FDA Releases Draft Guidance for Veterinary Trials
Posted 19 June 2012 | By
The US Food and Drug Administration's Center for Veterinary Medicine (CVM) has released a draft guidance detailing best practices for setting active controls in animal studies used to demonstrate effectiveness of medicinal products in cats, dogs and horses.
As with clinical trials, FDA said the health and general welfare of study subjects should be an active consideration when determining whether to use placebo controls or active controls, which are defined as being a "known effective therapy." In cases where active controls are advisable, FDA will look for proof of the "non-inferiority" of the new treatment relative to the existing one, but other factors including the condition, disease, study design and patient population will also affect the study.
FDA notes some conditions are exhibited by a high self-cure rate, and these conditions are ill-suited for non-inferiority trials because measuring the treatment effect relative to the normal self-cure rate becomes difficult if the variable cannot be isolated. FDA recommends using placebo-controlled trials in these instances.
Active controls should be approved for the same condition and for the same species, explains FDA, with a level of effectiveness established through testing in placebo control studies. Exceptions to this rule exist, writes FDA, but only in "special circumstances."
The agency further explains tests must be sensitive enough to detect the different effects of treatment effectiveness, and recommends the use of study designs similar to those used to originally test and approve the active control drug.
Comments are due by 19 August 2012.
FDA - Guidance for Industry Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals
Draft Guidances for Industry: Active Controls in Studies to Demonstrate Effectiveness of New Animal Drug for Use in Companion Animals