Phase III clinical trials
Phase III Clinical Trials
Phase III clinical trials (pronunciation: /feɪz θriː klɪnɪkəl traɪəlz/) are a crucial part of the drug development process and are conducted after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase II clinical trials.
Etymology
The term "Phase III clinical trials" is derived from the sequential nature of clinical trials in drug development. The "III" signifies the third stage in this process.
Definition
Phase III clinical trials are designed to confirm and expand on the effectiveness and monitor the side effects of a new intervention or treatment in large groups of people (from several hundred to several thousand). The trials are randomized and are usually double-blind, meaning neither the patients nor the researchers know who has received the experimental treatment. This phase provides the critical evidence that regulatory authorities review before granting approval for the drug's use in the general population.
Related Terms
- Phase I clinical trials: These are the first stage of testing in human subjects, designed to assess safety, tolerability, pharmacokinetics and pharmacodynamics.
- Phase II clinical trials: The second stage of testing, which assesses drug effectiveness and side effects in a larger group of people.
- Phase IV clinical trials: These are post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.
- Randomized Controlled Trial: A type of scientific experiment that aims to reduce bias when testing a new treatment.
- Double-blind: A type of study in which both the participants and the researchers are unaware of which group is receiving the experimental treatment.
- Drug development: The process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.
External links
- Medical encyclopedia article on Phase III clinical trials
- Wikipedia's article - Phase III clinical trials
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