Certified Clinical Research Coordinator (CCRC) Complete Practice Exam 2025

The majority of safety and efficacy data in clinical trials are collected during Phase III. This phase is critical as it involves a larger patient population and is designed to confirm the findings from earlier phases. Phase III trials typically include hundreds to thousands of participants and aim to establish if the experimental treatment is effective compared to standard therapies or placebo.

During this phase, researchers gather comprehensive data regarding how well the treatment works and monitor for adverse effects across a diverse group of patients. The results obtained in Phase III are crucial, as they provide the robust evidence needed for regulatory approval and are often the basis for labeling and marketing the new therapy.

Subsequent phases, such as Phase IV, focus on post-marketing surveillance and the long-term effects of the treatment, while earlier phases (I and II) primarily aim at dose-finding and initial safety assessments. Thus, while vital, those phases do not yield the expansive data set characterizing Phase III.