Phase III

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Phase III

Phase III (pronounced: /feɪz θri:/) is a term commonly used in clinical trials to describe the third stage of testing for new drugs or medical treatments.

Etymology

The term "Phase III" originates from the Food and Drug Administration (FDA)'s process of drug approval. It is the third of four phases in clinical trials, following Phase I and Phase II, and preceding Phase IV.

Definition

In Phase III of a clinical trial, the drug or treatment is tested in larger groups of people (from several hundred to several thousand), to confirm its efficacy, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Related Terms

  • Clinical trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
  • Efficacy: The ability to produce a desired or intended result.
  • Food and Drug Administration (FDA): The federal agency responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed, and veterinary products.
  • Phase I: The first stage of clinical trials, where researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II: The second stage of clinical trials, where the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase IV: The fourth and final stage of clinical trials, occurring after FDA has approved a drug. This phase involves the ongoing collection of data to monitor the drug's effectiveness in the general population and to collect information about any side effects associated with widespread use.

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