Where’s The Research? Helping our Animals

Animals and people are diagnosed with many of the same illnesses. There are certain types of animals found to be most credible in certain research studies than others. The information gained from research with animals is immeasurable; and, benefits our pets, us, and other animals around the world.

Preclinical and clinical studies are conducted to determine if a hypothesis or drug/procedure/remedy in question is viable. Preclinical studies, also known as the ‘study before the study,’ are often conducted on animals. Once a sufficient amount of research has been collected, the study may move to a clinical research project involving people who have voluntarily enrolled.

Preclinical Studies

According to the Handbook of Experimental Pharmacology, preclinical research can be broken down into hypothesis generating (exploratory) and hypothesis testing (confirmatory) research.

Hypothesis generating studies are often curiosity and/or intuition-driven with science-based theories regarding the pathophysiology of a disease. This is where the preclinical trial starts; it’s essentially ground zero. Hypothesis testing studies are when the actual preclinical study, often involving animals, begins. 

Preclinical trials are experiments or tests conducted prior to an official clinical trial or human involvement. There are two types of preclinical trials that may be conducted: in-vivo and in-vitro.

In-vitro

In vitro trials are often conducted in laboratories on living cells, but not on living humans or animals whereas In Vivo trials are often conducted on animals in a research setting.

These types of trials are generally conducted utilizing test tubes and plastic culture dishes. The cells are derived from humans or animals, but do not have a direct impact on the human body or the animal body. The drawback to this type of study is scientists are not able to determine a result based on the body as a whole, but they are still able to gain a basic understanding of the subject being studied. The results of in-vitro experiments help scientists properly design experiments to continue their research.

In Vivo

Researchers who are beginning the hypothesis testing phase in vivo must develop clear protocols for the study. The plan to analyze statistics associated with the study must be carefully laid out, including any bias that may influence the study, prior to beginning. The protocols involved in an in vivo study must be pre registered and published to reduce the impact of bias. Bias can result in a study becoming null and void and/or unethical to the test subject. Publishing prior to beginning the in vivo study allows other researchers to contribute their opinion and/or experience to result in a more well-rounded research study. 

Generally, preclinical trials are small, but provide in-depth information regarding the subject matter. According to the Food and Drug Administration, in the pharmaceutical test industry, “ these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their findings and decide whether the drug should be tested in people.”

The principles and guidelines for publishing a preclinical trial, as endorsed by the National Institutes of Health to qualify studies for publishing, include:

• • Rigorous statistical analysis: this should be incorporated into the section for authors for scientists to check the study for statistical accuracy
  • Full transparency: though studies must be precise and to-the-point, there is no limit on the methods section of the study where scientists are able to explain what they did and why they utilized a certain method as opposed to another. This must be made available to both readers and reviewers. 
  • Sharing of data and materials: all data must be available upon request when ethically appropriate.
  • Acceptance of refutations: researchers must accept their study may be rebutted by other scientific studies using the same or different methods
  • Report sources: all sources must be reported. For example, if living cells were obtained, where did the living cells come from?
  • Endorsements: the study may be endorsed by a research organization, publication, or other agency within the scientific community.
• All guidelines applicable to the research being conducted must be followed to make the study viable.

Clinical Trials

Clinical trials often examine the effects of a drug, compound, or surgical protocol, medical device, or other subject matter on human health. In a clinical trial, people volunteer to become a part of the experimental drug or procedure usually due to it being the best option, or only option left, for their particular circumstance. Clinical trials must be carefully planned, supervised, written, and concluded with specific results made available to the research community.

According to the World Health Organization, there are four phases of a clinical trial:

• Phase One: Tests new drugs using a small sample size (small number of people) to determine a safe dosage range and evaluate side effects
• Phase Two: Another round of people are tested, this time with a larger sample size, to further determine adverse effects.
• Phase Three: In phase 3, studies are conducted with large sample sizes in different populations (ex. Different parts of the country or in different countries). This is the phase prior to approval or denial of a new pharmaceutical, protocol, etc. in the medical community.
• Phase Four: This phase takes all the prior phases into consideration and begins providing the subject matter over a longer period of time (or denying access due to research findings).

Why Use Animals

We, as humans, are animals. As such, animals like mice provide us with an in-depth, detailed view into how humans may interact. Mice, for example, share 98% of our DNA. Animals are also diagnosed with many of the same health conditions we are including cancer, diabetes, and cardiovascular disease. 

