Non-inferiority Trials: Practical Issues and Current Regulatory Perspectives

Why Should You Attend:

Basic non-inferiority (NI) clinical study designs appear to provide a straight-forward approach for evaluating whether a new drug or medical device is an appropriate substitute or replacement for a current standard treatment. In these studies the typical comparison is between a new drug and an active control with the goal of demonstrating that the new drug is “not inferior” to the standard treatment by “too large” a margin. Traditional approaches to demonstrating NI of a new drug amounted to a simple acceptance of the null hypothesis of no difference between that drug and an active control, but these are currently recognized as inadequate to support a claim of NI.

This webinar will examine the philosophy and assumptions underlying NI trials by highlighting the differences among NI, equivalence, and superiority trials with regard to basic clinical study designs and appropriate hypothesis tests, power and sample size, and conceptual and statistical analysis differences. We will conclude with a review of current FDA guidance for NI clinical studies.

Areas Covered in the Seminar:

• Description and comparison of NI, equivalence, and superiority study objectives and designs.
• Zeroing in on the specific clinical question to be asked.
• Decision tree for choosing the appropriate design to answer the specific clinical question.
• Why assay sensitivity matters and what you can do to maximize it.
• How to determine the appropriate or acceptable “margin” of inferiority.
• Appropriate hypothesis tests and statistical interpretation. (for non-statisticians).
• FDA guidance.

Who Will Benefit:

Professionals who will benefit from this webinar include:

• Clinical Research Professionals
• Clinical Protocol Developers
• Clinical Study Managers
• Regulatory Managers
• Clinical Study Directors
• Biostatisticians
• Anyone who seeks to design appropriate clinical investigations for supporting anticipated labeling for a new drug or medical device.
• Anyone who seeks to design appropriate clinical investigations that address the specific clinical development plan for a new drug or medical device while meeting the marketing goals of the company for that product.

Instructor Profile:

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. 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)

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