Phases of Clinical Trials

Phase I trial: The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. Because little is known about the possible risks and benefits of the treatments being tested, Phase I trials usually include only a small number of specific patients.

Phase I/II trial: A trial to study the safety, dosage levels, and response to a new treatment.

Phase II trial: A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

Phase III trial: A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

Phase IV trial: After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.

HCI is constantly working toward improvement in the care of cancer patients and a major focus of the clinical research program is to “personalize” treatment decisions for each cancer patient. 

For more information about active clinical trials at HCI, please go here.