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Chapter 7. Clinical Trials

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

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

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

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

D. None of the above

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

A. Crossover design

B. Parallel design

C. Adaptive design

D. Factorial design

Why do we randomize trials?

A. To avoid selection bias

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

C. To ensure valid statistical tests

D. All of the above

What makes an ideal primary outcome?

A. One that can be easily dichotomized

B. One that is a short-term endpoint

C. One that is valid and reliable

D. Both A and C

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

A. Phase III

B. Translational

C. Phase II

D. Phase I

Women are considered a vulnerable population.

A. True

B. False

A prognostic variable is

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

B. something to be avoided in trials.

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

D. none of the above.

Sample size estimation is based on

A. the primary outcome.

B. the subgroup ...

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