Why Do Preclinical Humane Endpoints Matter?
When people are suffering or dying from disease, there’s a powerful incentive to move new treatments through the pipeline as quickly as possible. But while speed is important, it cannot come at the expense of quality and compliance. The care of animals involved in preclinical safety studies is a compliance expectation by several regulatory bodies, and because the animal is the test system, good animal welfare is also good science.
Establishing humane endpoints before a study begins is the right thing to do. It is an ethical expectation of the public, and it makes good business sense; humane endpoints can reveal crucial insights on a drug candidate’s mechanism of action and strengthen the rationale for a go/no-go decision.
Identifying humane endpoints and including them in a study design can be a challenge. The goal is to set criteria that meet study objectives while ending the study as early as possible to avoid or stop unrelieved pain or distress in an animal. That goal aligns with guidance from the National Institute of Health (NIH) Office of Animal Welfare. A study that carries on past those criteria is neither humane nor scientifically justified.
Full article at Drug Discovery Online