Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

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What is the aim of a non-inferiority study in the context of RCTs?

To show the new treatment is better than standard treatment
To show the new treatment is not worse than an existing treatment
To assess the reaction to varying doses
To compare safety across treatments

The correct answer is: To show the new treatment is not worse than an existing treatment

The aim of a non-inferiority study in the context of randomized controlled trials (RCTs) is to demonstrate that a new treatment is not worse than an existing or standard treatment by more than a specified margin. This type of study is particularly useful when the new treatment may have benefits such as lower cost, fewer side effects, or easier administration, but the researchers want to ensure that it is still at least as effective as the current standard. Non-inferiority trials are designed with a specific non-inferiority margin that defines how much worse the new treatment can be compared to the standard treatment and still be considered acceptable. If the new treatment falls within this margin, it can be concluded that it is not clinically worse than the existing treatment, providing a basis for its use in clinical practice. Given the options provided, the other choices do not accurately reflect the purpose of a non-inferiority study. Demonstrating that a new treatment is better than the standard is the goal of superiority studies. Assessing reactions to varying doses relates to dose-response studies rather than non-inferiority. Comparing safety across treatments can be part of any clinical trial comparison but isn't the specific aim of non-inferiority studies, which focus more on effectiveness.