Abstract
Regulators show some flexibility in the evidentiary standards of effectiveness that must be demonstrated for a drug prior to its market authorization. Adopting a more formal framework for when and how effectiveness standards should vary would improve the therapeutic value of new medicines at the time of market entry. We identify three factors-the number and effectiveness of existing treatment alternatives, magnitude of unmet need, and expected clinical application-to guide the effectiveness threshold for a given therapy. Using these factors, regulators should actively guide sponsors regarding appropriate comparators and end points in pivotal trials, as well as determining the size and characteristics of the patient populations enrolled.
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