Description
This guidance document advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness to support product approval for new animal drugs used in cats, dogs, and horses (i.e., companion animals). This guidance document is directed at clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles. In this document, CVM compares studies that use active controls to studies that use either placebo concurrent controls or untreated concurrent controls. CVM uses these comparisons to illustrate the appropriate use of an active control.
Scope & Applicability
Product Classes
3The category of products covered by this guidance.
A drug whose effect is well-defined and used as a comparator in NI trials; drug used as a comparator in a non-inferiority trial; A drug with known effectiveness used as a comparator in an NI trial.; Used in trials where a placebo is not ethical or feasible.
Inactive substance used as a comparator to establish effectiveness
Stakeholders
4Source of safety information in clinical trials
Entity submitting development data and knowledge; Entity performing the work process for change
Role of the person who may have administered the VMP
CHMP within the European Medicines Agency
Regulatory Context
Attributes
5Symbolized as Delta (Δ), defines the extent a drug can be less effective and still be non-inferior
Ability of a study to detect the study endpoint of interest
The ability to make inferences from study results to the overall target population
statistically justified calculation required in the plan
The ratio of subjects allocated to control versus drug arms, which may change over time.
Related CFR Sections (2)
- 21CFR514.117§ 514.117 Adequate and well-controlled studies.
(a) Purpose. The primary purpose of conducting adequate and well-controlled studies of a new animal drug is to distinguish the effect of the new animal drug from other influences, such as spontaneous change in the course of the disease, normal animal production performance, or biased observation. OnRead full regulation →
- 21CFR530.30§ 530.30 Extralabel drug use in nonfood animals.
(a) Because extralabel use of animal and human drugs in nonfood-producing animals does not ordinarily pose a threat to the public health, extralabel use of animal and human drugs is permitted in nonfood-producing animal practice except when the public health is threatened. In addition, the provisionRead full regulation →