Currently, only 11 percent of drugs that enter clinical trials in humans are ultimately found safe and effective enough to receive regulatory approval. One possible reason for the low success rate is flawed preclinical animal research. In short, drugs are being advanced into clinical trials without reliable evidence that they are useful.
For a study published in PLoS Medicine, researchers conducted a systematic literature search and identified 26 guidelines with 55 different procedures that groups of scientists have proposed to improve the quality and usefulness of preclinical efficacy studies for investigational drugs.
Many of these recommendations aren’t widely implemented in preclinical research.
This also raises ethical concerns, because patient trials are expensive and involve burdens on the patients. Additionally, if we are not learning all we can from the animal studies in drug development, this leads to failed drug development and ultimately, higher drug prices. Read more