NAPLEX (North American Pharmacist Licensure Examination) Practice Exam

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Ace your North American Pharmacist Licensure Examination (NAPLEX) with our comprehensive practice test. Features include interactive flashcards, multiple-choice questions, with detailed hints and explanations. Fast-track your pharmacy career today!

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Which of the following is true for a Non-inferiority trial?

  1. It aims to prove the new treatment's superiority

  2. It aims to show the new treatment is not worse than the standard

  3. It compares the effects of two unrelated treatments

  4. It disregards the safety margins

The correct answer is: It aims to show the new treatment is not worse than the standard

In a Non-inferiority trial, the main objective is to demonstrate that the new treatment is not worse than the standard treatment by a pre-specified margin. This type of trial is commonly used when proving the superiority of a new treatment might be impractical or unnecessary due to various reasons. Therefore, choice B is correct in stating that a Non-inferiority trial aims to show the new treatment is not worse than the standard. Choices A, C, and D do not accurately describe a Non-inferiority trial. Choice A is incorrect because the trial does not aim to prove the new treatment's superiority but rather its non-inferiority. Choice C is incorrect as a Non-inferiority trial typically compares the effects of a new treatment to a standard treatment, not two unrelated treatments. Lastly, choice D is incorrect because safety margins are indeed important in Non-inferiority trials to ensure that the new treatment is not significantly worse than the standard.