Clinical Trials Phases

Question 1

Phase 0 Trials Purpose

Answer 1

Very small rare trials that help researchers decide if a new drug should be tested in a phase 1 trial.

Question 2

Phase 1 Trials Purpose

Answer 2

To find a safe dose.
To decide how the new treatment should be given.
To see how the new treatment affects human body and fights cancer.
Number of people taking part is small (less than 80).

Question 3

Phase 2 Trials Purpose

Answer 3

To determine if the new treatment has an effect on a certain cancer.
To see how the new treatment affects the body and fights cancer.
Number of people taking part is less than 100.

Question 4

Phase 3 Trials Purpose

Answer 4

To compare the new treatment (or use of treatment) with the current standard treatment.
Number of people taking part is from 100 to several thousand.

Question 5

Phase 4 Trials Purpose

Answer 5

These trials are rare.
Look at long term safety and effectiveness.
They take place after a new treatment has been approved and is on the market.