19/02/2020
Learn About Veterinary Clinical Studies
Veterinary clinical studies aim to improve our scientific knowledge and to find the best ways to prevent, diagnose, or treat diseases and other conditions that can affect your animal. Choosing to participate in a clinical study is an important decision. Review the information below and talk with your veterinarian about deciding to join a study. You can find contact information for any study in the listing of a study that is actively recruiting animals for enrollment. If you find a study you are interested in, the next step is for you or your veterinarian to contact the person identified for that study and ask questions to determine both whether your animal is qualified for that study and whether the study is suitable for your needs.
CCOENTS
• What Is a Veterinary Clinical Study?Clinical Trials
Observational Studies
• Who Conducts Clinical Studies?
• Where Are Clinical Studies Conducted?
• How Long Do Clinical Studies Last?
• Reasons for Conducting Clinical Studies
• Enrolling an Animal in a Veterinary Clinical StudyWhat Animals Can Participate in a Veterinary Clinical Study?
How Are Animals Enrolled in Clinical Studies Protected?
Follow-Up Veterinary Care
Considerations for Enrolling an Animal in a Clinical Study
Another resource that you might also find helpful is our Glossary of Terms Related to Clinical Studies
What Is a Veterinary Clinical Study?
Just like a clinical study in people, a veterinary clinical study involves research that gains information from animal patients. Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. The AVMA Animal Health Studies Database (AAHSD) includes both interventional and observational studies, as well as including epidemiologic surveys.
Clinical Trials
In a clinical trial, veterinary patients may receive specific interventions according to a research plan or protocol created by the investigators. These interventions may be pharmaceutical products (drugs), or they may be procedures. Clinical trials may compare a new therapeutic approach to a standard one that is already available; to a placebo that contains no active ingredients; or to no intervention. Some clinical trials compare interventions that are already available to each other. For example, a clinical trial might compare 2 different surgical procedures for the treatment of cranial cruciate ligament ruptures, or might compare 2 different chemotherapy drugs for a certain type of cancer. When a new product or procedure is being studied, it is not usually known whether it will be helpful, harmful, or not different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the animals enrolled in the study. For example, investigators may give a drug or treatment to dogs with a cancer to see whether the tumor shrinks in size.
Clinical trials may also involve investigation of new diagnostic tests, so veterinary patients enrolled in these may be given standard care for their condition, but results from new or different diagnostic tests being investigated in the study could be informative to management of their case.
So, it should be apparent that a direct benefit to your animal is possible but is not guaranteed by enrollment in a study. However, the information gained by conducting the study should benefit future animals with the same condition.
Observational Studies
In an observational study, investigators assess health outcomes in groups of animals according to a research plan or protocol. Animals may receive interventions (which can include therapies such as drugs or devices or procedures) as part of their routine medical care, but the animals enrolled are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older dogs to learn more about the effects that being spayed previously had on the incidence of mammary cancers. Some studies simply want samples from animals with a certain condition to use to gain more basic knowledge about that disease process, or even samples from healthy animals or certain breeds of animals to use as normal controls or to use for genetic or DNA analyses.
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Who Conducts Veterinary Clinical Studies?
A clinical study is led by someone referred to as the 'principal investigator', who is usually a veterinarian. Clinical study personnel may include other veterinarians, as well as veterinary technicians. In some studies, there may be several people behind the scenes performing important roles, including basic scientists such as molecular biologists who may be analyzing samples obtained from the patients, and statisticians who assist with interpreting the data.
Clinical studies can be sponsored or funded by pharmaceutical companies; institutions such as veterinary medical colleges or universities; private funding organizations; as well as Federal agencies such as the National Institutes of Health or the U.S. Department of Agriculture.
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Where Are Veterinary Clinical Studies Conducted?
Clinical studies can take place in many locations, including colleges of veterinary medicine, veterinary practices, and veterinary specialty hospitals. The location depends on who is conducting the study. Some studies can be conducted partially, or entirely, at your veterinarian's office.
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How Long Do Veterinary Clinical Studies Last?
The length of a clinical study varies depending on what is being studied. Participants are told how long the study will last before enrolling.
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Reasons for Conducting Veterinary Clinical Studies
In general, veterinary clinical studies are designed to advance knowledge related to the treatment, diagnosis, and prevention of diseases or conditions in animals. Some common reasons for conducting clinical studies include:
• Evaluating therapeutic interventions (for example, drugs, surgical procedures, or other treatments such as radiation therapy) for treating a disease, or condition
• Finding ways to prevent the development of a disease or condition. These can include medicines, vaccines, or nutritional supplements or special diets, among other approaches.
• Evaluating diagnostic interventions for identifying or diagnosing a particular disease or condition
• Examining methods to identify a condition, or risk factors such as environmental or genetic variances that may make an animal more likely to develop that condition
• Advancing human medical knowledge in addition to veterinary medical knowledge. Many conditions in animals, such as obesity, diabetes, and many cancer types, are similar or identical to those same conditions in people. Results from well-conducted studies in animals can contribute to improvements in the care of both animals and people in those instances.
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Enrolling an Animal in a Veterinary Clinical Study
A veterinary clinical study is conducted according to a research plan known as the study protocol. The study protocol is designed to answer specific research questions and to safeguard the welfare of the animal participants. It contains the following information:
• The reason for conducting the study
• What animals may participate in the study (the eligibility criteria)
• The number of animals needed to complete the study
• The schedule of tests, procedures, or drugs and their dosages
• The length of the study
• What information will be gathered to answer the reason for conducting the study
• The potential benefits, and risks, associated with enrolling in the study
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What Animals Can Participate in a Clinical Study?
