Question

What is not correct about the different phases of clinical trials?

-"In Phase III of clinical trials, the safety and efficacy of the drug is normally tested in a large group of individuals (up to several thousands) who have the condition being treated."
-Phase III of clinical trials is also known as entry-into-man studies
-"In Phase I clinical trials, the safety or toxicity of the drug is mainly tested in a small group of normally healthy individuals"
-A phase IV study is often conducted to demonstrate possible superiority against a competitor drug
-"In Phase II of clinical trials, the efficacy and safety of the investigational drug is normally first tested in individuals (up to a few hundreds) who have the condition being treated."

Answer 1

The incorrect statement about clinical trials is that Phase III is known as 'entry-into-man' studies, which actually refers to Phase I. Phase III evaluates the safety and efficacy of a drug in a large patient population, while Phase IV includes post-marketing surveillance and comparisons. The correct option is 2.

Step-by-step explanation:

Regarding the different phases of clinical trials, the incorrect statement is: "Phase III of clinical trials is also known as entry-into-man studies." This is not accurate because Phase III is indeed about testing the safety and efficacy of a drug in a large population, but the term 'entry-into-man' is associated with Phase I clinical trials.

The primary goal of Phase I is to evaluate the safety or toxicity of a drug in a small group of healthy individuals, identifying safe dosage ranges, and assessing pharmacokinetic profiles.

During Phase II, the efficacy and safety are further evaluated in a larger group of individuals with the condition being treated. It is in Phase IV, post-marketing studies, where a drug's performance may be compared to competitors, and where long-term efficacy and additional safety data are gathered. Option 2. is the correct one.