Cancer clinical trials

What exactly is a clinical trial?

A clinical trial explores how new cancer drugs, treatments, diagnostic procedures and therapies work on people. Clinical trials are important because:

• You may be helped by the treatment you receive. You have access to the latest drugs, procedures and other types of treatment sometimes five to 10 years before they're FDA approved. Although there's no guarantee that a new treatment will be effective, many trial participants conclude that the possible benefits outweigh the risks.
• Clinical trials are usually conducted in four phases, each one designed to build on the knowledge gained in the one before.
  • Phase I: Evaluates how a new drug should be given (by mouth, injection into the blood or into the muscle), how often it should be taken and what amount constitutes a safe dose.
  • Phase II: Continues to test the safety of the drug and begins to evaluate how well the new drug works on a particular kind of cancer.
  • Phase III: Compares the results of people taking the new drug with the results of those taking the standard treatment.
  • Phase IV: Continues testing the drug or treatment after it has been marketed. These studies continue testing the drug or treatment to collect information about its side effects.

During a clinical trial, you'll:

• Be closely monitored by the study coordinator and physician
• Learn more about your disease or condition and the latest advances in treatment
• Contribute to the advancement of medical care

Who's eligible for a clinical trial?

A clinical trial is an option at any stage of your cancer journey. In fact, it's recommended that you seek out a clinical trial as soon as you're diagnosed. You don't have to wait until other treatments have failed to enroll in a trial.

Each clinical trial has specific eligibility requirements you must meet before you can participate. An HonorHealth Research Institute nurse navigator will help you make a decision.

Who pays for a clinical trial?

• The clinical trial sponsor (whether it's the government or a company) may pay for the experimental treatment, special testing and extra doctor visits.
• Some health insurance companies will cover the costs of procedures that patients would have even if they were not in a clinical trial (routine costs that are considered the "standard of care"). For Medicare patients, routine costs are covered in all Medicare-qualified clinical trials.
• You'll be responsible for any costs not covered by the clinical trial sponsor or your health insurance company. A nurse navigator can help you understand more about which costs will be your responsibility if you decide to participate in a clinical trial.

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What's a placebo, and do you ever receive one in a clinical trial?

A placebo is a substance that looks like medicine but is not. Cancer patients in a clinical trial always receive the best standard treatment available or a new treatment that researchers believe is as good or better.

Only in specific circumstances are cancer patients given placebos in a randomized trial. If a placebo is used, researchers may give patients in the control group a placebo in combination with standard treatment to compare standard treatment alone to standard treatment with a new drug.

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What are the risks of participating in a clinical trial?

Talk with your doctor about some of the risks involved with treatment. For example:

• New drugs or treatments may not be better than the standard care with which they're being compared
• New treatments may have unexpected side effects and may be worse than those of standard treatments
• You may be required to make more frequent visits to the doctor

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What should I ask my doctor about clinical trials?

Have an open, honest conversation with your doctor about your options. You may want to ask such questions as:

• What are the possible immediate and long-term side effects?
• What other treatment options do I have?
• Will I have to pay anything to participate in the study? If so, what are the charges likely to be?

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What are my rights and responsibilities while participating in a clinical trial?

Participation in clinical trials is optional. Likewise, you may choose to leave a clinical trial at any time. If you plan to stop participating, let the research team know why you're leaving the study.

Before entering a cancer clinical trial, you should know as much as possible about the research study. It's important to ask questions and get answers in language you understand.

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Who sponsors clinical trials?

Clinical trials can be sponsored by government agencies, pharmaceutical companies, individual physician-investigators and healthcare institutions. Clinical trials also can be sponsored by universities, organizations that develop medical devices, doctor's offices or community clinics.

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Who regulates clinical trials?

The U.S. government has strict guidelines and safeguards to protect individuals who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by a local Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.

An IRB is an independent committee of physicians, statisticians, community advocates and others who ensure that a clinical trial is ethical and that the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

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