Translational Perspective
Limitations of Animal Studies for Predicting Toxicity in Clinical Trials: Is it Time to Rethink Our Current Approach?

https://doi.org/10.1016/j.jacbts.2019.10.008Get rights and content
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Summary

Animal testing is used in pharmaceutical and industrial research to predict human toxicity, and yet analysis suggests that animal models are poor predictors of drug safety in humans. The cost of animal research is high—in dollars, delays in drug approval, and in the loss of potentially beneficial drugs for human use. Human subjects have been harmed in the clinical testing of drugs that were deemed safe by animal studies. Increasingly, investigators are questioning the scientific merit of animal research. This review discusses issues in using animals to predict human toxicity in pharmaceutical development. Part 1 focuses on scientific concerns over the validity of animal research. Part 2 will discuss alternatives to animal research and their validation and use in production of human pharmaceuticals.

Key Words

animal research
drug development
toxicity
translational research

Abbreviations and Acronyms

FDA
U.S. Food and Drug Administration
LR
likelihood ratio
NLR
negative likelihood ratio
NPV
negative predictive value
PLR
positive likelihood ratio
PPV
positive predictive value

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Dr. Van Norman has received financial support from the Journal of the American College of Cardiology.

The author attests they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Basic to Translational Science author instructions page.

© 2019 The Author. Published by Elsevier on behalf of the American College of Cardiology Foundation.