In exchange for your time and feedback while your dog, cat, or horse is participating in a pivotal study, most pharmaceutical study sponsors cover the cost of everything required for the study. That coverage may include:
- Veterinary exams to determine whether your pet qualifies for enrollment, and if so, then on-going evaluations from veterinarians and staff who have received specialized training to help conduct the study
- Diagnostic tests such as urinalysis, bloodwork, radiographs (X-rays), and in some cases, even CT scans and MRIs
- Investigational (or test) medication or placebo.The medication being evaluated may be an oral, injectable, or topical formula. Most pivotal studies also use a placebo treatment, which generally looks identical to the investigational medication, but contains no medication. Placebo treatments are required to ensure that any observed effect from the investigational medication is valid, and not due to chance.
There is a scientific path leading to new FDA-approved medications for pets
Evaluation of pet medications for potential FDA-approval follows a series of veterinary clinical studies, each intended to answer specific questions about the new medication. Pilot studies are the first step, and answer the question, “Does this new idea have potential as a new medication with clear benefits to pets?” Multiple pilot studies may be conducted to work out the dose and the conditions of use before the new medication is ready for pivotal studies.
A pivotal study is the final study conducted before a potential new pet medication is submitted to the FDA for possible approval. These studies are called “pivotal” because they will inform the FDA’s final decision.
Depending on the study, the total value of the diagnostics, care, and medication your pet receives may range from hundreds to thousands of dollars.
There are other reasons to consider a pivotal study for your pet. These include:
- Access to new medications/treatments
You may choose to enroll your dog, cat, or horse in a pivotal study because your pet is struggling with a disease or condition, and no solution currently available has been able to treat it effectively. In these situations, an investigational medication may help your pet when other approved medications have failed. Since it can take many years of research and studies to achieve FDA approval — and bring the veterinary medication to market — participation in a clinical trial provides access to a new pet medication before it is publicly available. - Access to treatments that are prohibitively expensive
Sometimes, enrolling your pet in a pivotal study can provide treatments you may not otherwise be able to afford. - Helping advance veterinary medicine’s understanding of your pet’s condition
When you and your pet participate in a pivotal study, you are not only helping veterinarians understand the investigational medication; you are also helping better understand the condition that affects your pet. - Potentially help pets and pet owners in the future
If the medication evaluated in the study is ultimately approved by FDA, then your pet’s participation could help millions of pets in the future. This is a key reason many pet owners report as why they participate in studies.
What pet owners will need to do while participating in a pivotal study
While it is true that most veterinary pivotal clinical studies are free to pet owners, they do require an investment of your time and attention. Here are some considerations that may affect your decision:
a) You will need to make visits to the study veterinarian’s practice
If your pet qualifies for enrollment, you will be expected to bring your pet in to be monitored at specified time points, or in some cases, be available to discuss how your pet is doing by telephone. Each study has varying lengths of participation, ranging from days to months. Before enrolling your pet in a study, you should review all the requirements carefully and ensure that your schedule is flexible enough to accommodate the commitment.
b) You may need to document the test medication’s effects
As an owner of a pet enrolled in a pivotal clinical study, you may be required to administer medication to your pet. Also, you’ll need to document when you give the medication and note your pet’s progress in a logbook which may be online or on paper.
c) You may have to forgo certain other current treatments for your pet
While your pet is enrolled in a study, you may be limited as to what other medication you can give your pet. You will probably not be allowed to administer any existing treatments for your pet’s condition, as the purpose of the study is to evaluate how your pet responds to the investigational medication. This will be clearly explained to you prior to your pet’s participation.
There are risks in a pivotal study
All medications have potential risks and benefits. More is typically known about the risks of medications in pivotal studies than other types of studies. This is because the medications tested in pivotal studies have already been evaluated in several prior studies. By the time a test medication is ready to be administered to pets in the real-world or “field” situations that are required for a pivotal study, researchers have already gained a strong understanding of the medication’s potential benefits and most common adverse effects.
It is also important to understand that the test medication may not have any effect on your pet, either because it does not perform as expected, or because your pet received a placebo treatment. And while the test medication may help your pet, it may not be available for years after your pet’s study participation is over, which can be frustrating, especially if your pet responded well to it.
How do I enroll my pet in a pivotal study?
If you are interested in enrolling your pet in a veterinary pivotal clinical study, your next step is to find a study for which your pet qualifies. Every pivotal study has certain requirements, which usually concern the pet’s age, health, and current condition. Some studies also take the pet’s temperament into consideration too. For example, a pet that does not enjoy a yearly veterinary exam will probably not enjoy multiple exams.
