Pet products need to undergo clinical research in much the same way as the supplements we take, but often new pet brands can be unsure of how to go about this process. It’s vital to understand the clinical trial procedure, as this is how pet brands are able to evaluate the safety and effectiveness of a product, as well as to provide scientific support for claims about a formula’s performance. This process is essential for pet supplement brands to demonstrate the validity of their product claims and gain the trust of pet owners.
Overview of the Clinical Trial Process
The clinical trial process for pet supplements is similar to that of clinical trials for human supplements. The process begins with preclinical testing, which involves laboratory testing and animal studies. This is followed by clinical testing, which involves testing the product on a group of animals under controlled conditions. The final stage is post-market surveillance, which involves monitoring the product once it has been released to the market. This is generally the stage where specific product claims are made, for example:
“Clinically proven to aid in joint disease management.”
“Supports the maintenance of a shiny, healthy coat.”
Before starting the clinical trial process, pet supplement brands should strongly consider working with a Contract Research Organization (CRO). A CRO is responsible for conducting the clinical trial, managing the data, and ensuring that the trial is conducted in compliance with regulatory requirements. You can learn more about the benefits of using a digital CRO in particular, here.
The clinical trial process for pet supplements can take several months or even years to complete, depending on the complexity of the product and the size of the study. However, the investment of time and resources into clinical trials is critical for pet supplement brands to establish the safety and efficacy of their products and to gain the trust of the pet owner and veterinary communities.
Recommended Study Designs for Pet Supplement Clinical Trials
When conducting clinical trials for pet supplements, it's important to choose the right study design to ensure accurate and reliable results. Here are some recommended study designs to consider:
1. Randomized Controlled Trials (RCTs)
This is often considered the gold standard in clinical trial design, for people and pets alike. Participants are randomly assigned to the experimental group (receiving the supplement) or the control group (receiving a placebo or no treatment). This design helps to control for confounding variables and minimizes the risk of bias.
2. Parallel Design
In this design, participants are assigned to either the experimental or control group and remain in that group for the duration of the trial. This design helps to minimize the risk of contamination between the groups.
3. Crossover Design
In this design, participants are randomly assigned to either the experimental or control group for a set period of time. After a washout period, the groups are then switched, with the experimental group now receiving the placebo and vice versa. This design helps to control for individual differences in response to treatment.
4. Factorial Design
This design involves testing two or more interventions simultaneously, allowing for the evaluation of their individual effects as well as any potential interactions.
Ultimately, the choice of study design will depend on the specific research question being asked and the resources available. Working with a CRO can help pet supplement brands navigate the complexities of clinical trial design and ensure that their studies are conducted to the highest standards of quality and integrity.
Best Practices for Conducting Clinical Trials with Pets
When it comes to conducting clinical trials with pets, there are some best practices that need to be followed to ensure that the results are accurate and reliable. First and foremost, it is important to work with a reputable CRO (Contract Research Organization) that has experience in conducting clinical trials with animals. They can guide you through the process and help you design a study that will provide the results you need.
It is also important to choose the right population of animals for your study. This means selecting animals that are representative of the population you are trying to target with your pet supplement. For example, if you are targeting older dogs with joint pain, you should select animals that are of a similar age and breed to your target population.
Another best practice is to use a placebo group in your study. This is important to ensure that any observed effects are actually due to the supplement and not just a placebo effect. Randomization and blinding are also important techniques to use in clinical trials to minimize bias and ensure that the results are as objective as possible.
Finally, it is important to collect and analyze data carefully to ensure that the results are reliable and statistically significant. This means using appropriate statistical methods to analyze the data and reporting the results accurately and transparently.
By following these best practices for conducting clinical trials with pets, you can ensure that your pet supplement brand has the clinical evidence it needs to stand out in a crowded market and build trust with customers.
Mitigating Common Challenges
Working to create clinical evidence can be a challenge, especially for newer or smaller pet supplement brands that may not have experience in this area. Here are some common challenges and ways to mitigate them:
1. Budget constraints
Clinical trials can be expensive, and many pet supplement brands may not have a large budget. However, there are ways to reduce costs such as designing the study to maximize efficiency, using a virtual CRO, or partnering with other brands to share costs.
2. Recruiting participants
Finding enough participants for a study can be difficult, especially if the study is long or requires a specific demographic. Partnering with veterinary clinics or pet shelters can be a way to recruit participants, as well as offer incentives (to the parents of the pets involved) for participation.
3. Regulatory compliance
There are various regulations that must be followed when conducting clinical trials, such as obtaining ethical approval and ensuring participant safety. Working with a CRO that has experience in navigating these regulations can help ensure compliance.
4. Data management
Collecting and analyzing data can be a complex process, and errors can occur if it is not managed properly. A CRO can help with data management, ensuring that the data is accurate and reliable.
By being aware of these common challenges and taking steps to mitigate them, pet supplement brands can work with a CRO to obtain the clinical evidence needed to support their products and stand out in the market.
Regulatory Considerations for Pet Supplement Research
When conducting clinical trials for pet supplements, it is important to consider regulatory requirements. In the United States, the Federal Food, Drug, and Cosmetic Act (FD&C Act) regulates pet supplements and requires that they are safe for use and labeled truthfully and accurately. The U.S. Food and Drug Administration (FDA) oversees compliance with the FD&C Act and can take enforcement action against companies that do not comply.
To ensure compliance with regulations, it is important to work with a Contract Research Organization (CRO) that has experience in conducting pet supplement clinical trials. A CRO can help to design a study that meets regulatory requirements and can assist with obtaining necessary approvals from regulatory agencies.
It is also important to ensure that any claims made regarding the efficacy of the pet supplement are supported by clinical evidence. This evidence should be generated through well-designed clinical trials that follow appropriate protocols and are conducted in compliance with regulatory requirements. By ensuring that clinical trials are conducted in compliance with regulations, pet supplement brands can demonstrate the safety and efficacy of their products and build trust with consumers. This can ultimately lead to increased sales and a stronger brand reputation.
Want to create your own clinical trial?
Citruslabs provides a simple and affordable way to prove that your products actually work. At Citruslabs, we design a clinical trial that is right for you and your budget, so you can start sharing research-backed product claims without spending a fortune. We offer the cohesive planning and management required to conduct successful clinical trials, from start to finish. Ready to get started? Let's talk! You can contact us here.