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 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

Instructor Profile:

Dr. Rita 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, she taught research methods, biostatistics, and evidence-based medicine at the University of Utah School of Medicine, and also served as a consultant to the Utah State Department of Health, and as a director of clinical research for Techniscan Medical Systems. She has concurrently held consulting positions for such companies as Pherin Pharmaceuticals, Utah Cancer Specialists, Montgomery-Watson Environmental Engineering, and Planned Parenthood Federation of America. She earned a Regulatory Affairs Certification (RAC) in 2006 through RAPS, and is also a member of the Society of Clinical Research Associates (SOCRA), and the American Statistical Association (AMSTAT).

Topic Background:

This webinar is directed toward professionals in two broad groups. For those on the side of new drug/device developments that may have safety, ease of administration or advantages over current treatment, this discussion will explain nontraditional clinical trial designs necessary for indication designation and labeling. For those who need to intelligently evaluate clinical study design and outcome for business, regulatory, or evidence-based medical decisions, this is a discussion about how to determine the adequacy and merit of a particular study.

The pharmaceutical and medical device industry increasingly faces the challenge of launching ever more safe and efficient drugs and devices on the market. This often means looking for drugs at least as efficacious, but with some treatment advantage, over those already available, or devices that are less expensive or easier to operate.

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