Toward a human-focus paradigm in health research
The Animal Model Framework: Scoring Animal Models to Build Replacement Strategies
The ongoing crisis of the translation of scientific findings into treatments for human diseases is widely recognized within the pharmaceutical industry and academia alike. Reasons behind high attrition rates are multifaceted, including methodological flaws and inherent limitations of animal models of human diseases1.
The value of animal models in predicting the effectiveness of treatment may be based upon long-standing scientific practices and traditions, rather than their potential for accurate predictivity2. In biomedical research, the continued use of animal models with low translational value may obscure our understanding of disease, whilst hindering the development of safe and effective treatments for human disease.
BioMed21 is coordinating a pilot study to assess the translational relevance of animal models of human diseases in a critical, scientific, and standardized way, using the Framework to Identify Models of Disease (FIMD)3 to do so. FIMD is a pioneering tool that consists of a questionnaire organized into eight domains. Ultimately, FIMD assesses and compares animal models with the human conditions that they aim to replicate.
Global experts in the fields of clinical medicine, animal models and translational research are researching and reviewing the pilot study, aiming to assess the applicability of FIMD to evaluate and score two animal models of sepsis according to their translational relevance. The need for a simplified version of FIMD to identify animal models with no or low translational relevance is also being evaluated in the current pilot study.
If successful, the Animal Model Framework (AMF) project could be expanded to assess animal models for many disease areas, helping academic researchers, funding agencies, regulators, and other stakeholders within the field of research and drug development to assess the translational relevance of animal models with sound scientific criteria in a standardized way.
Data from the AMF project can be used to:
- inform funding and research strategies
- discontinue low-scoring models
- identify priority areas for development
- increase the use of New Approach Methodologies (NAMs)
Do not hesitate to contact us if you are interested in the results of this pilot study or if you would like to join the working groups for the current or next projects.
Bianca Marigliani:
bmarigliani@hsi.org
