Question:
Which phase of clinical trials is typically double-blind, randomized and conducted in a heterogeneous patient population across multiple centers?
Which phase of clinical trials is typically double-blind, randomized and conducted in a heterogeneous patient population across multiple centers?
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Clinical trials proceed in phases, each with a different size, purpose and design. Knowing the defining features of each phase is important for both regulatory and pharmacology questions.
Updated On: Jun 24, 2026
- Phase II
- Phase III
- Phase IV
- Phase 0
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The Correct Option is B
Solution and Explanation
Concept:
Clinical trials proceed in phases, each with a different size, purpose and design. Knowing the defining features of each phase is important for both regulatory and pharmacology questions.
Step 1: Phase III trials are large, randomized, double-blind, controlled studies carried out in a large and heterogeneous patient population across multiple centres. Their goal is to confirm efficacy and monitor adverse effects before marketing approval.
Why the other choices are wrong: Phase II studies are smaller, focused on efficacy and dosing in a more limited patient group. Phase IV is post-marketing surveillance after approval. Phase 0 involves micro-doses in very few volunteers for early pharmacokinetic data.
Answer: Option (2) — Phase III trials are the large, multicentre, randomized double-blind studies. (2)
Clinical trials proceed in phases, each with a different size, purpose and design. Knowing the defining features of each phase is important for both regulatory and pharmacology questions.
Step 1: Phase III trials are large, randomized, double-blind, controlled studies carried out in a large and heterogeneous patient population across multiple centres. Their goal is to confirm efficacy and monitor adverse effects before marketing approval.
Why the other choices are wrong: Phase II studies are smaller, focused on efficacy and dosing in a more limited patient group. Phase IV is post-marketing surveillance after approval. Phase 0 involves micro-doses in very few volunteers for early pharmacokinetic data.
Answer: Option (2) — Phase III trials are the large, multicentre, randomized double-blind studies. (2)
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