There are many people who question the efficacy and ethical standards of using animals in research settings. With guidelines in practice, ethical standards for animal testing are set extremely high, and must be adhered to for research to be published. Animals are incredibly helpful in research and must be provided optimal care.

According to Stanford Medicine, “it is important to stress that 95% of all animals necessary for biomedical research in the United States are rodents – rats and mice especially bred for laboratory use – and that animals are only one part of the larger process of biomedical research.” The same article continued to state “Stanford researchers are obligated to ensure the well-being of animals in their care, in strict adherence to the highest standards, and in accordance with federal and state laws, regulatory guidelines, and humane principles. They are also obligated to continuously update their animal-care practices based on the newest information and findings in the fields of laboratory animal care and husbandry.  Researchers requesting use of animal models at Stanford must have their research proposals reviewed by a federally mandated committee that includes two independent community members.  It is only with this committee’s approval that research can begin. We at Stanford are dedicated to refining, reducing, and replacing animals in research whenever possible, and to using alternative methods (cell and tissue cultures, computer simulations, etc.) instead of or before animal studies are ever conducted.”

Veterinarians with specialized training in laboratory settings are a critical component of an animal-based research study. Veterinarians are responsible for ensuring the ethical treatment of animals during the research. They are also responsible for providing any necessary medical and surgical support on a 24-hour, around-the-clock basis.

How Medical Research Has Helped Animals

There is a significant amount of controversy regarding the amount of research conducted on animals. We don’t have an exact number available, but research involving animals has paved the way for miraculous discoveries. For example, research on animals has helped scientists in the following ways:

• Dogs helped scientists discover insulin

• Monkeys helped develop the polio vaccine

• Mice helped develop the rabies vaccine

• Pigs helped develop skin grafts and CAT scans

• Rabbits aided in the development of corneal implants

• Rats helped discover how to best screen for carcinogens

In the animal world, research on viruses developed the parvovirus vaccine for dogs. Research regarding reproduction aided in the development of breeding programs for endangered species. HIV/AIDS research helped determine how to best help cats prevent FIV/Feline Leukemia. Advances in surgical research allows scientists to now replace dogs’ hips and replace heart valves. 

According to the National Association for Biomedical Research, “modern medical research, including research using animals, is necessary to understanding disease and creating medicines to improve human and animal lives and reduce suffering.  Every known medical breakthrough known has a basis in animal research and all of the top 25 most prescribed drugs were developed with the assistance of animal models.” 

Final Thoughts

Animals have aided in lifesaving measures for both us and their own species. A large reason as to how we know so much about what helps our dogs with cancer, cannabis research, surgical techniques, etc. is because the research was first (or only) tested on animals. This allows us to help our dogs as effectively as possible utilizing research that has already been conducted.  

About Amber Drake

Amber Drake is a highly accomplished, world-renowned, and published book author, freelance writer and editor, inspirational speaker, an inspiring teacher, a well-reputed canine behaviorist, a canine cancer researcher, CEO of Canine Companions, and of course, animal lover. Starting with an Associate of Science degree in Biology in 2007 from Jamestown Community College, she has since expanded her knowledge horizon by acquiring a Bachelor of Science in Biology degree with courses from both SUNY Fredonia and Cornell University, followed by a Master of Arts Degree in Education (2011) from Ashford University, a Post-Master’s Educational Certification, and a Doctorate from the North Central University, Prescott Valley Arizona. Drake is a woman of extreme passion with great love for her work as a canine behaviourist, writer, and college professor.

 

About Angela Ardolino 

Angela Ardolino is a holistic pet expert who has been caring for animals for over 20 years and operates a rescue farm, Fire Flake Farm, in Florida. She is also the owner of  Beautify the Beast,  a natural pet salon and shop. After getting her certificate in Medical Cannabis Biology and Therapeutic use from the University of Vermont School of Medicine, she founded CBD Dog Health to provide high quality, all-natural medical cannabis products designed specifically for pets. Angela has seven dogs, Odie a 12-year-old mini-schnauzer, Nina an 8-year-old Doberman. Jolene a 7-year-old mutt, Maza a 7-year-old mutt, Rhemi an 8-year-old poodle, Potato a 15-year-old shih-tzu, and Miss Daisie a 15-year-old black lab, plus 4-10 more at any time that she is fostering or boarding. She uses Full Spectrum Hemp Extract on all her pets at her rescue farm every day and has since 2016. She is a member of the Society of Cannabis Clinicians, the Veterinary Cannabis Association, and has trained hundreds of medical doctors and veterinarians about the therapeutic uses of medical cannabis on animals. Visit  www.angelaardolino.com for more information.