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A recent comprehensive analysis of translational biomedical research has revealed a stark reality: only 5% of therapies tested in animals gain regulatory approval for human use. This striking statistic, published on June 13 in the open-access journal PLOS Biology, comes from an umbrella review that synthesized findings from numerous systematic reviews to offer a broad perspective on the journey from animal studies to human therapeutic approval.
Animal studies are crucial in basic research, providing vital insights into human diseases and potential treatments. These studies have historically paved the way for significant therapeutic innovations. However, despite their foundational role, a substantial drop-off occurs between animal testing and final human use approval. The analysis by Benjamin Ineichen of the University of Zurich, Switzerland, and his colleagues underscores this challenge, examining 122 systematic reviews that tracked the progression of therapies from animal testing to human application.
The findings are stark: of 367 therapeutic interventions tested across 54 human diseases, only 50% advanced to human studies, 40% reached randomized controlled trials, and a mere 5% obtained regulatory approval. Notably, there was an 86% alignment between the results of animal and human studies, suggesting that while initial results are promising, significant barriers exist before final approval.
The timeline for therapies to move from animal studies to regulatory approval is also considerable. On average, it takes five years for a therapy to progress to any human study, seven years to reach randomized controlled trials, and a decade to achieve regulatory approval.
The study highlights the critical need for improved experimental approaches. The authors advocate for enhanced robustness and generalizability in both animal and human research designs. Such improvements could increase the likelihood of successful translation from animal studies to human therapies, ultimately benefiting both experimental animals and patients in need.
These findings also add a crucial dimension to the ongoing ethical debates surrounding animal research. While the clinical translation of animal studies is often cited as a primary justification, the low rate of final approval calls for a re-evaluation of current practices. Enhancing the quality and applicability of early-stage research could address these deficiencies, potentially leading to higher success rates in developing new therapies for human use.
