What is a Phase 3 study?
A study that tests the safety and how well a new treatment works compared with a standard treatment. For example, phase III clinical trials may compare which group of patients has better survival rates or fewer side effects. Phase III clinical trials may include hundreds of people. Also called phase 3 clinical trial.
What is a first in human study?
HYOO-mun STUH-dee) A type of clinical trial in which a new drug, procedure, or treatment is tested in humans for the first time. First-in-human studies take place after the new treatment has been tested in laboratory and animal studies and are usually done as phase I clinical trials.
What is a Phase 4 study?
A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. Phase IV clinical trials may include thousands of people. Also called phase 4 clinical trial and post-marketing surveillance trial.
What is a Phase 2 3 study?
A study that tests how well a new treatment works for a certain type of cancer or other disease and compares the new treatment with a standard treatment. Phase 2/phase 3 clinical trials may also provide more information about the safety and side effects of the new treatment. Also called phase II/III clinical trial.
Is first in human the same as Phase 1?
In general, all “first in human” trials are phase 1 clinical trials. However, not all phase 1 trials are “first in human” since a drug is normally tested in more than one phase 1 study. In other words, the “first in human” concept refers to the very first trial in which a drug is evaluated in patients.
What is FIH study?
A type of clinical trial in which a new drug, procedure, or treatment is tested in humans for the first time. FIH studies take place after the new treatment has been tested in laboratory and animal studies and are usually done as phase I clinical trials. Also called first-in-human study.
What is the purpose of Phase 4 study?
The main objective of the phase 4 trial is to check the drug’s performance in real life scenarios, to study the long-term risks and benefits of using the drug and to discover any rare side effects.