Improving the Utility and Translation of Animal Models for Nervous System Disorders Workshop Summary (2013) / Chapter Skim
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1 Introduction and Overview
1 Introduction and Overview
Pages 1-8
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Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice.
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• Identify methods that would maximize bidirectional translation between basic and clinical research. • Determine the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.
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Several participants noted that improved stratification of models, to match specific components of disease mechanisms or phenotypes, might lead to a greater ability to answer well-defined questions and the eventual devel opment of better therapeutics. Following on this point, there was some discussion about not labeling models as a model of a whole disease or disorder (e.g., an animal model of schizophrenia)
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A few participants noted that increasing the level of in formation detailed in publications, including the explicit reporting of replication of experimental results, would also be beneficial. Several participants emphasized the importance of reproducibility and the scientific validity of data as decisions are made about when to move from the laboratory into clinical trials.
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• Bidirectional translation: Many participants believed that ani mal models and human clinical research inform each other through bidirectional translation, from the bench to bedside and back again. Several participants discussed the importance of cross-validation of animal model endpoints with clinical measures and of clearly establishing what the corresponding endpoint is intended to predict.
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Several participants expressed concern over the deficien cies that current trainees have in basic research design and statistical analysis which are prerequisites for conducting any ex periment. Many participants highlighted specific examples of ar eas where knowledge of and focused training on might be beneficial, including identification of primary experimental hy potheses and outcome measures; the importance of predefining analyses plans and inclusion and exclusion criteria; completion of sample size calculations; and identification of dependent and independent variables.
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In particular, one participant noted that if the mouse models for polygenic psychiatric disorders are really as poor as described, perhaps it is time to ask under what circumstances it would be both worthwhile and ethical to go straight into human clinical trials after establishing safety. Should research continue with the current emphasis on animal models, or should more fo cus be placed on cellular models and/or Phase 04 human clinical trials?
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