Phase 1 trials are typically conducted in a small group of animals (6-12) with cancer to test a new treatment that has never been tried in a clinical patient. The goals are to evaluate safety and side effects, and to determine the dose and way to use the treatment. It is important to remember that no therapeutic benefit is expected in a phase 1 trial.
Phase 2 trials use information from phase 1 trials to use the new treatment at a given dose and schedule in a larger group of animals with cancer (usually 20-40). The goal of a phase 2 trial is to determine efficacy of the new treatment and further evaluate safety. In cancer clinical trials, a phase 2 trial is intended to determine what types of cancer will respond or how well a given cancer responds to a new therapy.
Phase 3 trials compare the new treatment to standard treatment options in a large group of animals with cancer. The goal is to determine whether the new treatment is better than other common treatments and to further monitor safety and side effects.
Phase 4 trials compare two or more well-established treatment regimes in a given group of patients, typically after the treatment has already been approved for use (in people) or in common use (in animals).
Standard of care: This phrase is used to describe the treatment that is most commonly used for a certain cancer by most veterinary oncologists currently in practice. Standard of care may be determined by past clinical trials, or may be the result of opinions formed when treating animals over time. In the absence of good-quality, controlled clinical trials, or in the event that properly designed trials have not found a treatment that benefits the patient, there may not be a standard of care established by the veterinary oncology community for a given cancer.
Benefits of a clinical trial: Owners of animals with cancer, as advocates for their companions, may choose to participate in a clinical trial for a number of reasons. The knowledge gained in clinical trials benefits countless animals in the future. Additionally, interventional trials such as Phase 3 and 4 trials may allow a patient to benefit from a promising new treatment before it is widely available.
What research has been done before a clinical trial is initiated? Depending on the phase of research, various questions may have been answered. Prior to phase 1 studies, preclinical work may include research with cell culture or rodents, and new drugs have typically been given to healthy animals before they are offered to animals with cancer in order to determine expected side effects and a general idea of dose and safety.
What questions should I ask when considering a clinical trial for my pet?
Owners of animals with cancer should be well-informed prior to making a decision about clinical trial enrollment. The following are a few questions that may help owners make a decision that is right for them and their pet:
What is the purpose of this trial?
Who is eligible?
What tests must be done to determine if my pet is eligible?
What does the trial involve with regards to time commitment?
How often are visits required?
Must all treatments and monitoring be done at the UMC-VMTH?
How long will each visit take?
What will I be required to do at home?
Can I withdraw my pet from the trial at any time?
Who should I contact if I have questions or concerns during the trial?
What are the expected side effects?
What are the costs?
Why would I enroll my pet in a clinical trial?
There are many benefits to enrolling in a study. The reason new treatments are proposed is often because basic research has suggested a reason why it might be more successful than what is currently recommended. Sometimes our theories don’t prove to be true but sometimes we discover a new and exciting effective treatment for a disease. Beyond therapeutic reasons, there are often financial reasons to enroll in a study. Please be aware that you will be responsible for the costs of initial evaluation. When clinical trials are offered, we often are able to subsidize the cost of treatment. Ethically, many people enroll themselves or their pets in trials because it allows us to help not only the patient but also future patients. Research in animals can also sometimes benefit people and vice versa. It is comforting to know that despite the fact that a patient is battling cancer, whether the outcome is good or bad, some good will come of all that is done.
What should I know about being part of a clinical trial?
Your participation in a clinical trial is of great value to the veterinary oncology community. It is important to abide by all rules of the trial in order to generate results that are valid. Never give your pet any medication, even over-the-counter medication, without first consulting your clinical trials service. Always be honest about your pet’s exposure to other animals, medications, and environments before, during and after the trial. Always inform your oncology team of changes in your pet’s health, even if you do not think it is relevant. If it helps you, write things down between visits and bring this list with you to the next visit. That way your team can decide what information is relevant. Lastly, follow up is very important to be able to have complete data in a study. Please keep in touch after the study period has finished and if you move during the lifetime of a pet who participated in a study, please let your veterinary oncology team your forwarding contact information.
Without our support the veterinary oncology community would not be able to make important advances in the treatment of pets with cancer. If you have any questions, please contact the Clinical Trials Coordinator at the veterinary treatment facility.