Superiority, Non-inferiority, or Equivalence Trials: How, Why and When

Why Should You Attend:

Randomized Control Trials (RCT) aimed at showing superiority remain the gold standard in clinical trial research, but are not appropriate for trials in which the aim is to show that a new treatment is equivalent or at least non-inferior to the current standard of care. The design of non-inferiority (NI) and equivalence trials is not as straightforward as that of the RCT superiority trial, and requires precise definitions of the interval of equivalence and/or region of non-inferiority.

In this session, we will explore the differences among superiority, NI, and equivalence trials, including development of the precise research questions necessary to making a decision about appropriate clinical designs. You will learn how to determine the appropriate interval of equivalence or acceptable “margin” of inferiority and also design appropriate hypothesis tests and their statistical interpretation. We will discuss how bio-creep can occur in NI trials and how you can avoid it. We will also examine details of representative studies and review relevant FDA guidances.

Areas Covered in the Webinar:

• Overview and comparison of NI, equivalence, and superiority study objectives and designs.
• Zeroing in on the specific clinical question to be asked.
• Choosing the appropriate design to answer the specific clinical question.
• How to determine the appropriate interval of equivalence or acceptable “margin” of inferiority.
• Appropriate hypothesis tests and statistical interpretation. (for nonstatisticians)
• Risk of “BioCreep” and other controversies associated with these alternative approaches.
• FDA guidance and CONSORT considerations.

Rita Hanover 

Dr. Hanover, has worked in clinical research for over 30 years, as a Principal Investigator for studies funded by national agencies such as NIMH, Veteran’s Affairs, and DOD as well as various private pharmaceutical and medical device companies, as a Professor teaching research methods, biostatistics, and evidence-based medicine at the University of Utah School of Medicine, a Consultant to the Utah State Department of Health, and Director of Clinical Research for Techniscan Medical Systems.