Clinical Study Search
A new treatment goes through several phases. Each phase has a different purpose:
- Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Doctors also look for signs that cancer responds to the new treatment.
- Phase II trials test if one type of cancer responds to the new treatment.
- Phase III trials test if a new treatment is better than a standard treatment.
- Phase IV trials find more information about long-term benefits and side effects.
Studies: Phase I
Test if a new treatment is safe in people. Doctors also find the best way to give the treatment.
Phase I trials usually include 15 to 50 patients who are divided into small groups called cohorts.
If the doctors find that the treatment is safe, then it will move forward to be studied in a Phase II trial.
Studies: Phase II
Test if a new treatment works for a single condition.
Fewer than 100 patients usually join a Phase II trial. Even though the main goal is to see if the treatment works, doctors still closely watch patients’ side effects. If the new treatment works, doctors may go on to study it in a Phase III trial.
Studies: Phase III
Test if a new treatment is better than standard treatment.
Phase III trials may include hundreds to thousands of patients around the country or world. After the Phase III trial, the FDA reviews the clinical trial results to make sure the treatment is safe and effective for people to use. The FDA decides whether to approve the treatment so that it is available for all patients.
Studies: Phase IV
Research to find more information about long-term side effects.
In Phase IV trials, doctors study treatments that the FDA has already approved. The goal of Phase IV trials is to continue studying side effects of a new treatment.
