Certified Clinical Research Coordinator (CCRC) Practice Exam

Large multi-center studies are usually conducted during which phase of drug development?

1. Phase I

2. Phase II

3. Phase III

4. Phase IV

The correct answer is: Phase III

Large multi-center studies are typically conducted during Phase III of drug development. This phase is crucial as it involves the extensive testing of a new drug in a larger population across multiple sites to assess its efficacy, safety, and side effects compared to a control group. The objective is to gather enough data to determine whether the drug can be effectively marketed. During Phase III, researchers aim to confirm preliminary evidence of efficacy obtained in earlier phases while also monitoring for any adverse reactions that may not have been evident in smaller studies. Given the comprehensive nature of Phase III trials, multi-center designs are often employed to ensure diverse participant enrollment, which helps in validating the results across different demographics and geographic locations. This facilitates a better understanding of how the drug performs in a real-world context and establishes a robust dataset for regulatory approval. In contrast, Phase I trials usually involve small groups of healthy volunteers to assess safety and dosage, while Phase II focuses on a larger group of individuals to evaluate efficacy and further safety in patients with the condition being treated. Phase IV occurs post-marketing and involves further studies to monitor long-term effects and gather additional information on the drug's performance in the general population. Hence, Phase III is distinctively characterized by its scale and objectives, making it the correct choice