Author + information
- Gail A. Van Norman, MD∗ ()
- ↵∗Address for correspondence:
Dr. Gail A. Van Norman, Department of Anesthesiology and Pain Medicine, University of Washington, 2141 8th Avenue West, Seattle, Washington 98119.
Dramatically rising costs in drug development are in large part because of the high failure rates in clinical phase trials. The poor correlation of animal studies to human toxicity and efficacy have led many developers to question the value of requiring animal studies in determining which drugs should enter in-human trials. Part 1 of this 2-part series examined some of the data regarding the lack of concordance between animal toxicity studies and human trials, as well as some of the potential reasons behind it. This second part of the series focuses on some alternatives to animal trials (hereafter referred to as animal research) as well as current regulatory discussions and developments regarding such alternatives.
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.
- Received March 25, 2020.
- Accepted March 25, 2020.
- 2020 The Author