Key Elements of a Successful Phase III Study
Key Elements of a Successful Phase III Study
Key Elements of a Successful Phase III Study
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• Analyses<strong>Study</strong> Design– Outcome measures: Primary and secondary• Unambiguous, accurately measured, clinicallymeaningful: overall survival (or intermediate orsurrogate endpoint) or improvement in quality <strong>of</strong> life ordisease related symptoms.– Intent: test superiority or equivalence or noninferiority– Sample size and final analysis (time to eventanalysis): effect size, Type I and II errorrates, event rate, duration <strong>of</strong> accrual andfollow-up
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