Clinical studies have criteria outlining what animals can participate that are listed in the protocol as inclusion criteria and exclusion criteria. Some research studies seek animals which have specific illnesses or conditions that will be studied while other studies are looking for healthy animals, and some studies are limited to a predetermined group of animals (such as a specific breed) which are asked by researchers to enroll.
Eligibility. The factors that qualify an animal to participate in a clinical study are called inclusion criteria, and the factors that disqualify an animal from participating are called exclusion criteria. These are based on things such as age, gender, the type and stage of a disease, previous treatment history, and any other medical conditions that the animal may have.
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How Are Animals Enrolled in Clinical Studies Protected?
Most clinical studies are conducted to try and find new and/or better ways to treat a condition, and there is no way to know that that treatment is better than existing treatments until the study has finished and the results are determined. Further, even if the treatment under investigation is better, there will likely be some animals for which no treatment is going to help. Some of the studies listed on this database are not for the purpose of investigating a new therapy, but rather to improved understanding of the disease process or to determine new methods to diagnose the condition. These studies may not offer health benefits to the animals participating but instead may benefit future animals with the same condition by improving the knowledge of that condition. To help you decide whether you would like to enroll your animal in a study, investigators will provide you with information about the study and the treatment being investigated, including information pertaining to known or potential risks or benefits. This informed consent process is intended to protect owners and animals and should provide enough information for an owner to understand the risks of, potential benefits of, and alternatives to enrolling their animal in the study. In addition to the informed consent document, the process may involve recruitment materials, verbal instructions, question-and-answer sessions, and activities to measure participant understanding. In general, a person must sign an informed consent document enrolling their animal in a study to show that he or she was given information on risks, potential benefits, and alternatives, and that he or she understands it. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over. See the Questions to Ask section on this page for examples of questions to ask the study personnel regarding participating in a clinical study.
Institutional Animal Care and Use Committees (IACUC's). In the United States and Canada, research protocols are reviewed by an IACUC (or a Veterinary Clinical Studies Committee tied to the IACUC) to determine whether the study involves any activity, such as the administration of an experimental drug or collection of samples, that would not be performed for the animal’s condition if the animal were not enrolled in the study. Studies that do not vary the care of the animal from that which would normally be done for the animals’ condition do not require further oversight. Studies which involve an activity that would not normally be done for the condition of the animal if it were not enrolled in the study, such as the administration of an experimental drug or collection of samples not normally required, are placed under continued oversight of the IACUC. IACUC oversight does not supplant the decisions for clinical care of your animal by the attending veterinarians, but does ensure that the research protocol that was described to you during the informed consent process is being followed.
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Follow-up Veterinary Care
In some instances, your animal will be required to stay at, or return to, the site conducting the clinical study for continued care or follow-up. In other instances, your animal might be returned to the oversight of your usual veterinarian.
Typically animals can continue to see their usual veterinarians while enrolled in a clinical study. While most clinical studies provide medical products or interventions related to the illness or condition being studied, they do not include care for other conditions unrelated to the clinical study. Having your veterinarian work with the clinical study personnel can ensure that the study protocol will not conflict with other medications or treatments being received.
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Considerations for Enrolling an Animal in a Clinical Study
Enrolling your animal in a clinical study contributes to understanding of diseases that affect animals and to discovering improved methods of diagnosing and treating those diseases. The results of clinical studies can make a difference in the care of future animals by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions. Further, because many diseases and conditions in animals are similar to those in people, understanding gleaned from veterinary clinical studies can serve to inform the human medical community as well!
Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at the time of the trial. Some studies may provide enrolled animals with the prospect of receiving direct medical benefits, while others may not. Some studies involve some risk of harm or injury to the animal, although it may not be greater than the risks that would normally be related to routine medical care or disease progression. Studies are designed so that the risks of participation have been minimized as much as possible and are reasonable in relation to anticipated benefits. Many studies require participating animals to undergo additional procedures, tests, and assessments based on the study protocol. These will be described in the informed consent document for a particular study. Individuals should also discuss these issues with members of the clinical study team and with his or her usual veterinarian.
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Questions to Ask
Individuals interested in enrolling their animal in a clinical study should know as much as possible about the study and feel comfortable asking the clinical study personnel questions about the study, the related procedures, and any expenses. The following questions might be helpful during such a discussion. Answers to some of these questions are provided in the informed consent document. Many of these questions are specific to clinical trials, but some also apply to observational studies.
• What is being studied?
• Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
• What are the possible interventions that my animal might receive during the trial?
• How will investigators determine which interventions my animal might receive?
• Who will know which intervention my animal receives during the trial? Will I know? Will my veterinarian know? Will members of the research team know?
• How do the possible risks, side effects, and benefits of this trial compare with those of other treatments currently available for my animals' condition?
• What will I have to do?
• What tests and procedures are involved?
• How often will my animal have to visit the hospital or clinic?
• Will my animal have to stay in the hospital?
• How long will the study last?
• Will I be reimbursed for expenses and, if so, by whom?
• What type of long-term follow-up care is required for this study?
• If my animal benefits from the intervention, will he/she be allowed to continue receiving it after the trial ends?
• Will results of the study be provided to me?
• Who will oversee my animals' care while participating in the trial?
• What are my options if my animal's condition does not improve, or worsens, during the study?
https://ebusiness.avma.org/aahsd/more_info/veterinary_clinical_studies.aspx
Veterinary clinical studies aim to improve our scientific knowledge and to find the best ways to prevent, diagnose, or treat diseases and other conditions that can affect your animal. Choosing to participate in a clinical study is an important decision. Review the information below and talk with you...
