According to an analysis of reviews of translational biomedical research, only 5% of treatments that are tested in animals are approved for human use by regulatory agencies. The study, known as an umbrella review and published on June 13 in the open access journal PLOS Biology, summarizes other systematic reviews and offers strong evidence that while the translation rate to human studies is 50%, there is a significant decrease before final approval.The systematic reviews reveal that only 50% of studies translate to human studies, and there is a sharp decline in the final approval process. The authors suggest that improving the robustness and generalizability of experimental approaches could increase the likelihood of translation and final approval.
Animal studies are crucial for understanding human diseases and have led to some therapeutic advancements. However, there are multiple steps before a treatment can be approved for human use. Ethical debates surround animal research, but it remains an essential part of basic research.The primary reason for conducting such work is to facilitate the initial translation, but the evidence of how many studies successfully progress through each stage and gain approval is limited. Benjamin Ineichen and his team from the University of Zurich, Switzerland, conducted a meta-analysis of 122 systematic reviews that examined the translation of therapies from animals to humans. They analyzed the progression of these therapies to human studies, randomized controlled trials, and regulatory approval, while also assessing the consistency between results from animal and human studies. The analysis revealed that out of 367 therapeutic interventions tested in 54 human diseases, 50% advanced from animal studies to human trials.Animal studies account for 55% of the total research, followed by 40% for randomized controlled trials, and a mere 5% for regulatory approval. The alignment between animal and human studies is quite high at 86%, with an average time period of five years for human studies, seven years for randomized controlled trials, and 10 years for regulatory approval.
Despite the higher number of studies reaching the initial stage, the low rate of final approval indicates potential deficiencies in the design of both animal and early clinical studies. The authors suggest that improving the transition from animal to human research is crucial.We support improving the strength of research designs for both animal and human studies, which will have positive impacts on both experimental animals and patients.
