| I |
15 to 30 people |
- To find the safe maximum tolerated dose (MTD)
- To decide how the treatment should be given (eg, orally or intravenously)?
- To observe how the treatment affects the human body
|
| II |
Less than 100 people |
- Uses the maximum tolerated dose (MTD) established during Phase I
- To determine if the treatment has an effect on a particular stage of cancer
- To see how the treatment affects the human body
|
| III |
From 100 to 1,000 people |
- To compare a new agent or intervention (or new use of a treatment) with the current standard of care
|
| IV |
Several hundred to several thousand people |
- To further evaluate the long-term safety and effectiveness of a new treatment in the “real world
|
