Veterinary Studies (Veterinary Clinical Studies, Veterinary Clinical Trials)

veterinary studiesVeterinary clinical trials generally fall into several categories, being:

Pilot studies – veterinary studies intended to obtain preliminary data to evidence safety and/or efficacy.  Veterinary pilot studies, often termed proof of concept (POC) studies, are normally not intended for supporting a regulatory submission.

Target Animal Safety Studies (TASS) – These studies are intended to assess the safety of a veterinary drug, veterinary biologic, or other veterinary product in the target species.  Target species refers to the species in which the product is intended to be given, such as a dog, cat, horse, etc.   Depending on the regulatory requirements, target animal safety studies may require dose escalation.  Target animal safety studies may be performed by contract research organizations, and/or can be performed in the field setting.

Target Animal Efficacy Studies (TAES) – Target animal efficacy studies are those conducted in the target species to establish efficacy.  These studies are normally conducted under Good Clinical Practice (GCP) conditions and used in support of substantial evidence of efficacy.  GCP should be conducted based on the the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) VICH GL9- Good Clinical Practice (PDF – 356KB).

Veterinary Clinical Trials should, in most cases, be reduced to a protocol.  Sections of the protocol may include, but not necessarily be limited to:

veterinary clinical trialsPURPOSE OF THE INVESTIGATION

  • Description of the Investigational Product
  • Intended use of the Investigational Product
  • Objectives and the clinical study (primary and secondary objectives)

veterinary trialsCLINICAL PROTOCOL

  • Protocol Identifier, Title, Version Number and Date
  • Study Design and Schematic
  • Subject Selection
  • Anticipated Number of Subjects
  • Inclusion and Exclusion Criteria
  • Study Procedures
  • Consenting and Screening Procedures
  • Investigational Product Administration
  • Study Subject Groupings, Randomization and Blinding
  • Schedule of Study Visits
  • Procedures to Assess Safety and Efficacy, and Study Outcome Evaluations
  • Sample Size Determination and Data Analysis (statistical analysis)
  • Risk Analysis, Adverse Event Definitions and Reporting
  • Patient Withdrawal and Rescue, and Study Monitoring Procedures
  • Study Recruitment and Retention Procedures
  • Regulatory Information (IACUC, FDA-CVM, etc.)
  • Data Management and Storage, Document Retention
  • Study Contacts (Study Team Members, Delegation of Authorities, etc.)