QuestionsQuestions (DA ANIMAL INDUSTRY ADMINISTRATIVE ORDER NO. 9)
It sets general scientific and regulatory/ethical guidelines for designing, conducting, controlling, and reporting clinical trials of veterinary drugs and products, especially to demonstrate efficacy and safety for authorization of new substances.
They are any substance, including biological products, applied or administered to food-producing, companion, aquatic, laboratory, and exotic animals for therapeutic, prophylactic, diagnostic purposes, or to modify physiologic functions or behaviors.
Systematic studies in target species/categories to establish therapeutic effects, including confirmation of pharmacodynamics and monitoring adverse responses; it also includes pharmacokinetic studies (absorption, distribution, excretion) in target categories to support efficacy evaluation.
Efficacy is the degree to which the manufacturer’s medicinal claims are justified and likely to be attained under practical field conditions; marketing authorization should be refused if there is lack of therapeutic effect or insufficient proof.
Responsibility lies with the registrant/sponsor, the overall supervisor, and the individual investigators, with clear definition of responsibilities before trial start.
Plan trials logically from limited near-experimental studies to larger near-marketing-type field studies, with each trial part of a coherent progression of investigation.
The Overall Supervisor must be a veterinarian with clinical competence and experience; should have access to competent toxicologists/environmental biologists/(human) medical advice. Site supervisors must have expertise in the biology and clinical handling of the specific disease/condition at their location.
Relevant chemical, pharmaceutical, experimental animal pharmacology, and toxicological data professionally evaluated for the medicinal substance; includes data from laboratory species plus target and other domestic species under experimental conditions. Also, a justified waiting (withdrawal) period before slaughter/produce collection must be clearly established.
It must be secure, clearly established, and justified by pre-clinical trials; the extent of pre-clinical trials should relate to the waiting time intended during clinical trials.
All existing research data in target species/categories; effects on other important organ systems at relevant dosages; kinetic studies of active ingredient and formulation (possibly multiple routes); dose-response/concentration-effect and safety studies; and potential interactions with concurrently administered products.
The protocol should contain general information (titles/participants/sponsor/farms), justification/objectives, schedule (with justifications including waiting periods), design (randomization, blinding, bias reduction), subject selection (inclusion/exclusion/withdrawal criteria), treatment (product identification, control group, route/dose/schedule, concomitant treatment rules, operator safety, compliance monitoring), efficacy assessment methods and timing, adverse reaction handling/reporting, operational matters (deviations, team coordination, staff instructions, confidentiality), record handling, evaluation and statistics, plus summary, supplements, and references.
To ensure that efficacy/safety findings relate to the actual product intended for marketing authorization, and to distinguish effects due to active substance versus formulation.
All suspected adverse reactions/side effects, whether serious or frequent, should be reported as quickly as possible to the competent authority, usually through the Overall Supervisor; serious adverse effects should be reported directly by the investigator/animal owner to the competent authority.
The competent authority (BAI) must be informed in writing if major deviation is contemplated.
For five (5) years or more after completion of the trial, retained in an archive until beyond the time of issue of the relevant marketing authorization.
Labelling must include words like “For Veterinary Clinical Trial Only,” the identity of the Overall Supervisor responsible or the manufacturer sponsoring the trial, an assessment of safety with waiting time prior to slaughter, and relevant warning statements relevant to safety of animal, operator, or environment.
Due regard must be taken of the product’s effects on the environment, residues in produce of treated animals, and the eventual fate of animals used for food production.