Phase II trial
Phase II trial
A Phase II trial (pronounced: /feɪz tuː traɪəl/) is a second-stage clinical trial in the process of testing a new drug or treatment. This phase aims to assess the efficacy and side effects of a drug or treatment in a larger group of people than in Phase I trials.
Etymology
The term "Phase II trial" originates from the sequential nature of clinical trials. The clinical trial process is typically divided into four phases (I-IV), with each phase having a distinct purpose and set of objectives. The "II" in "Phase II trial" signifies that it is the second stage in this process.
Related Terms
- Phase I trial: The first stage of clinical trials, primarily concerned with assessing the safety of a new drug or treatment.
- Phase III trial: The third stage of clinical trials, which involves testing the drug or treatment in 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 trial: The post-marketing surveillance trial, which occurs after a drug or treatment has been approved for use by the FDA. This phase involves monitoring drug use in the general population, and also in large numbers of patients over a long period of time.
- Randomized Controlled Trial: 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.
- Placebo: A substance that has no therapeutic effect, used as a control in testing new drugs.
External links
- Medical encyclopedia article on Phase II trial
- Wikipedia's article - Phase II trial
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