If you work in drug discovery and development, you are well aware of the failure rate at clinical trials. Industry estimates are that clinical candidates have a 85-90% chance of failure during clinical trials, the most costly stage of evaluation. A report in Nature Biotechnology 32, 40–51 breaks this success/failure rate down between phases as well as the likelihood of approval from the start of clinical trials. For candidates that are suspended during clinical stages, 83% of these reported efficacy or safety as the reason for suspension.
This is costly and time consuming for drug developers. So is there a way to increase the predictability from preclinical phases to clinical phases? We have been evaluating this question for a number of years in our Research Group at MD Biosciences. Animal models used in preclinical development phases are pivotal for understanding mechanisms that contribute to human disease conditions and effective therapies. Rodent models are commonly employed due to their reproducibility and simplicity, however the predictability to the clinic is often times lacking.