ABSTRACT
Two issues present themselves when using animals to justify and subsequently to predict clinical trial outcomes. First is the question of whether the test species’ result has any clear relationship to the eventual patient study. In a majority of trials, there is little effort devoted to making the logical connection between the two results. Researchers compartmentalize their thinking and often keep these data sets literally in separate files with no crossover comparisons ever being made. It would seem important to “close the circle” (Williams, Lopatin, et al. 2008) and to make direct comparisons of parameters seen in the two sequential studies. Additionally, the preclinical study has taken considerable time and associated cost. If the animal evaluation does not have predictive value for the clinical trial, there should be no further use of the test species with that particular agent. While an alternative animal model may eventually be discovered, it may well be that the appropriate test animal should be homo sapiens from the beginning.
