The design of combination therapy trials often involves multiple stages: - Preclinical Studies: These are conducted in the laboratory and involve cell lines and animal models to evaluate the potential efficacy and safety of the drug combination. - Phase I Trials: The primary goal is to determine the maximum tolerated dose (MTD) and identify any potential side effects. - Phase II Trials: These trials assess the efficacy of the combination in a specific patient population, typically focusing on a particular type of cancer. - Phase III Trials: These are large-scale studies that compare the new combination therapy to the current standard of care to determine its overall benefit.
