Which of the following best describes Phase 3 of FDA clinical trials?

Question

BlackTom AI · Accepted Answer

Let's break down what Phase 3 of FDA clinical trials entails and then evaluate each option against that purpose.

Option a) 'Determine which dose works the best for the drug' — This is primarily a dose-ranging activity that is typically associated with Phase 2 trials, where multiple doses are tested to identify the optimal dose. Phase 3 is not primarily focused on dose selection, but on confirming efficacy and safety of the chosen dose(s) in a larger population. Therefore, this statement misattributes the main Phase 3 goal.

Option b) 'Gather information about how the drug interacts with the human body' — This describes pharmacokinetics and pharmacodynamics, a domain more characteristic of Phase 1 studies (early human trials) and early Phase 2, where absorption, distribution, metabolism, and excretion are assessed. Phase 3 does not primarily aim to gather new PK/PD data; it assumes prior understanding and focuses on confirming efficacy and safety in a broader cohort. Hence this option is not aligned with Phase 3.

Option c) 'Confirm effectiveness of the drug, while continually monitoring safety' — This statement directly captures the core objective of Phase 3. In large-scale trials, the drug’s efficacy is confirmed in diverse patient populations, and ongoing safety monitoring detects adverse events and risk signals, informing a risk-benefit assessment. This is the best description of Phase 3.

Option d) 'Gather information on the drug's effect in various populations as well as any long-term side effects post-use' — While Phase 3 may include some diversity in populations, the detailed long-term post-use surveillance and effects are typically pursued in Phase 4 (post-marketing) studies after approval, not during Phase 3. Phase 3 focuses on confirming efficacy and safety before regulatory submission, with less emphasis on long-term post-marketing data collection.

In summary, when aligning each option with the canonical objectives of Phase 3, option c accurately describes Phase 3’s primary aim, whereas options a, b, and d reflect activities more characteristic of Phase 2 and Phase 1 or Phase 4, respectively.

Which of the following best describes Phase 3 of FDA clinical trials?

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