Regulatory Affairs Certification (RAC) Practice Exam

What is the main purpose of Phase 2 clinical investigations for a new drug?

1. To determine long-term effects and risks

2. To assess marketing strategies

3. To identify common short-term side effects and risks

4. To evaluate post-marketing safety

The correct answer is: To identify common short-term side effects and risks

Phase 2 clinical investigations primarily focus on assessing the efficacy of a new drug and identifying common short-term side effects and risks associated with its use. This phase follows the initial safety testing in Phase 1, where the primary goal is to evaluate the drug’s safety and pharmacokinetics in a small group of healthy volunteers. In Phase 2, the drug is given to a larger group of patients who have the condition the drug is intended to treat. This phase helps gather more information about the drug's effectiveness in treating the disease and further evaluates its safety profile. The information collected during this stage is crucial for determining appropriate dosing, potential side effects, and any short-term risks that might be associated with the medication. These findings are essential for informing the design of later-phase trials, specifically Phase 3 trials, which seek to confirm effectiveness and monitor adverse reactions in a broader population. While the other options touch on relevant aspects of drug development, they do not align directly with the specific objectives of Phase 2 trials. Long-term effects and risks, for instance, are typically assessed in later phases. Similarly, evaluating marketing strategies or post-marketing safety falls outside the clinical trial phases focusing directly on pharmacological data collection.