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

The type of clinical trial that is conducted to assess the efficacy and side effects of a new drug in a small population is typically a Phase II trial. Phase II trials are specifically designed to evaluate the effectiveness of the drug after initial safety has been established in Phase I trials. During this phase, researchers closely monitor the participants for both the therapeutic effect of the drug and any adverse reactions or side effects.

The focus on a relatively small group allows for a more thorough assessment of the drug's performance in terms of efficacy, which is achieved through specific endpoints related to the condition being treated. Moreover, this phase is crucial for determining the dosing regimen and further refining the understanding of the drug's safety profile in a slightly larger but still controlled environment.

In contrast, Phase I trials primarily focus on the safety of the drug, often involving healthy volunteers to identify side effects and determine safe dosage levels. Phase III trials are conducted on larger populations to confirm efficacy, monitor side effects, and compare the new drug to standard treatments. Phase IV trials occur after a drug has been approved for marketing and can involve even larger populations to monitor long-term effects and efficacy in the general population.