Oncology Certified Nurse (OCN) Nursing Practice Test

What is the primary focus of a Phase 2 clinical trial?

1. Assess response rate of treatment

2. Determine the toxicity of new drugs

3. Compare new drugs to existing treatments

4. Identify molecular targets

The correct answer is: Assess response rate of treatment

The primary focus of a Phase 2 clinical trial is to assess the response rate of treatment. During this stage, the efficacy of the drug or treatment is evaluated in a larger group of participants who have the specific condition the treatment targets. The goal is to determine whether the treatment has the desired effect on the disease, usually measured by the objective response rate, such as tumor shrinkage or other clinical benefits. This phase typically involves monitoring various outcomes, including secondary endpoints like duration of response and the quality of life for participants, as well as gathering additional safety data. Assessing response rates helps determine whether to proceed to Phase 3 trials, where the treatment can be compared against standard care in a more extensive patient population. While toxicity assessment is an important part of Phase 1 trials, in Phase 2 trials, toxicity is monitored but is not the primary focus; the main aim is to establish efficacy. Comparisons with existing treatments are generally more characteristic of Phase 3 trials, where the new intervention is tested against therapies already proven to be effective. Identifying molecular targets usually takes place in early preclinical phases or in specific targeted therapy trials, not specifically in Phase 2. Thus, the central aim of assessing response rate is crucial in advancing the development