What are alternatives?

The term ‘alternatives’ is used to refer to methods that replace research where animals have previously or are currently being used.  These methods are sometimes referred to by other names including ‘replacement’,  ‘non-animal’ or ‘new-approach’ methods. FRAME has always believed that to improve scientific outcomes in human health research and safety testing these alternative approaches should be ‘human-based’ in other words based on human biology and human tissue, rather than that of another species.

These alternative methods are generally human-based but some use historic data from animal research or use animal tissue. Whilst these animal-based methods may remove the need for further use of laboratory animals they are not going to be as valid as those based on human biology.

There are growing numbers of alternative research and testing methods available, including, but not limited to:

• Cell Culture – in vitro methods that use and grow human cells and tissue within a laboratory setting, which might include tissue donated by patients, lab-cultured tissue, or stem cells. Scientists can now create three-dimensional ‘mini-organs’ known as organoids and mini devices to mimic whole organs known as organ-on-a-chip.
• Organ-on-a-chip – a type of in vitro technique that can use a range of human cells in small microfluidic chips to enable the study of a whole organ, or to study a whole system or in theory, an organism, by using many chips together. These systems can replicate the flow and diffusion of nutrients, waste products and drug metabolites, to give more detailed and realistic models of a human response.
• In silico – methods that use computers, mathematical models and simulations to predict, for example, human responses to a compound, or to model the progression of disease and treatments within the human population.
• Human volunteers – this includes techniques such as micro-dosing, for example, where people are given very small amounts of a chemical to find out how it is metabolised prior to large-scale human trials or to study skin sensitivity. Volunteers can also provide human tissue needed for in vitro research.
• Human patient studies – where studies are carried out on patients suffering from a particular condition or disease. Data is obtained, collated and studied or treatments given with permission. There is a concerning trend over recent decades to try and recreate human conditions in animals using genetic modification. Where it is possible to obtain information directly from patients themselves, research is going to provide more relevant insights than mimicking the disease in an animal. 

In all these alternative areas new techniques are continually being developed and modified. However, for testing the safety of drug and chemicals in particular, it is currently not possible to replace a particular animal test with one ‘alternative’. A combination of in vitro and in silico techniques may be needed to provide the required safety data. Alternative approaches to animal use, particularly when used in combination at appropriate phases of drug discovery and/or toxicity testing, can provide better predictions of human adverse outcomes as they are more human-relevant.