Keep in mind that although you may wish to enroll your pet in a study, there is a screening process that the participating veterinary clinic must conduct to determine whether your pet qualifies. Once you have found a study in your area, the process usually begins with several basic questions regarding your pet. If your pet qualifies, you may be asked to bring your pet in for a free screening exam that will confirm your pet’s current condition and ensure that there are no other undiagnosed health issues. If your pet passes these preliminary steps, you will be invited to enroll your pet in the study. You will be given more details about the study and its requirements, as well as a consent form to sign.
Enrolling your pet in a pivotal study can be a way to receive no-cost care from a well-qualified veterinarian. If you are considering this option for any of the studies that Visionaire supports, we would be happy to help you explore it further. Please feel free to contact us.
FAQs about pivotal studies
Even though pivotal studies have long played a critical role in the veterinary pharmaceutical industry, there is surprisingly little information available about them. Here are answers to some commonly asked questions from pet owners.
1) Are pivotal clinical studies legitimate?
Yes. Veterinary pivotal clinical studies are the final studies sponsored by sponsoring companies before a potential new pet medication is submitted to FDA in the hope of gaining approval. Such studies offer a legitimate way to gain quality veterinary care for your pet, generally at no cost. The procedures for conducting the studies are outlined by FDA, and each study site receives specialized training and regular monitoring to ensure the study is conducted according to strict protocols.
2) How do I know if a clinical study is a pivotal study?
Pivotal studies can be difficult to identify, especially as they are rarely called that. Pivotal studies may have 25 or more veterinary practices helping to conduct the study across the U.S. The key defining feature of a pivotal study is that the summary data will be used to submit an application to FDA for potential approval of the investigational medication. The veterinarian in charge of the study site in your area can tell you if this is the goal of the study.
3) Who pays for medications in pivotal studies?
If your pet qualifies to participate in a pivotal study, the investigational medication (or placebo) will be provided to your pet at no charge. The study itself is paid for by the study’s sponsor, which is usually a pharmaceutical company.
4) Do pivotal studies pay for travel?
Every pivotal study differs in what it will reimburse. While it is uncommon for studies to pay for travel, if your pet suffers from a very rare disorder or condition, the sponsor may cover you and your pet’s travel and lodging.
5) Where are veterinary pivotal studies conducted?
Pivotal studies may be conducted in general veterinary practices, specialty veterinary practices, veterinary referral hospitals, and/or colleges of veterinary medicine. In all cases, one or more trained veterinarians will be in charge of the study at that location.
6) How long do veterinary pivotal studies last?
The length of time a pet participates in a veterinary pivotal study will depend on the treatment being investigated. Generally speaking, pet medications that are administered frequently for chronic, on-going conditions are studied for months or longer. Medications used for acute or critical situations are evaluated over a shorter time period.
7) Can I exit a pivotal study before it is complete?
Enrollment in a study is totally voluntary. While it is hoped that you keep your pet enrolled for the study duration, you may withdraw your pet at any time, for any reason. To better understand your experience and to help improve future studies, the study sponsor may ask the reason an owner withdraws, but providing the answer is also voluntary.
8) Is there an FDA for pets?
There is only one FDA (Food and Drug Administration), which is responsible for approving all medications, foods, biological products, and cosmetics sold in the U.S. for both people and animals. However, there is a branch of the FDA responsible for ensuring that animal medications are safe and effective. It is called the Center for Veterinary Medicine (FDA-CVM).
9) Are all pet medications reviewed by FDA?
Systemic animal medications — those that enter the animal’s bloodstream — are regulated by the FDA. These medications may be oral, injectable, or topical. Animal vaccines are regulated by the U.S. Department of Agriculture (USDA). Certain topical, non-systemic pet products (such as flea and tick treatments) are regulated by the U. S. Environmental Protection Agency (EPA). We invite you to learn more about the FDA and its role in approving animal pharmaceuticals.
About Visionaire Research & Education
For over 20 years, Visionaire Research & Education has helped veterinary medication sponsors bring new treatments to market. Our number one priority is helping dogs, cats, and horses — and their owners — experience a better quality of life through innovative treatments and solutions. The pivotal studies that we support can be a great way to gain access to quality diagnostics and veterinary care — and investigational therapies that often aren’t available anywhere else — all at no cost. If you have questions about the work we do, please feel free to contact us.