Massachusetts Pharmacy Technician License Practice Test

In which phase of the FDA new drug application do double-blind, placebo-controlled trials occur?

1. Phase 1

2. Phase 2

3. Phase 3

4. Phase 4

The correct answer is: Phase 3

The correct answer is based on the fact that Phase 3 of the FDA new drug application process is specifically designed to provide more definitive evidence of a drug's efficacy and safety. During this phase, large-scale trials are conducted using double-blind, placebo-controlled designs. This means that neither the participants nor the researchers know who is receiving the treatment and who is receiving a placebo, which helps to eliminate bias and allows for a clearer assessment of how the drug performs compared to no treatment. Phase 3 trials typically involve thousands of participants and are critical for evaluating the drug's effects across a diverse population. The information gathered during this phase is essential for the FDA’s decision-making process regarding the drug's approval for market use. In contrast, earlier phases focus more on safety and dosage (Phase 1) and further efficacy testing with a smaller group (Phase 2) but do not utilize the same robust methodology as Phase 3 trials. Phase 4 occurs after a drug has been approved and involves post-marketing surveillance to monitor long-term effects and safety in the general population. Thus, the emphasis on rigorous trial design in Phase 3 makes it the correct phase associated with double-blind, placebo-controlled trials.