Advanced Dental Admission Test (ADAT)

Which type of trials includes a large sample size of diseased participants?

1. Phase I

2. Phase II

3. Phase III

4. Phase IV

The correct answer is: Phase III

Phase III trials are designed to evaluate the effectiveness and safety of new treatments on a larger scale before they can be approved for general use. These trials typically involve a substantial number of participants who have the specific disease or condition that the treatment aims to address. The large sample size is essential because it allows researchers to gather more robust data regarding how well the new intervention works compared to standard treatments or placebos. In Phase III trials, stratification based on patient demographics and other variables helps ensure that results are generalizable across diverse populations. The focus is not only on efficacy but also on monitoring adverse effects and further clarifying the risk-benefit profile of the treatment. This stage is critical for gaining regulatory approval, as it provides the comprehensive evidence needed to determine if a new therapy should be made widely available to patients. Other phases, such as Phase I, primarily involve smaller groups of healthy volunteers to assess safety, while Phase II focuses on a targeted group of patients to evaluate effectiveness with a moderate sample size. Phase IV trials occur after a treatment is approved and often involve different objectives, such as long-term side effects or new applications of the treatment in the general population. Thus, the primary characteristic of Phase III trials is their inclusion of a large sample of individuals