Question

To monitor the safety of the new drug under actual conditions of use in large number of patients has been classified as____ clinical trials.

• A. Phase III
• B. Phase II
• C. Phase IV
• D. Phase I

Answer 1

The Correct Option is C

The question asks about the classification of clinical trials that monitor the safety of a new drug under actual conditions of use in a large number of patients. Understanding the phases of clinical trials is crucial in answering this question correctly. Here's a breakdown of the different phases:

1. Phase I: These trials primarily focus on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug. They are conducted with a small number of healthy volunteers or patients.
2. Phase II: Phase II trials aim to evaluate the efficacy of a drug while continuing to assess its safety. These are controlled trials conducted with a larger group of patients who have the target disease or condition.
3. Phase III: This phase involves randomized and blind testing in several hundred to several thousand patients. It aims to confirm the effectiveness, monitor side effects, and collect information that will allow the drug to be used safely. These trials are crucial before the drug is approved for general use.
4. Phase IV: These are post-marketing studies that monitor the drug's effect in various populations and any side effects associated with long-term use. Phase IV trials gather additional information including the drug's risks, benefits, and optimal use.

Based on this classification, Phase IV clinical trials are correct for monitoring the safety of a new drug under actual conditions of use in a large number of patients. This phase allows for the observation of any adverse effects that may occur in a broader patient population over a longer time period.

Correct Answer: Phase IV