Oncology Certified Nurse (OCN) Nursing Practice Test

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What best describes the population involved in a Phase 3 clinical trial?

  1. Small numbers of patients with uniform responses

  2. 100-1000's of diverse participants with various cancers

  3. Limited patients with the same type of cancer

  4. Patients with advanced disease only

The correct answer is: 100-1000's of diverse participants with various cancers

Phase 3 clinical trials are designed to evaluate the effectiveness and safety of a treatment in a larger population before it can be approved for general use. This phase typically involves hundreds to thousands of participants to gather substantial data that can support the efficacy of the intervention across a diverse range of demographics, cancer types, and stages of disease. In these trials, it’s important to include a broad participant base to assess how different patient characteristics, such as age, sex, ethnicity, and comorbidities, affect treatment outcomes. The inclusion of various cancers among the participants allows researchers to understand the effects of the treatment across different tumor types and to identify any varying responses that may occur due to biological differences among cancers. This approach enhances the generalizability of the trial results, ensuring that they are applicable to a wider patient population upon drug approval. Thus, the diversity in the study population is a critical element of Phase 3 trials, making the characterization of participants as "100-1000's of diverse participants with various cancers" accurate.