While many early pet products may have been loosely adapted from human supplements, there is growing recognition about how different animal physiology actually is.
Ronaldo Avella Lavado, business development, operations and regulatory affairs manager at consulting firm Paul Dick and Associates, which provides services including clinical trial design and monitoring, said the drive for greater scientific research is economically driven as well. As veterinary costs continue to rise, pet owners are increasingly focused on preventative approaches that can help support their pets’ long-term health and vitality.
Part of this preventative health focus also reflects pet owners’ interest in targeted health solutions for their animals. Historically, many companion animal supplements emphasized broad health benefits, such as overall wellness and gut health. While those claims are still common, today’s pet owners are looking for science-backed products that address specific health concerns and support the unique needs of different life stages.
Some of the fastest-growing supplement categories include healthy aging, cognitive function, joint health, immune support, skin health, weight management and behavior support.
Here, Lavado discusses what is now required of studies in the space including learning from human clinical trials, the pitfalls of humanizing pets and the challenges of conducting real-world studies.
NI+: Because there is growing demand for science-backed claims, what advice do you give clients about investing in clinical trials for pets?
RAL: Although most jurisdictions do not require efficacy studies in the target species to support pet supplement claims, companies are increasingly evaluating whether investing in clinical research makes sense from a scientific and commercial perspective.
We regularly receive inquiries from clients asking whether they should invest the time and financial resources required to conduct clinical trials in companion animals. In most cases, the primary objective is not regulatory approval but rather building a strong scientific foundation for marketing and communication with both veterinarians and pet owners, besides supporting their internal R&D for novel products.
Our advice is generally to invest in generating proprietary data whenever possible. While efficacy studies may not be required before bringing a supplement to market, consumers are becoming more educated and are increasingly looking for meaningful scientific evidence to support product claims.
One area where the industry is evolving is the expectation for species-specific evidence. In the past, it was common to see companies use dog data to support products marketed for cats. Today, cat owners are becoming more informed and increasingly expect claims to be supported by data that is directly relevant to their pets. ‘Cats are not small dogs’ and we couldn’t agree more. For companies with the resources to do so, conducting parallel studies in both dogs and cats can provide a stronger scientific and commercial position.
NI+: What are the challenges of directing real world clinical trials in companion animals?
RAL: As a consultancy firm that provides both regulatory and scientific support for clinical trials, including protocol development and study monitoring, we find that one of the biggest challenges in real-world companion animal studies is ensuring compliance with the study protocol.
Unlike many human clinical trials, companion animal studies often rely heavily on pet owners to follow the protocol correctly. This includes administering the supplement according to the study plan, collecting data consistently and accurately reporting observations throughout the study period.
Depending on the study objective, owners may be asked to complete wellness questionnaires, monitor changes in mobility, record how long their dog can comfortably walk before showing signs of fatigue or discomfort, or provide photographs and other observations. The quality of the data ultimately depends on how consistently these activities are performed.
Another challenge is controlling factors that can influence the study outcome. Companion animals live in dynamic household environments, and routine changes can introduce confounding factors that affect the results. For example, in a study evaluating behavior or calming support, the introduction of a new family member, a new pet, frequent visitors, changes in daily routines or other environmental stressors can influence the outcomes independently of the supplement being tested. Similarly, changes in diet, feeding schedules, treats or the addition of other supplements can impact study results across a wide range of health indications.
This is why close monitoring is so important. Regular follow-up with participants, oftentimes on a daily or weekly basis, helps ensure compliance with the protocol, allows researchers to identify potential confounding factors early and ultimately improves the quality and reliability of the data generated.
NI+: What are the issues with applying human data to companion animals?
RAL: From a regulatory standpoint, target species data is often necessary to establish safety, particularly for novel ingredients. While requirements vary across jurisdictions, regulatory authorities generally expect a certain level of safety information generated in the species for which the product is intended.
From a scientific perspective, the growing humanization of pets can sometimes create the misconception that data can be directly translated across species.
However, pets are not small humans. Each species has important physiological and metabolic differences that can influence how an ingredient is digested, absorbed, utilized and tolerated. This is mainly true for biotics, probiotics in particular, as each species has different microbiomes. These differences can also affect the inclusion levels needed to achieve a desired benefit, as well as the types of health claims that are scientifically appropriate for each species. In some cases, ingredients that are well tolerated in one species may not be tolerated in another, which further highlights the importance of species-specific research.
For many companies, human data can serve as a valuable starting point and help establish the rationale for product development. However, in the long term, companies should be prepared to generate and provide target species data if they want to build credibility, differentiate their products and meet evolving market expectations.
NI+: How do human clinical trials and companion animal trials intersect?
Ronaldo Avella Lavado: It’s quite common for human-focused companies to conduct studies in companion animals during product development. In some cases, companion animals can provide an efficient and cost-effective way to generate early proof-of-concept data before moving into larger human clinical trials.
Because of this, many companies end up generating valuable data in companion animals and later recognize the opportunity to use that research as the foundation for a pet health supplement line. It’s not unusual to see promising results from an initial companion animal study lead to a more targeted clinical trial designed specifically to support regulatory, scientific and marketing objectives in the target species.
The exchange of knowledge also works in the opposite direction. Companies that have experience running human clinical trials often apply those learnings when designing studies for companion animals. They can build on previous experience, refine study protocols, and avoid challenges they may have encountered in earlier human research. This can help create more efficient and effective companion animal studies.
NI+: What do you see on the horizon for supplement research in this field?
RAL: One of the biggest trends we expect to see is a continued shift toward clinical studies conducted in real-world settings with client-owned pets rather than exclusively in laboratory animals. Laboratory studies will continue to play an important role in generating foundational data, but companies increasingly recognize that research conducted under real-life conditions often provides more meaningful evidence to support product claims and better reflects how supplements are actually used.
These studies can be more challenging to conduct because they rely heavily on owner compliance, consistent data collection and the management of variables that are difficult to control in a home environment. However, despite these challenges, we expect real-world evidence to become increasingly important in companion animal research as the pet owners see these results with other eyes.
Another trend is a growing focus on outcomes that are meaningful to pet owners themselves. Biomarkers and clinically defined endpoints will always remain important, but when developing supplements, it is equally important to understand how owners perceive changes in their pets’ health and quality of life following supplementation. As a result, we are developing more studies incorporating owner-reported outcomes. These may include perceived activity levels, overall well-being, happiness, mobility, stress levels or other observations that reflect the pet’s daily quality of life. In some cases, researchers are even evaluating outcomes related to the owner’s experience, such as whether walks are more enjoyable or whether interactions with their pet have improved.
Ultimately, pet owners are the ones making purchasing decisions, so understanding and measuring the benefits that matter most to them is becoming increasingly relevant. We also see regulators becoming more open to claims supported by these types of owner-centered outcomes, provided the studies are well designed and the data is collected in a robust manner.
