Which of the Following Best Describes a Phase II Trial

question 120

Multiple Choice

Which of the following best describes a phase II trial?

• A) Relatively small randomized, blinded trial that tests tolerability and different intensity or dose of the intervention on surrogate or clinical outcomes
• B) Studies involving animals or cell cultures
• C) Relatively large randomized, blinded trial used to evaluate the efficacy of an intervention
• D) An unblinded and uncontrolled study involving a few volunteers to test the safety of an intervention
• E) Large studies (may or may not be a randomized trial) conducted after the therapy has been approved by the FDA to assess the rate of serious side effects and explore further therapeutic uses

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