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A Study Is Designed to Evaluate the Efficacy of a New

question 104

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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?

Identify the limitations and challenges associated with internal controls.
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Definitions:

Research Hypothesis

An educated guess or prediction made for the purpose of testing through scientific research, stating a potential outcome or relationship.

Critical Values

Thresholds in hypothesis testing which, if exceeded by the test statistic, indicate that the null hypothesis can be rejected.

Standard Deviation

A metric that quantifies how spread out a dataset is in comparison to its average value.

Standard Error

The standard deviation of the sampling distribution of a statistic, often used to calculate confidence intervals or test hypotheses.

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