Phase II
Phase II
Phase II (pronounced: /feɪz tuː/) is a term commonly used in clinical trials to refer to the second stage of testing for new drugs or treatments.
Etymology
The term "Phase II" comes from the sequential nature of clinical trials, where each phase represents a different stage of testing. The term is derived from the Latin phasus, meaning "stage" or "phase", and the Roman numeral II, signifying the second stage.
Definition
In clinical research, Phase II trials are designed to assess the effectiveness and side effects of a new intervention or treatment in a larger group of people (typically 100-300). These trials are often randomized and controlled, and are used to determine the optimal dose and schedule for the new treatment.
Related Terms
- Phase I: The first stage of clinical trials, where a new drug or treatment is tested in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase III: The third stage of clinical trials, where the new drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: The post-marketing surveillance trial, after the drug or treatment has been approved and is on the market. These trials are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
- Randomized Controlled Trial (RCT): A type of scientific experiment that aims to reduce bias when testing a new treatment. The people participating in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment (or placebo treatment) as the control.
External links
- Medical encyclopedia article on Phase II
- Wikipedia's article - Phase II
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