Practice Quiz

FPGEE Foreign Pharmacy

Category - Clinical

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Which of the following is likely to be true of a Phase I clinical trial?
  1. A Phase I clinical trial may be a retrospective trial of 2000 patients.
  2. A Phase I clinical trial is often opened to a small group of people with a number of different types of cancer.
  3. A Phase I clinical trial involves many clinical centers and large numbers of patients.
  4. A Phase I clinical trial is only completed when every patient is cured.
Explanation
Answer: B − Phase I clinical trials are most often done with small groups of patients with a variety of diseases or cancers-the main thrust of a Phase I clinical trial is to determine the safe dose range of an agent and if there is a rationale to continue testing and main side effects. Phase I clinical trials are not retrospective (historic) in nature.
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