Use of Non-inferiority Studies in Veterinary Medicine from a Clinical Perspective
View Presentation *Lisa M Troutman, FDA/CVM Keywords: Veterinary medicine, non-inferiority, active control This talk discusses from a clinical perspective, general considerations for the use of non-inferiority studies used to establish the effectiveness of a new animal drug in veterinary medicine. The talk will focus on regulatory and clinical study design concerns. Each type of control group used in a clinical trial including placebo control, active control and historical control, has unique considerations. From a clinical perspective, considerations for the use of an active control are animal welfare concerns, study recruitment, bias, choice of the active control, constancy assumption, bio-creep, assay sensitivity, sample size, and how changes in standard of care need to be taken into consideration. The draft guidance "Active Controls in Studies to Demonstrate the Effectiveness of a New Drug for Use in Companion Animals" will be discussed from a clinical perspective.
|
Key Dates
-
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