Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

In early-phase clinical trials, particularly Phase I trials, the primary focus is on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug. Because these trials involve a small number of participants—often healthy volunteers—the quantities of the drug required are typically smaller compared to later-phase trials, which test efficacy in larger populations.

The rationale for using smaller quantities in early-phase trials is that these studies often aim to find the maximum tolerated dose or to evaluate the effects of the drug at various dose levels. This meticulous approach allows researchers to gather essential safety data without exposing too many participants to potentially harmful effects. Additionally, the objective is to establish a safe dosage range before progressing to more extensive trials where larger quantities would be necessary to demonstrate efficacy and gather more comprehensive data on the drug's effects.