A Study Is Designed to Evaluate the Efficacy of a New

question 104

Multiple Choice

A study is designed to evaluate the efficacy of a new drug, KM28.  The study will compare KM28 plus standard care versus standard care alone with regard to decreasing the incidence of recurrent breast cancer.  The Food and Drug Administration (FDA) will approve the new drug if KM28 plus standard care decreases the rate of breast cancer recurrence by at least 40% compared to standard therapy alone.  The recurrence rate on standard therapy is found to be 8%.  In order for the FDA to approve KM28, what is the maximal incidence of recurrent disease acceptable for women treated with KM28 plus standard therapy?

• A)2.8%
• B)3.2%
• C)3.6%
• D)4.8%
• E)5.2%

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