Oncology Certified Nurse (OCN) Nursing Practice Test

A patient with cancer is considering entering a clinical trial that compares the standard treatment with an investigational drug. This is an example of which phase of a clinical trial?

1. Phase 1

2. Phase 2

3. Phase 3

4. Phase 4

The correct answer is: Phase 3

This scenario describes a clinical trial that is comparing a standard treatment with an investigational drug, which is characteristic of Phase 3 clinical trials. Phase 3 trials are designed to assess the effectiveness of a new treatment in comparison to the current standard of care. These trials usually involve a larger patient population and are crucial for determining whether a new treatment offers a significant benefit over existing options with regard to efficacy, safety, and overall outcomes. In contrast, Phase 1 trials focus primarily on assessing the safety of a drug, determining the appropriate dosage, and identifying possible side effects in a small group of participants. Phase 2 trials involve a larger group and are primarily aimed at evaluating the drug's effectiveness and further assessing its safety, but they do not compare it directly with standard treatment. Phase 4 trials occur after a drug has been approved and are conducted to monitor long-term effects and gather more information about the drug's risks and benefits in a broader population. Thus, the correct answer signifies a pivotal stage in drug development where the investigational treatment is evaluated in comparison to the established standard treatment for its effectiveness and safety.