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Chapter 5. Literature Evaluation II: Beyond the Basics

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Please select the best answer regarding which study design is presented.

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A crossover study to prospectively evaluate the use of an anticonvulsant drug for treatment of peripheral neuropathy in an individual patient.

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a. Case study

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b. Case report

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c. N-of-1 study

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Please select the best answer regarding which study design is presented.

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A patient develops agranulocytosis after administration of dronedarone. The clinician writes and publishes this single patient observation.

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a. Case report

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b. Case series

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c. N-of-1 study

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Please select the best answer regarding which study design is presented.

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An investigator evaluates the question of whether or not different digoxin products can be used interchangeably.

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a. Case series

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b. Bioequivalence

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c. Postmarketing

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d. Stability

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Please select the best answer regarding which study design is presented.

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A company designs a trial to show that their new drug is therapeutically no worse than the standard of care therapy.

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a. Bioequivalence

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b. Inferiority

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c. N-of-1

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d. Noninferiority

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When the 95% CI for a treatment difference between a test drug and reference drug crosses the NI margin, which of the following conclusions can be made?

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a. The test drug is noninferior to the reference drug.

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b. The reference drug is noninferior to the test drug.

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c. The results are inconclusive.

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d. The test drug is inferior to the reference drug.

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Adaptive clinical trial (ACT) design provides the ability to use:

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a. Emerging data to make adjustments in the study

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b. Flexible noninterim analysis strategies

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c. Adaptive sampling designs for reallocation of patients

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d. All of the above

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After reading the following three cases, identify the study design ...

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