FAQs

While the following may not answer all of your questions, they are great resources and address the common questions that the Clearview research team receives from patients. A list of questions that you might want to ask yourself, your doctor, or a person from the study team, is also included.

WHAT IS A CLINICAL TRIAL?

Clinical trials offer patients opportunities to receive promising, new treatments (called investigational new drugs or INDs) that are not available for general use. In cancer research, clinical trials look for:

DO I HAVE TO SIGN UP FOR A CLINICAL TRIAL?

Taking part in a clinical trial is voluntary. If you decide to take part in a trial and then change your mind, you may drop out of the trial at any time. Whatever decision you make, your physician and treatment team will assure you get the best care for your disease.

WHAT ARE THE PHASES OF CLINICAL TRIALS?

Clinical trials have 4 phases. Each phase is designed to learn specific information, but patient safety is the primary goal of any clinical trial.

Phase I - How much of a new treatment can safely be given to a patient?

Phase I studies aim to find the safest dose of an investigational drug that is effective in humans and to see how the treatment affects the human body.

Phase IIDoes the new treatment work in a specific type of cancer?

Phase II studies assess the safety of an established dose in a larger number of patients and determine if an investigational treatment has an effect on a certain type of cancer.

Phase IIIIs the new treatment better than current treatment for a specific type of cancer?

Or, does the new treatment improve outcomes when added to current treatment for a specific type of cancer? Phase III studies assess the safety of an investigational agent and its effectiveness to the current, standard treatment.

Phase IVWhat are the long-term side effects of a drug?

Phase IV studies assess the safety of a drug after it is an FDA-approved therapy (sometimes called post-market research).

WHAT MIGHT HELP YOU DECIDE IF ENTERING A CLINICAL TRIAL IS RIGHT FOR YOU?

Understand your choices.

Find out what the study involves and any other options that are available to you. Useful resources include:


Bring a trusted family member or friend with you when you meet with your CCI physician to discuss treatment options, including a clinical trial. You may want to include that person on your HIPAA release. That person can:

QUESTIONS YOU MIGHT ASK YOURSELF

QUESTIONS YOU MIGHT ASK THE STUDY COORDINATOR

A study coordinator from the CCI Research Team will meet with you regarding clinical trials at CCI that you or your doctor think would be great treatment options for you. Each trial is unique but common questions that you may want to ask about a clinical trial are below.

What should I know about the study?

What financial issues I should consider?

How will my health care study team follow my care?

How will the study affect my overall health care?

Where will I be treated if I participate in the study?

What happens if I withdraw from the study?

HOW ARE PATIENTS PROTECTED WHILE ON A CLINICAL TRIAL?

A clinical trial cannot start until a group of people called the Institutional Review Board (IRB) has reviewed the protocol. The IRB must be satisfied that the trial:

While the study is going on, the IRB receives regular updates to make sure the study is being carried out as planned and that any safety issues are addressed promptly. The U.S. Food and Drug Administration (FDA) or the National Cancer Institute (NCI) may also review the study .A patient must meet certain requirements to take part in a clinical trial. The CCI Research Team and your CCI doctor will review your information and the clinical trial requirements. If your risk from being in the trial is greater than any possible benefit, you might not be able to join the study.

During a study, we will try to identify any potential side effects as quickly as possible.