CONTRACT RESEARCH & TOXICOLOGY are not clones of one another , so there will be dramatic genetic diversity .”
In addition , the environmental factors the animals share with humans , from the climate they live in to their environmental exposures they face , play a role in introducing variability into the study but also help to get the conditions close to that of a human clinical trial . What is lost in terms of the GLP conditions of the lab study can be gained from realworld relevance .
Another important advantage to consider is the higher incidence of some rare diseases in companion animals than in humans . For instance , osteosarcoma is diagnosed in some 10,000-45,000 dogs / year in the US compared with fewer than 1,000 humans . All forms of sarcoma are commoner in dogs , which are therefore a common model for investigational sarcoma treatments . Finally , said Stallons , “ there is a great potential for the development of veterinary drugs to satisfy high levels of unmet need for some of these diseases in the companion animal population and potentially to capitalise on significant market opportunities in the veterinary space to fund dlelete human drug development too .”
Added flexibility
Other potential advantages relate to the flexibility of trial design . A veterinary clinical trial can be adapted in ways that might be more challenging in a human trial . It is often possible to recapitulate the Phase I design , for example in terms of dosing regimen , drug combinations or surrogate endpoints .
“ You may also be able to accomplish goals you could not accomplish in a human clinical trial , whether that ’ s the development of novel biomarkers or the collection of multiple timepoints or biopsies ,” Stallons said . “ These things allow significant flexibility in the veterinary trial that you could not get in the human trial .”
Veterinary trials have many similarities to human trials
In addition , it may be possible to achieve faster access to clinical trials via the veterinary route because of the different regulatory requirements . For example , Investigational New Drug ( IND ) filing is a significant time factor in human trials . In the veterinary sphere , initiating clinical trials requires minimal administrative filings with the FDA .
In 2010 , dogs with naturally occurring B-cell lymphoma were used in the safety evaluation of Imbruvia ( ibrutinib ), a monoclonal antibody for the treatment of Manta cell lymphoma and chronic lymphocytic leukaemia . More recently in 2022 , canine osteosarcoma was used as a model for CAR-T cell development . The study design matched standard human CAR-T cell trial design and the canine cytokine profile post-treatment was consistent with human data .
Other considerations
So why , Stallons asked rhetorically , is there any resistance to this approach in general ? The most important factor is probably the perception that there is a high risk of an adverse event ( AE ) in a veterinary clinical trial that will negatively impact the human trial programme .
This is a legitimate concern but should be put in context , he said . AE reporting requirements in veterinary trials are not the same as in human trials ; they vary depending on the status of the IND and the nature of the AE and it is not necessary to report every AE to the FDA immediately or indeed at all .
Another consideration is that expected AEs are included in the protocol and the informed consent provided to the animal ’ s owner , in order to prevent false attribution of safety findings for AEs that may be unrelated . The FDA evaluates data from veterinary trials in context , aware that they are conducted using animals with often very serious diseases and without concurrent controls .
“ The agency understands all this , they have evaluated all this data before and they will consider all these factors when evaluating the data for
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