Chemotherapy Biotherapy Certification ONS Practice Testq

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What does Phase 2 of a clinical trial primarily determine?

  1. Safety of the treatment

  2. Drug activity and response rate

  3. Long-term effectiveness

  4. Survival rate and quality of life

The correct answer is: Drug activity and response rate

Phase 2 of a clinical trial primarily focuses on assessing the activity of a drug and determining the response rate in patients with a particular disease, typically the condition that the drug is aimed to treat. During this phase, researchers evaluate how well the treatment works and its effectiveness against the disease, often measuring biomarkers or other indicators of response. This phase is crucial for identifying the potential therapeutic benefit of the drug and may involve the collection of data on the appropriate dosage level. While safety is also monitored during Phase 2, it is the activity and efficacy of the drug that are the primary concerns. Long-term effectiveness, survival rates, and quality of life are generally evaluated in later phases of clinical trials, such as Phase 3, when a larger patient population is studied over an extended period. Therefore, the emphasis on drug activity and response rate makes the answer regarding Phase 2 correct.