Reducing Animal Testing During Toxicology Testing
The company seeks to discover and develop new human drugs, a process that involves testing procedures and the use of animals as test specimens. Ethical issues, however, have been raised against the use of animal testing, and individuals and groups are advocating for the non-use or reduced use of animals in toxicological testing of newly developed drugs. The owner of the company is an ethically sensitive people to the use of animals in toxicology testing and he has asked for a minimization of the use of animals during testing. Possible strategies for reducing animal testing during toxicology testing are discussed.
The use of effective and efficient research methods and designs is the proposed solution. The existing regulatory guidance and empirical data on the principles of reduction, refinement, and replacement of animal use in toxicology research inform the decision. One of the regulatory guidelines in the European Union, which can affect the market for the company’s developed products in the region, is the need to use scientific tests that do not involve animals (The European Medicines Agency, 2014). The number of animals used in a study, if the usage is necessary, should be minimal but guarantee the fulfilment of test objectives. The guideline also provides for the refinement of the environments in which animals stay before a test study, and the refinement of research methods for the elimination of pain or distress that animals may suffer because of their use in research (The European Medicines Agency, 2014). One of the implications of the guidance is the need to replace animals with alternative tests, unless such a replacement is not possible. The replacement can be achieved through alternative methods such as computer models and in vitro models that simulate the processes that could occur in animals if they were used for tests. The modeling can generate preliminary results for the refinement of the use of animals or can suffice the targeted test goals. Similarly, reliance on data from existing studies and practical considerations of theoretical information can suffice or provide information for refining studies involving the use of animals. The use of modeled results in subsequent and refined tests, which use animals, has the effect of increased validity and reliability and substantiates the need for fewer animals and number of tests for confirmatory results.
The provisions of the guidance for refinement of the environment around animals, before and during a test process, also offer a basis for the reduction of the number of used animals through the principle of refinement. The elimination or reduction of pain and distress, prior to and during a test, has the effects of improving the animals’ physiological condition that is necessary for accurate response to test treatments. Distress and pain, for example, may reduce an animal’s sensitivity to a treatment into undervaluation of treatment effects. Increased effects of the environment to the animals’ sensitivity, however, may lead to overvaluation of the effects of a treatment and undermine the goal of a toxicology test. Improved research methods into high levels of precision also mean the ability to realize acceptable levels of validity and reliability with fewer animals per test and fewer tests. Refinement, therefore, also eliminates the need to use more animals in repeat tests for establishing validity of results. The concepts of reduction, refinement, and replacement of animal usage in toxicology testing, therefore, define strategies for addressing the concern of minimized animal use in toxicology testing (The European Medicines Agency, 2014).
Empirical data supports the significance of methodological refinement in reducing the number of animals used in toxicology research. Methodological and design features of animal test studies influence the minimum applicable number of animals for a satisfactory test outcomes and form a basis for reducing the number of animals in a study (Tornqvist et al., 2014). Data from projects on the reduction of the number of animals in toxicology research illustrates this through a demonstration of a significant effect of applicable reduction measures on the number of used animals. The use of reduction strategies, according to Tornqvist et al. (2014), reduces the threshold number of animals by 53 per cent for rats, 34 per cent for mice, 19 per cent for dogs, and eight per cent for rabbits. Improvements in study methods, based the study by Tornqvist et al. (2014) in which rats were the majority of the used animals, accounts for 68 per cent of the achieved reduction in the number of used animals while improvements in study design account for 20 per cent of the reduction. Tactful coordination of elements of a study is also significant to the reduction of the number of animals in a toxicology research (Tornqvist et al., 2014).
Some researchers may be skeptical about the implementation of practices that pursue the reduction, refinement, and replication principles, while others acknowledge the need to consider minimal use of animals in toxicology research. The cost of using animals in research, and the surrounding ethical issues are some of the factors that researchers are willing to consider, and could lead to such decisions as non-use of animal research and better treatment of animals in research processes (Fenwick, Danielson, & Griffin, 2011). Other researchers, however, are likely to embrace methodological approaches for the reduction of the number of animals per test, if the reduced number promises valid results (Fenwick et al., 2011).
The company seeks to discover and develop new human drugs. The processes often require animal testing but there is a need to minimize the number of animals during toxicology testing. The concepts of reduction, refinement, and replacement identify possible approaches for addressing the minimization concern. Improved research methods and favorable environments for animals to be used in tests, which are elements of the reduction and refinement principles, have been associated with accurate and generalizable results and the associated need to use fewer animals for toxicology tests. Use of alternatives to animal tests, such as computer models and in vitro test models can also minimize or eliminate the number of animals in toxicology testing. Empirical results support the effectiveness of research method and design, as well as coordination of elements and activities of research, in reducing the number of used animals in tests. Similarly, the use of alternatives such as read-across other sources, reliance on existing tests, practical consideration of theoretical knowledge, and non-animal approaches have demonstrated, empirically, the significance in minimizing the number of animals in toxicology testing.
Evidence exists on the ability to minimize the number of animals used in toxicology research. Validity and reliability of the quantitative studies, and credibility and dependability of the qualitative study are assumed in proposing the solution. The sources contained all the necessary information for establishing the solution. Some toxicology studies do not require the use of animals while others require the use of fewer animals than drug developers may perceive. The use of effective research methods and designs is recommended for ensuring that animals are used effectively and on necessity. The role of preliminary reductionist approaches on the development of efficient and effective research methods and designs, and the role of collaboration with regulatory authorities on understanding the threshold number of animals informs the recommendation. An understanding of alternative methods to animal research and the effectiveness of the methods is also recommended for preliminary studies into the development of focused, effective, and efficient research methods and designs. Read-across options, use of existing test results, practical considerations on theoretical information, computer models, and in vitro models should be the focus of the preliminary studies. All activities in the test processes should also be coordinated for improved test outcomes.
1. Fenwick, N., Danielson, P., & Griffin, G. (2011). Survey of the Canadian animal-based researchers’ views on the three Rs: Replacement, reduction, and refinement. Plos One, 6(8), e22478. doi:10.1371/journal.pone.0022478.
2. The European Medicines Agency. (2014). Guideline on regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches. The European Medicines Agency. Retrieved from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500174977.pdf.
3. Tornqvist, E., Annas, A., Granath, B., Jalkensten, E., Cotgreave, I., & Oberg, M. (2014). Strategic focus on 3R principles reveals major reductions in the use of animals in pharmaceutical toxicity testing. Plos One, 9(7), 1-11.