The Value of the Information That Can Be Generated: Optimizing Study Design to Enable the Study of Treatments Addressing an Unmet Need for Rare Pathogens
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DOI: 10.1093/ofid/ofac266
Abstract: Abstract In traditional phase 3 trials confirming safety and efficacy of new treatments relative to a comparator, a 1-sided type I error rate of 2.5% is traditionally used and typically leads to minimum sizes of… read more here.
Keywords: information generated; value information; rare pathogens; unmet need ... See more keywords