Preclinical Methods

Preclinical studies, including in vitro studies with cells and in vivo studies with animal models, comprise a critical facet of cancer research. These preclinical studies are a critical starting point for elucidating mechanisms of diseases and discovery of novel molecularly targeted agents. Through biomarker discovery and establishing proof-of-concept principles, preclinical studies also lay the framework for incorporation of translational endpoints into trial design. Usually, preclinical studies are not very large. However, these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their fi ndings and decide whether the treatment regiments and drugs should be tested in patients and whether they should move forward with large-scale clinical trials in which patients may be exposed to potentially toxic therapy.