Patient Safety in Clinical Trials

Approved by the Cancer.Net Editorial Board, 08/2017

Watch the Cancer.Net Video: Clinical Trials and Safety with Eric Singer, MD, MA, adapted from this content.

Patient safety is the top concern in clinical trials. That’s why every research study must follow a strict review and oversight process.

Who makes rules for clinical trials?

Clinical trial doctors and staff must follow rules from several groups of experts. These rules are made to keep you and other volunteers as safe as possible in the clinical trial. Below are the 3 main groups of experts that make rules for clinical trials in the United States.

  • Institutional Review Board (IRB). An IRB is a committee of experts that makes sure a clinical trial is designed correctly, safe, and fair. It protects the rights and welfare of clinical trial volunteers. An IRB must approve and monitor any clinical trial that involves people. The IRB does most of its work before a clinical trial starts. When the board has all the information it needs, it approves the clinical trial for doctors to start it.

  • Government organizations. In the United States, the Food and Drug Administration (FDA) makes rules for clinical trials. The National Institutes of Health also checks clinical trials.

  • Data and Safety Monitoring Board (DSMB). A DSMB is made up of clinical trial experts who check on how each clinical trial is going. They make sure the clinical trial is safe for volunteers and that doctors are learning valuable information from it. A DSMB checks what goes on during a clinical trial. Then they tell the organization that started the clinical trial if they think it should change, stop, or continue the clinical trial.

Who helps me understand the clinical trial before I join it?

The research team helps you understand the clinical trial before you decide whether to join it. They give you an “informed consent” form that tells you what happens in the study. It explains your options, including not being in the study, and describes the possible risks and benefits of being in the clinical trial.

Your doctor and/or the study’s research team will talk with you about the informed consent form and answer questions. They will talk with you about:

  • All your treatment options, including your choices if you decide not to join the clinical trial.

  • The clinical trial treatment, including how it is different from the standard treatment and why doctors are studying it.

  • The possible risks and benefits of the clinical trial treatment. These might be different from the possible risks and benefits of the standard treatment. Or, they might be similar.

  • What you need to do if you join the clinical trial. You will learn about the:

    • Number of doctor visits and medical tests

    • Treatment schedule

    • Right to leave the study at any time

    • Possible cost to you

    • Ways the clinical trial staff protect your privacy and personal information

    • Contact information for the clinical trial staff for any questions or concerns

You might also want to talk about the consent form with family members or friends. If you join the clinical trial, you will get a signed copy to keep with your personal medical records.

Informed consent does not end when you sign the form. The clinical trial staff wants to hear your questions and address your concerns at any time. They also want to give you any new information about the clinical trial or treatment.

Can I leave a clinical trial?

Yes. You can leave at any time, for personal or medical reasons. You will still get the standard treatments and medical care you need if you leave.

What if the cancer gets worse?

Just like standard cancer treatments, clinical trials do not always help. If the cancer gets worse, you can choose to leave the clinical trial or stay in it. You can have standard treatment or stop treatment if you want. You will probably want to talk with your doctor, family members, and friends. You might also want to talk with the research team about your choices.

What if I have severe side effects?

Tell the research team right away. You can get treatment for side effects. Learning about side effects is another reason doctors do clinical trials. You can also tell your regular doctor and health care team. If the side effects are too severe, you can choose to leave the clinical trial. If the clinical trial treatment causes severe side effects, the DSMB might stop the clinical trial.

What if the clinical trial staff switches me to a different group?

The clinical trial treatment sometimes clearly works better than the standard treatment. If this happens, the DSMB might want everyone in the clinical trial to have it. The clinical trial staff will talk with you before switching you to a different group. Ask the staff any questions you have about the clinical trial, including about your group and treatment.

Will I get a “sugar pill” or placebo?

Probably not. In cancer clinical trials, doctors usually compare the new treatment being studied to one or more of the standard treatments.

An inactive treatment is called a placebo in medical language. A placebo is a drug or treatment that looks like the real one, but is not. If there is a chance you might get a placebo, the informed consent form will say so. If you do get a placebo, you will also receive another treatment. You will never get only the placebo. Ask the research team any questions you have about this.

Learn more with free videos

PRE-ACT, Preparatory Education About Clinical Trials

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Related Resources

ASCO answers; Clinical TrialsDownload ASCO's free 1-page (front and back) fact sheet on Clinical Trials as a printable PDF. Order printed copies of this fact sheet from the ASCO University Bookstore.