Advanced Dental Admission Test (ADAT)

What characterizes Phase 2 of a clinical trial?

1. Testing a large number of healthy participants

2. A small number of diseased participants

3. Long-term post-marketing surveillance

4. Assessing only safety without treatment efficacy

The correct answer is: A small number of diseased participants

Phase 2 of a clinical trial is characterized by testing the treatment in a small number of individuals who have the condition that the therapy aims to treat. This phase is critical as it aims to assess the efficacy of the treatment in this specific patient population while also continuing to monitor for safety. Researchers typically expand upon the preliminary safety findings from Phase 1 trials to determine if the treatment produces the desired effect in individuals with the disease. While the focus is on both safety and efficacy during this phase, the inclusion of a larger and more targeted sample of diseased participants helps establish dosage ranges, further evaluate safety, and identify potential side effects. This differs greatly from Phase 1 trials, which primarily involve healthy volunteers, and from later phases, which test larger groups and expand to diverse patient populations. Thus, identifying a small number of diseased participants is a hallmark characteristic of Phase 2 clinical trials.