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

What is the main focus of a Phase 3 Clinical Trial?

1. Assessing safety

2. Determining cost-effectiveness

3. Establishing is it more effective than current therapies

4. Understanding the pharmacokinetics

The correct answer is: Establishing is it more effective than current therapies

A Phase 3 Clinical Trial primarily serves to establish whether a new treatment is more effective than the current standard therapies. This phase of clinical research is critical as it often involves a large patient population and compares the new drug or intervention against a control or placebo, which is typically the existing treatment. The objective is not just to show that the new treatment works, but also to demonstrate its efficacy in a real-world context, assessing how it performs against existing options used to manage the condition. This trial phase helps in determining if the benefits outweigh the risks and if it should be approved for widespread clinical use. By generating robust evidence on effectiveness and safety, Phase 3 trials are pivotal for regulatory approval and clinical guidelines. While safety assessments, cost-effectiveness, and pharmacokinetics are important considerations in clinical research, they are not the primary focus of Phase 3 trials. Those aspects might be evaluated in earlier phases or through separate studies aimed at specific goals.