Drug Development: Discovery to Clinical Trials
Before safe and effective medicines and treatments for disease can be produced, we must understand the disease process by utilizing animal models to find answers to the question “what is going wrong”. Therefore, scientists utilize similar functions animals share with genes in humans. We develop the same way, have the same kinds of organs (heart, brain, lungs, kidneys, etc.), and physical systems (circulatory, reproductive, digestive, nervous) that function very similarly. These models guide science into making data driven decisions for treatments against human diseases.
Prior to the clinical trial phase conducted in humans, critical laboratory research (what is known as “in vivo” or preclinical safety studies) is conducted in animals. In these studies, potential new medicines are tested to evaluate how a medicine functions in a living organism. In this way, animals have contributed to lifesaving treatments in the areas of cancer, diabetes, vaccines, high blood pressure, and neurological disorders, just to name a few.
Even with all the scientific advancements of today, little is known about the complex human system and more research needs to be completed. Drug development is complex, beginning with basic research of disease, moving into drug discovery, in vivo studies to determine safety and potential efficacy of a medication, and through multiple phases of human clinical trials reviewed by the Food and Drug Administration (FDA) before gaining full approval. The process is rigorous- of 5000 potential new drugs evaluated, only 5 on average will move on into clinical trials, and only 1 will be approved. Without the use of animals prior to clinical trials, the failure rate would be much greater and the safety of humans in the trials would be compromised. This process is not limited to medications: medical devices, drug delivery systems, and other interventions are tested and scrutinized. While the process can vary, all countries in the world have an approval process for new medications that includes contributions from animals to assure a level of safety and efficacy.
Research advances in human and animal medicines have made life better for countless numbers of people as well as animals worldwide. The IOC members recognize and embrace our moral and ethical responsibility for the welfare of animals used in research and for the millions of patients relying on us to produce safe medicines that improves lives, health, and well-being. We support strong policies and principles to ensure that all animal research conducted by our organizations or by third parties on our behalf is in line with our values.