Clinical studies help determine whether a new or improved treatment, diet, or therapy is safe and effective for animals. The studies can involve a new drug, device, biological agent, or a behavioural or diet change. The products or therapies must first show promising results in a laboratory setting, before being tested in a day-to-day, clinical environment.
What’s a clinical study investigator?
Clinical study investigators are veterinarians who participate in clinical studies and are responsible for overseeing the conduct of the entire study at the study site (their practice). They investigate new and existing methods within their clinical practice to assist in the gathering of data. In the US, this data will eventually be submitted to the US Food and Drug Administration (FDA)'s Center for Veterinary Medicine (CVM) and United States Department of Agriculture (USDA). An investigator’s contributions help veterinary medicine advances in improving the diagnosis, prevention, or treatment of various diseases. For this reason, clinical study investigators play an essential role in the development of new medical therapies, to improve the health of animals around the world.
If I participate in a clinical study, what are my responsibilities?
Participation in a clinical study is rewarding, but requires time, organisation and attention to detail. Before you start a study, you and your staff will be trained by a designated Clinical Research Associate, to make sure you’re set up for success. Our team members are always available to answer any of your questions, throughout the entire study period.
Are there any risks for a pet to participate in a clinical study?
Every clinical study is examined by several independent review boards, to ensure that it’s well designed, and that risks are minimised. Pets that participate in a clinical study are also closely monitored, to reduce risk. However, on some occasions, a pet’s treatment may not be effective, or a treatment may cause side effects. A pet’s condition may not improve during the study, and may even get worse. Sometimes there are also other unforeseeable, study-related risks. We’ll always discuss these risks with you, before you make a final decision to participate in the study, so that you may share the information with participating pet owners.
How does Argenta help investigators?
Argenta is committed to delivering the highest quality data possible — and we’re there with you every step of the way — so you can feel confident about your work and contributions. We assess every potential clinical site for their suitability and commitment to run the study. We also offer full support for our clinical study investigators, including extensive training, monitoring visits, regular check-ins, and follow-ups. We can do this through in-person visits, as well as virtual meetings. Additionally, we support our investigators with patient enrollment tactics and programs.