Chemotherapy Biotherapy Certification ONS Practice Testq

What is mainly assessed in Phase 3 of a clinical trial?

1. Tolerable dose

2. Survival rate and quality of life

3. Drug side effects

4. Initial drug activity

The correct answer is: Survival rate and quality of life

In Phase 3 of a clinical trial, the focus primarily shifts to evaluating the efficacy and safety of a new treatment in a larger population. This phase is typically designed to confirm the clinical benefits observed in earlier phases and often aims to provide definitive data on how the treatment performs compared to standard therapies or placebos. Survival rate and quality of life are key outcomes measured during this phase. By assessing these parameters, researchers can determine not only whether the new therapy improves survival chances compared to existing treatments but also how it impacts patients' overall well-being and daily functioning. Gathering this comprehensive information is critical for regulatory approval and informing clinical practice. Other phases target different aspects; for instance, earlier phases look more at initial drug activity and tolerable doses. Therefore, while drug side effects are considered in Phase 3, they are part of a broader assessment of overall treatment efficacy and patient experience, making the survival rate and quality of life the central focus during this stage.