Phase III trial
Phase III trial
A Phase III trial (pronunciation: /feɪz θriː traɪəl/) is a critical stage in the clinical trial process of new drug development and medical device testing.
Etymology
The term "Phase III trial" originates from the clinical trial design process, which is typically divided into four phases (Phase I, II, III, IV). The "III" signifies the third stage of this process.
Definition
A Phase III trial is designed to assess the effectiveness of a new intervention and its value in clinical practice. It is usually a randomized controlled trial, where the new drug or device is compared with the current standard treatment. The trial involves a large number of participants, often in the thousands, and is conducted at multiple clinical research sites, often across different countries.
Related Terms
- Phase I trial: The first stage in the clinical trial process, primarily concerned with assessing the safety of a new drug or device.
- Phase II trial: The second stage in the clinical trial process, which assesses the efficacy and side effects of the new drug or device.
- Phase IV trial: The post-marketing surveillance trial, which collects information about the drug's effects in various populations and any side effects associated with long-term use.
- Control group: A group of participants in a clinical trial who do not receive the new treatment being tested. The results of the control group are compared with those of the experimental group to assess the effectiveness of the new treatment.
- Experimental group: A group of participants in a clinical trial who receive the new treatment being tested.
External links
- Medical encyclopedia article on Phase III trial
- Wikipedia's article - Phase III trial
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