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. Personalized or precision medicine is a medical model that proposes the customization of healthcare with medical decisions and treatments being tailored to the individual patient.

The use of genetic information, as well as information about a patient’s tumor, has played a major role in personalized medicine. For example, the CIT has integrated tumor genomic screening and molecular imaging into our early phase clinical trials as a way to individualize choice of therapy and to assess response to treatment.

HCI currently uses a novel decision analysis protocol that integrates genomic screening for patients with metastatic solid tumors in a new trial where a 360 gene mutation panel is analyzed.

Please visit the Huntsman Cancer Institute website to learn more about clinical trial research and participating in clinical trials.