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Chapter 7. Clinical Trials

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What are the properties that classify research as a clinical trial?

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A. A prospective experiment of an intervention with a control group that is conducted in humans

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B. The retrospective analysis of data that was collected on humans exposed to a certain intervention

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C. The testing of a new intervention on humans or animals

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D. None of the above

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What type of design would allow one to study an interaction effect?

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A. Crossover design

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B. Parallel design

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C. Adaptive design

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D. Factorial design

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Why do we randomize trials?

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A. To avoid selection bias

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B. To ensure treatment assignment balance within a certain prognostic variable

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C. To ensure valid statistical tests

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D. All of the above

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What makes an ideal primary outcome?

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A. One that can be easily dichotomized

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B. One that is a short-term endpoint

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C. One that is valid and reliable

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D. Both A and C

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What phase of clinical trial development assesses what dose to use?

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A. Phase III

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B. Translational

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C. Phase II

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D. Phase I

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Women are considered a vulnerable population.

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A. True

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B. False

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A prognostic variable is

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A. a variable that impacts the outcome regardless of treatment.

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B. something to be avoided in trials.

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C. a variable that impacts the outcome because of treatment.

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D. none of the above.

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Sample size estimation is based on

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A. the primary outcome.

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B. the subgroup ...

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