan Drug Development: Could We Be Seeing The End Of P Values?
Panel of experts stresses need to move toward innovative approaches for rare disease drug development such as Bayesian methods, but this would require a paradigm shift in US FDA's regulatory structure.
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