American Board of Surgery Qualifying Exam (ABS QE) Practice Test

Which question best represents the focus of a Phase 2 Clinical Trial?

1. Is it safe?

2. Does it provide better outcomes than existing options?

3. Is it effective?

4. What is its market potential?

The correct answer is: Is it effective?

A Phase 2 Clinical Trial primarily focuses on assessing the effectiveness of a treatment or intervention. This phase follows the initial safety assessments conducted during Phase 1 trials, where the primary concern is usually whether the drug or treatment is safe for human use. In Phase 2, the objective shifts to determining how well the treatment works. Researchers aim to gather preliminary data on effectiveness, often using measurable outcomes relevant to the disease or condition being studied. They are looking for an indication that the treatment produces the desired therapeutic effect, thus establishing a foundation for further investigation in Phase 3 trials, where larger populations are involved. While assessing safety is crucial, that aspect is typically a focus of earlier phases. Market potential is generally evaluated in later stages of development, once efficacy and safety have been established, and comparison with existing treatment options is usually more pertinent in Phase 3 trials when direct comparisons can be made.