Answers to
questions veterinarians
ask us most often
Gain a better understanding of how you can help
pivotal studies
Here are answers to some questions you may have about participating as a study investigator or referring patients. If you have additional questions, use the Contact Form to email us, or call us at (919) 293-0243.
1. I’m interested in working as an investigator in a study. Do I need prior experience?
Prior experience with FDA-regulated studies is preferred, but not required. Each study is different, but in all cases, Sponsors provide training on their study protocols to ensure consistency and accuracy at all locations.
2. How are veterinary pivotal studies different from other veterinary clinical studies?
Pivotal studies are conducted according to FDA standards with the aim of submitting the final data to FDA for review and potential product approval. Therefore, all investigator sites have external study monitors reviewing the processes and collection of data to ensure consistency and accuracy.
3. How many investigators does each study need?
Generally, pivotal studies are multi-site studies and may have from 10 to 30 investigator sites, often located across the U.S.
4. If I participate as an investigator in a pivotal study, is it possible my practice may be visited by the FDA?
Yes, from time to time, FDA personnel may visit sites and review procedures and data collection practices at that location. This is all part of FDA’s high standards that help ensure the safety and effectiveness of animal medications.
5. How long do these veterinary pivotal studies run?
The timeline of each study is determined by the number of patients required to be enrolled; the amount of time required to find and enroll qualified patients, and how long patients participate. Generally, hundreds of patients are required to be enrolled, so studies may run for years. It is Visionaire’s goal to help identify qualified patients and speed each study to completion as quickly as possible.
6. What are the benefits of referring my patients to a participating investigator site?
There are many reasons why veterinarians would want to refer patients:
- It demonstrates your desire to help your clients and patients, and pivotal studies are often a way to offer access to novel therapies that may not be available elsewhere.
- Patient participation in pivotal studies is generally provided at no cost to owners. Covered services usually include diagnostic tests, office visits, and, of course, the investigational medication (or placebo). Frequently, there are also financial rewards for participating, as Sponsors wish to demonstrate their gratitude for the time and effort required for participation.
- You are helping to build the veterinary knowledge base about the disease or condition under evaluation in the study.
- You are potentially helping to bring new medications to market for future generations of your patients.
7. If I refer patients and they are enrolled in a study, will I continue to see these patients during their study participation?
In general, referring veterinarians will continue to see their participating patients for non-study related conditions during the study. However, we always request that referring veterinarians communicate with the study investigators to ensure investigators are aware of any potential concerns, as these decisions can vary from study to study.
8. How can I learn more about a specific pivotal study in my area?
Visionaire provides comprehensive information to referring veterinarians about each veterinary pivotal study we support. Of course, you will want to evaluate each study to determine whether you think it may be appropriate for any of your patients.