barriers

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The Use of a Decision Tree Based on the Rabies Diagnosis Scenario, to Assist the Implementation of Alternatives to Laboratory Animals

Vanessa Carli Bones and Carla Forte Maiolino Molento

Brazilian federal legislation makes the use of alternatives mandatory, when there are validated methods to replace the use of laboratory animals. The objective of this paper is to introduce a novel decision tree (DT)-based approach, which can be used to assist the replacement of laboratory animal procedures in Brazil. This project is based on a previous analysis of the rabies diagnosis scenario, in which we identified certain barriers that hinder replacement, such as: a) the perceived higher costs of alternative methods; b) the availability of staff qualified in these methods; c) resistance to change by laboratory staff; d) regulatory obstacles, including incompatibilities between the Federal Environmental Crimes Act and specific norms and working practices relating to the use of laboratory animals; and e) the lack of government incentives. The DT represents a highly promising means to overcome these reported barriers to the replacement of laboratory animal use in Brazil. It provides guidance to address the main obstacles, and, followed step-by-step, would lead to the implementation of validated alternative methods (VAMs), or their development when such alternatives do not exist. The DT appears suitable for application to laboratory animal use scenarios where alternative methods already exist, such as in the case of rabies diagnosis, and could contribute to increase compliance with the Three Rs principles in science and with the current legal requirements in Brazil.

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Barriers to the Uptake of Human-based Test Methods, and How to Overcome Them

Kathy Archibald, Tamara Drake and Robert Coleman

Although there is growing concern as to the questionable value of animal-based methods for determining the safety and efficacy of new medicines, which has in turn led to many groups developing innovative human-based methods, there are many barriers to their adoption for regulatory submissions.
The reasons for this are various, and include a lack of confidence that the available human-based methods, be they in vivo, in silico or in vitro, can be sufficiently predictive of clinical outcomes. However, this is not the only problem: the issue of validation presents a serious impediment to progress, a particularly frustrating situation, in view of the fact that the existing animal-based methods have never themselves been formally validated. Superimposed upon this is the issue of regulatory requirements, where, although regulators may be willing to accept non-animal approaches in place of particular animal tests, nowhere is this explicitly stated in their guidelines. Such problems are far from trivial, and represent major hurdles to be overcome. In addition, there are a range of other barriers, real or self-imposed, that are hindering a more-predictive approach to establishing a new drug’s clinical safety and efficacy profiles. Some of these barriers are identified, and ways forward are suggested.
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