Phase III clinical trial
Phase III Clinical Trial
A Phase III Clinical Trial (pronounced: /feɪz θriː klɪnɪkəl traɪəl/) is a crucial stage in the process of drug development and medical research.
Etymology
The term "Phase III Clinical Trial" is derived from the clinical research process, where it represents the third of four stages in the testing of new treatments or interventions.
Definition
Phase III Clinical Trials are large-scale studies that compare a new therapeutic intervention or drug to the current standard treatment. These trials are designed to confirm the effectiveness of the new treatment, monitor its side effects, and collect information that will allow the intervention or drug to be used safely.
Process
In a Phase III Clinical Trial, the new treatment is tested in a larger group of people (from several hundred to several thousand), often across multiple clinical research sites or hospitals. The trial participants are randomly assigned to receive either the new treatment or the standard treatment. This type of trial is often double-blind, meaning neither the researchers nor the participants know who is receiving the new treatment.
Outcome
The results of Phase III Clinical Trials can influence medical practice and lead to the drug approval by regulatory authorities such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe.
Related Terms
- Phase I Clinical Trial
- Phase II Clinical Trial
- Phase IV Clinical Trial
- Randomized Controlled Trial
- Placebo-Controlled Study
External links
- Medical encyclopedia article on Phase III clinical trial
- Wikipedia's article - Phase III clinical trial
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