This webinar on clinical study design will explore the differences among superiority, Non-inferiority (NI), and equivalence trials, including development of the precise research questions necessary to making a decision about appropriate clinical designs.
This session will explore the differences among superiority, NI, and equivalence trials, including development of precise research questions necessary to make a decision about appropriate clinical designs. The instructor will examine details of representative studies and review relevant FDA guidances.
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 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.This session will explore the differences among superiority, NI, and equivalence trials, including development of precise research questions necessary to make a decision about appropriate clinical designs. The instructor will 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 non-statisticians).
- Risk of “BioCreep” and other controversies associated with these alternative approaches.
- FDA guidance and CONSORT considerations.
Who Will Benefit:
Professionals who seek to design appropriate clinical investigations for supporting anticipated labeling for a new drug or medical device will find this course valuable. This webinar will also benefit:- Clinical Research Professionals
- Clinical Protocol Developers
- Clinical Study Managers
- Regulatory Managers
- Clinical Studies Directors
- Biostatisticians
Course Provider
Rita Hanover,
