| phase II trial |
A study designed to get more information about a new drug's safety and how effective the drug may be. These trials may include 20-40 patients over a couple of years. A higher level of response must be seen to move the drug into phase III trials (see below).
출처: saci.uthscsa.edu/PatientServices/glossary.html
|
|---|---|
| phase III trial |
A study that compares a new treatment to the current standard of care. The study is designed to look for various results, such as 1) the new drug or method of giving the drug may be more effective, or 2) it may be as effective but safer, or 3) it may be somewhat less effective but less toxic and less expensive, or 4) it can be given over a shorter period of time and/or on an easier schedule. ...
출처: saci.uthscsa.edu/PatientServices/glossary.html
|
| phase IV trial |
This type of study is used to confirm the results of a phase III study in the general population, so it is usually involves large community groups and looks for any differences in how it works in people of different ages, gender, race, etc.
출처: saci.uthscsa.edu/PatientServices/glossary.html
|
| phase I trial |
Includes initial introduction of an investigational new drug into humans. These studies typically involve seriously ill patients for whom no effective standard therapies are available. Phase I trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness; they are typically closely monitored. ...
출처: www.umich.edu/~newsinfo/Releases/2001/Aug01/glossa...
|
| phase II trial |
Includes controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug.
출처: www.umich.edu/~newsinfo/Releases/2001/Aug01/glossa...
|