Stakeholders
Veterinary studies / veterinary trials routinely involve a Sponsor, Pet Owners, and at least one Site and one Investigator. In certain situations, the Sponsor may engage a veterinary clinical research organization (Veterinary CRO) to manage the study. These veterinary study stakeholders are briefly described below:
Sponsor: The Sponsor is the entity that takes responsibility for the investigational product and routinely funds the veterinary study or veterinary trial. Certain veterinary studies may be performed as investigator initiated, and therefore the investigators organization would be considered the Sponsor.
Sites: Sponsors should carefully select veterinary clinical trials sites to qualify the site and investigator(s). Selection of a trial site often takes place during a site qualification visit (SQV). The site initiation visit (SIV) can sometimes take place during the process of qualifying the site.
Investigators and Research Coordinators: Sponsors should select qualified, experienced investigators to perform veterinary clinical trials which are subject to Good Clinical Practice. Most sites will have a Principal Investigator (PI). The PI can further delegate certain responsibilities to veterinary study team personnel through a Delegation of Authority (DOA). Ultimately, the PI is responsible for all study activities that occur before, during and after the study at their respective veterinary trial site.
Site Management Organizations (SMOs) and Contract Research Organizations (CROs): These organizations are often contracted by a Sponsor to implement, manage and monitor the study, and serve as an intermediary between Sponsor and Site.
Pet Owners: Pet owners are involved in studies at veterinary clinics or academic institutions that recruit veterinary patients (non-institutional animals) from the public. Investigator’s should ensure that each pet owner consents their pet and is fully informed about the nature and risks of the veterinary trial or study’s investigational product, interventions and procedures.
Monitoring: During the course of certain veterinary clinical studies, it may be advisable to have qualified veterinary study monitors visit the veterinary trial sites to review records, source documents, and other materials which are important for the integrity of the study. Monitoring visits should occur before, during, and after a study has completed enrollment.
Overview of Veterinary Studies and Veterinary Trials
Veterinary clinical trials and veterinary clinical studies are often used interchangeably. However, our team prefers the term “STUDY” to reference as a pilot or proof of concept (POC) evaluation and reserves the term “TRIAL” for those evaluations that are intended to support a New Animal Drug Application or veterinary product license.
Veterinary Pilot Studies / Proof of Concept (POC) Studies – these are usually smaller veterinary studies intended to obtain preliminary data on safety and efficacy and are not intended to support a new animal drug application (NADA; FDA-CVM) or veterinary product license (USDA-CVB). Certain pilot veterinary clinical studies may require authorization from state or federal agencies before starting the study and sponsors should be familiar with the regulatory requirements beforehand.
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 specific animal species in which the product is intended to be administered, such as a dog, cat, horse, etc. Depending on the regulatory requirements, target animal safety studies may require dose escalation to gain a better understanding of the investigational veterinary product’s tolerance. Target animal safety studies may be performed by contract research organizations under Good Laboratory Practices (GLP), and in certain situations can be performed performed in the field setting.
Target Animal Effectiveness Studies (TAES) – Target animal effectiveness studies are those conducted in the target species to establish efficacy (effectiveness). These studies are normally conducted under Good Clinical Practice (GCP) conditions and used in support of substantial evidence. GCP should be conducted based on the the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL9)
Veterinary Study Designs & Protocols for Veterinary Clinical Studies and Veterinary Clinical Trials
Veterinary Clinical Trials should, in most cases, be reduced and performed under a well organized veterinary study protocol. Sections of the veterinary study protocol may include, but not necessarily be limited to:
PURPOSE OF THE INVESTIGATION
-Description of the Investigational Product
-Intended use of the Investigational Product
-Objectives and the clinical study (primary and secondary objectives)
Veterinary CLINICAL PROTOCOL Sections
-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.)