March 21, 2016

FDA: Accept Human-focused Preclinical Tests to Improve Drug Safety

Patient deaths halted at least two pharmaceutical clinical trials in the last two months. The good news is, Robert Califf, M.D., who was confirmed by the Senate last week as commissioner of the Food and Drug Administration, has an opportunity to address this issue. In his new role, Dr. Califf is in a position to improve patient safety—from clinical trial participants to consumers—by modernizing preclinical tests.

Preclinical research is critical to gathering safety information before a drug is tested in humans. However, the existing paradigm largely depends on animals to predict what will happen in humans. As evidenced by recent unfortunate events, this system often fails.


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