Sample Size for Non-inferiority Studies

In this webinar, you will learn about:

• Introduction to Non-inferiority Designs
• Important Designs Considerations for Non-inferiority Designs
• Sample Size Determination for Non-inferiority Designs
  
  Non-inferiority Sample Size Examples include:
  
• Crossover Design for Normal Endpoint
• Two Arm Tests for Binomial Endpoint
• Three Arm “Gold Standard” Trial for Survival Endpoint
• Two Arm Test for Count Model 

More about the webinar

Non-inferiority testing is used to test if a new treatment is not inferior to a standard treatment. This is a common objective in the areas such as medical devices and generic drug development. For example, if a proposed device or treatment were less invasive than the standard treatment then non-inferiority would be an appropriate route to improve patients’ treatment choices. 

To test for non-inferiority, the treatment group is tested to verify it is above the non-inferiority margin. The non-inferiority margin is a level below equality that would still be considered acceptably non-inferior to the standard treatment. The definition of the non-inferiority margin is a matter of significant debate and is an important aspect of regulatory guidance from agencies such as the FDA.

Non-inferiority studies can be conducted for a wide variety of different endpoints including continuous, binomial, survival and count endpoints. Each of these endpoints present unique design and statistical considerations with a wide range of potential design choices. For example, common designs for non-inferiority are crossover designs, three arm trials and parallel arm trials.

In this webinar, we review non-inferiority testing design considerations and demonstrate how to determine the sample size for a wide variety of endpoints and designs.