Phase I / Early Phase Clinical Trials

What are Phase I clinical trials?

The purpose of Phase I trials is to determine a safe dose of the treatment. Phase I studies also help us see how the drug affects the body. These studies may include newly developed drugs or new combinations of existing therapies.

Phase I studies usually include a small number of people, often with different types of cancer. Our team watches participants closely to make sure they are safe and that we get the data needed to evaluate the treatment.

Although some patients might benefit from the new therapy, the main goal of the study is to check for serious side effects. Inactive treatments, or placebos, are rarely used in Phase I trials.

What are Phase II clinical trials?

Once studies show a new drug or therapy is safe, a Phase II clinical trial is done to confirm its safety in a larger group of people. Phase II trials also see how well the treatment works in certain types of cancer. Patients in these trials receive the dose or combination found to be safest and most effective during earlier studies. We may collect blood and tissue samples to help us learn more about how the treatment fights cancer.

Some clinical trials begin as Phase I and move into Phase II once a safe dose is found. If this is the case for a study you are considering, our team will let you know which portion of the trial is open.

What kinds of drugs are available through clinical trials?

The clinical trials at HCI use a variety of treatments, including some designed to help your immune system fight cancer and others that target specific genetic changes in tumors. Depending on your cancer and the treatment you have already received, you may get the new therapy on its own or along with standard treatments like chemotherapy or hormone therapy.

Other clinical trials look at new ways of doing surgery or radiation to see if they are more effective or have fewer side effects. Your doctors and clinical research team will let you know about the possible benefits of each treatment, as well as any known risks, before you start.

Who pays for a clinical trial?

When you take part in a clinical trial, much of the care is the same as if you were receiving a standard treatment. You will continue to see a doctor, have regular lab tests, and undergo CT scans or other imaging. Health insurance often covers these costs, along with the cost of any approved treatments that you receive during the trial.

We may do extra tests and procedures throughout the trial to ensure your safety and gather important information about the new treatment. These research costs are not usually covered by insurance, but may be paid for by the study sponsor.

Your doctor or clinical research coordinator will make sure to talk to you about costs and answer your questions before you begin treatment. You can also speak with HCI’s financial advocates about insurance or billing concerns.

How long do patients stay on a clinical trial?

It depends on the study. You may get a specific number of treatments, or you may stay on the new therapy as long as it is working and you are not having severe side effects. Almost all clinical trials include regular lab tests or imaging.

Taking part in a clinical trial is always your choice. You can tell your doctor if you want to stop at any time for any reason. You should also tell your health care team if you have any side effects from the trial treatment. They can treat your symptoms and make sure it is safe for you to continue treatment.