Phase II clinical trial
Phase II Clinical Trial
A Phase II Clinical Trial (pronounced: /feɪz tuː klɪnɪkəl traɪəl/) is a second-stage study in the process of clinical trials conducted to assess the effectiveness and side effects of a new drug or therapy.
Etymology
The term "Phase II Clinical Trial" is derived from the clinical research terminology where "Phase II" signifies the second stage of testing in the development of a new treatment.
Definition
A Phase II Clinical Trial is a study that tests the efficacy of a new intervention in a larger group of people (usually 100-300) who have the condition the intervention is intended to treat. These trials also continue to study safety, including short-term side effects. This phase can last several years.
Related Terms
- Phase I Clinical Trial: The first stage of testing in human subjects, designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.
- Phase III Clinical Trial: The third stage of testing, designed to assess the effectiveness of the new intervention and its value in clinical practice.
- Phase IV Clinical Trial: Post-marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
See Also
External links
- Medical encyclopedia article on Phase II clinical trial
- Wikipedia's article - Phase II clinical trial
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