The benefits of validation of methods for toxicity testing outweigh its costs

In September 2022, the 4th Annual Forum on Endocrine Disrupters organised by the European Commission brought together authors of this article around the following topic: “From bench to validated test guidelines: (pre)validation of test methods”. Validation activities are meant to demonstrate the relevance and the reliability of methods and approaches used in regulatory safety testing. These activities are essential to facilitate regulatory use, still they are largely underfunded and not attractive to the scientific community. In the last decade, there has been large amounts of funding invested in European research towards the development of approaches that can be used in regulatory decision-making, including for the identification of endocrine disrupters. There is a vast pool of candidate test methods for potential regulatory applications but most of them will not be used due to the absence of consideration of their relevance and reliability outside the method developer’s laboratory. The article explains the reasons why such a gap exists between the outputs of research projects and the uptake in a regulatory context. In parallel, there are also increasing expectations from the regulatory science community that validation becomes more efficient with repect to both time and resources. This article shares some of the lessons learned and proposes some paths forward for validation of new methods that are not intended as one-to-one replacements of animal studies. This includes submitting only mature methods for validation that were developed following good practices and good documentation, proposing a greater emphasis on well-documented transferability studies and adopting a cost-sharing model between those who benefit from validated methods.

GOURMELON Anne;  HUBERT Philippe;  GRIGNARD Elise;  BAUMANN Lisa;  MUNN Sharon;  MICHEL-CAILLET Cécile; 

2024-10-21

SPEKTRUM AKADEMISCHER VERLAG-SPRINGER-VERLAG GMBH

JRC137442

1868-596X (online),   

https://www.altex.org/index.php/altex/article/view/2773/version/2835,    https://publications.jrc.ec.europa.eu/repository/handle/JRC137442,   

10.14573/altex.2403051 (online),