The Virtuous Cycle in Parallel: The Benefits of Integrated Comparative Clinical Trials
Written by Kelsie Timbie, PhD
Published:
The traditional path to bring new medical therapies from the laboratory bench to the patients’ bedside is relatively straight: Test first in cell culture, then in small laboratory animals, next in larger laboratory animals, and finally in humans. However, this process has resulted in a spectacularly high failure rate. Recent studies indicate that less that 10 percent of drugs entering clinical trials receive FDA approval – and that success rate is even lower for chemotherapeutics. Why do so many drugs, particularly chemotherapies, fail in clinical trials? One significant weakness in the development pipeline is the preclinical data used to determine whether a specific drug warrants a clinical trial. This crucial evidence usually comes from small animal studies – in other words, the mouse. Laboratory mice live extremely well-controlled lives: Their diets and environments are sterilized and standardized. Their light exposure and temperature are carefully regulated. Mice in a study are the same age and are virtually indistinguishable genetically. All of this is intentional – it reduces the number of variables and confounding factors, simplifying data analysis. But does this decades-old system do more harm than good?
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