Cancer Clinical Trials FAQ - Decision-Making Information

Here are the answers to common questions that arise when considering participation in a clinical trial:

To help answer any questions you may have as you consider a clinical trial, please see the frequently asked questions below.

What are clinical trials?

Clinical trials explore how new cancer drugs, treatments, diagnostic procedures and therapies work on people. They're important because:

  • Patients who participate may be helped by the treatment they receive. Trial participants 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 dosage.
    • Phase II: Continue to test the safety of the drug and begin 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: These studies are done after the drug or treatment has been marketed. These studies continue testing the drug or treatment to collect information about its side effects.

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What exactly is a placebo, and do cancer patients ever receive placebos 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 are 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 are my rights and responsibilities while participating in a clinical trial?

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

  • 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 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, healthcare institutions, and 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.

Getting Started

Contact us and schedule a consultation with a nurse navigator who specializes in clinical trials:

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