What is the main purpose of Phase I clinical trials?

The main purpose of Phase I clinical trials is to test for safety. These trials typically involve a small number of participants and focus primarily on assessing the safety of a new drug or treatment. Researchers monitor participants for any adverse reactions and gather data on how the drug is metabolized and excreted. The insights gained during this phase are crucial for establishing a safe dosage range before further testing occurs in Phase II trials, where the focus shifts to examining efficacy and side effects in a larger group.

While obtaining FDA approval is a critical goal for all clinical trial phases, it is not the primary focus of Phase I trials. Similarly, cost-effectiveness and comparisons of safety and effectiveness are considerations that become more relevant in later phase trials, particularly in Phase III, where larger datasets can better support these analyses.