Chapter 5: Literature Evaluation II: Beyond the Basics

Chapter 5. Literature Evaluation II: Beyond the Basics

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

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

a. Case study

b. Case report

c. N-of-1 study

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

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

a. Case report

b. Case series

c. N-of-1 study

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

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

a. Case series

b. Bioequivalence

c. Postmarketing

d. Stability

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

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

a. Bioequivalence

b. Inferiority

c. N-of-1

d. Noninferiority

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?

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

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

c. The results are inconclusive.

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

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

a. Emerging data to make adjustments in the study

b. Flexible noninterim analysis strategies

c. Adaptive sampling designs for reallocation of patients

d. All of the above

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