FPGEE for National Association of Boards of Pharmacy (NABP) Practice Exam

Which phase of the IND process involves a double-blind study?

1. Phase I

2. Phase II

3. Phase III

4. Phase IV

The correct answer is: Phase III

The phase of the Investigational New Drug (IND) process that involves a double-blind study is Phase III. This phase is critical in the drug development process, as it includes large-scale studies that are designed to assess the efficacy of a drug in comparison to a placebo or standard treatment. In a double-blind study, neither the participants nor the researchers know who receives the experimental treatment and who receives the control. This approach helps eliminate bias in the results, ensuring that the outcomes are due to the drug itself rather than expectations or preferences from either the subjects or the researchers. This phase typically involves a diverse population and evaluates both the effectiveness and the continued safety of the drug in a more comprehensive manner. Other phases, such as Phase I and Phase II, primarily focus on safety and dosage, often with smaller participant groups, and do not typically employ a double-blind design to the same extent. Phase IV occurs after drug approval, focusing on post-marketing surveillance and may utilize different study designs. Therefore, Phase III is the correct phase associated with double-blind studies in the IND process.