Non-Inferiority in Veterinary Medicine - Lessons from the EU
View Presentation *Guenther Strehlau, Novartis Animal Health Keywords: Non-Inferiority, Veterinary Medicine, Active Control This talk addresses experiences with non-inferiority (NI) studies in veterinary medicine. In some situations, superiority over placebo cannot easily be demonstrated, e.g. if a placebo is not appropriate for animal welfare reasons. Non-inferiority over an active control may be an alternative. In Europe, NI trials are used relatively often and our experiences will be helpful in stimulating discussion on this topic. In particular, we will address topics such as the pros and cons of a positive control group, animal welfare considerations and speed of recruitment, how to choose an appropriate active control treatment, how to define the non-inferiority margin, do we still need a placebo group, power considerations, non-continuous endpoints (binary, survival), and non-parametric tests. Several examples, mainly from the parasite and pain area, will be used to illustrate the important points.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC