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:

• New ways to detect, treat, and prevent cancers
• Improved management of side effects from disease or treatment
• A better understanding of disease and treatment on a patient’s quality of life

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 a clinical trial?

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 II – Does 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 III – Is 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 IV – What 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:

• A member of the CCI Research Team (usually a study coordinator) will meet with you to discuss a clinical trial in detail and provide you the study information (informed consent). You will have the opportunity to review the information and have all of your questions answered, to your satisfaction, before you make your decision regarding participation in a clinical trial.
• Your personal contacts
• A support group
• National organizations such as:
  • National Cancer Institute (NCI)
  • American Cancer Society (ACS)
  • National Coalition for Cancer Survivorship

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:

• Ask questions
• Write down the study team’s answers
• Discuss the pros and cons of the study with you after the doctor’s visit

Questions you might ask yourself:

• Each person is unique and what feels right to someone else might not feel right to you. When it comes to participation in a clinical trial, you should make a decision based on your own personal feelings and needs.
• Do I feel comfortable receiving a treatment whose risks and benefits are somewhat unknown?
• How do the side effects of the study treatment differ from my standard of care treatment options?
• Would any of the possible side effects from receiving the study drug relative to standard of care treatment be unsatisfactory to me?
• If I have exhausted all other treatment options, would I rather receive treatment on a clinical trial with some unknowns or receive hospice care, aimed at helping me live comfortably and to stay at home?
• Am I satisfied that my decision is right for me, and not a decision that is being made to please someone else?

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?

• Why is the study being done?
• Have there been other studies that evaluated this drug? If so, what were the results?
• Is it possible that I will be treated with an inactive substance (placebo) if I participate in the study?

What financial issues I should consider?

• Will my insurance company pay for any extra costs of participating in the trial?
• If I don’t have insurance, can I still be in the study?

How will my health care study team follow my care?

• Who are the health care professionals who will take care of me during the study?
• If I withdraw from the study or if I change studies, will my health care team change?
• When the study is over, will the same doctors and nurses take care of me?

How will the study affect my overall health care?

• How are the study treatments and procedures different than the regular medical care that I might get if I decide not to take part?
• Can I take my regular medications while I am in the study?
• If I enroll in the study, will I be able to find out my test results?
• If someone else in the study has an unexpected and severe health problem, will I be told?
• If I think the new treatment worked for me, will I be able to get the same treatment after the study ends?
• Will I need to keep getting tests done after I stop taking the study drug?

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 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:

• Addresses an important scientific question
• Is well planned
• Ensures patient safety
• Is ethically sound

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.

• We may do more tests and physical exams than if someone were not taking part in a clinical trial.
• If you develop unexpected health problems will on a clinical trial, you would notify us immediately for prompt treatment.

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