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# FDA Needs to Modernize Preclinical Testing: Policy Expert
- URL: https://www.fdaweb.com/fda-needs-to-modernize-preclinical-testing-policy-expert/
- Published: 2016-03-07T12:00:00.000Z
- Updated: 2026-09-15T02:41:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134984

> FDA needs to modernize preclinical tests to improve patient safety, according to *Physicians Committee for Responsible Medicine senior science policy specialist for toxicology and regulatory testing *Elizabeth Baker*. Writing in a the Hill* [*blog posting*](http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=newssearch&cd=5&cad=rja&uact=8&ved=0ahUKEwi-vruf46%5FLAhVD6x4KHZqUCSQQqQIIKSgAMAQ&url=http%3A%2F%2Fthehill.com%2Fblogs%2Fcongress-blog%2Fhealthcare%2F271830-fda-accept-human-focused-preclinical-tests-to-improve-drug&usg=AFQjCNFozfaqFkhNfYZNqxWihfIEcMyKwQ&bvm=bv.116274245,d.dmo)*, Baker noted that p*atient deaths halted at least two pharmaceutical clinical trials in the last two months, and said that new commissioner **Robert Califf**, whose specialty is clinical trial designs, should address this issue and require more human biology-based tests for preclinical drug testing and less animal tests.  
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> Baker expressed her disappointment with drug developers continuing to use animal tests, even when a newer method may be more human-relevant, because FDA regulations and reviewers continue to require them. “Many human-relevant technologies that will improve patient safety and reduce preclinical animal tests already exist, and many others are in development and continue to emerge,” she said.  
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> Baker recommended that FDA should:  
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> Amend existing regulations to clearly state that drug sponsors can submit data from human-based test methodsIssue guidance that clearly communicates when modern test methods are accepted;Facilitate the acceptance of modern test methods that are demonstrated to be more predictive of human responses to new drugs.  
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> “I look forward to Califf’s leadership at the FDA and encourage him to prioritize the modernization of preclinical testing methods,” she said. “More than 100,000 drug or biologic clinical trials are registered with [ClinicalTrials.gov](https://clinicaltrials.gov/ct2/resources/trends?ref=fdaweb.com#LocationsOfRegisteredStudies) and nearly [60 percent of Americans are taking prescription drugs](http://media.jamanetwork.com/news-item/increase-seen-in-prescription-drug-use-in-u-s/?ref=fdaweb.com). These patients need safer and more effective treatments—and 21st-Century human-focused test methods will ensure they get them.”