SOCRA CCRP Practice Exam

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What is the primary intention of a Phase II trial?

To conduct post-marketing surveillance
To test the drug's efficacy and safety in a small group of volunteers
To compare the new drug against standard of care or placebo
To conduct large-scale studies for final confirmation of efficacy and monitoring of adverse reactions

The correct answer is: To compare the new drug against standard of care or placebo

A Phase II trial is primarily intended to test the new drug against standard of care or placebo to evaluate its effectiveness and safety in a small group of volunteers. Option A is incorrect because post-marketing surveillance usually takes place after a drug has been approved and is on the market. Option B is incorrect because while testing efficacy and safety is a goal of a Phase II trial, it is not the primary intention. Option D is incorrect because large-scale studies for final confirmation of efficacy and monitoring of adverse reactions occur in Phase III trials, not Phase II. Option C is the most accurate option as it specifically addresses the primary intention of a Phase II trial.