Patient Safety in Clinical Trials

Clinical trial participants are a vital part of cancer research and there are federal rules in place to help ensure the safety and ethics of clinical trials. Watch to learn more about how your safety is protected on clinical trials.

https://cancer.gov/patientsafety
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For more on clinical trials, visit: https://www.cancer.gov/clinicaltrials
To find NCI-supported clinical trials, go to: https://trials.cancer.gov
Need help finding a trial? Have a cancer-related question? Call, e-mail, or write the NCI Contact Center at: https://www.cancer.gov/contact
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Patient safety in clinical trials. The most important member of any clinical trial team is you, the patient. So important, that efforts to protect your safety begin even before the trial itself does. A clinical trial in the U.S. may only enroll patients after its protocol is approved by a group called an institutional review board, or IRB. IRB members include scientists as well as nurses, advocates and others. Their job is to monitor the clinical trials and protect participant safety. The protocol describes the study's goals and methods and outlines how the participant safety will be ensured. IRB members review the protocol to make sure that the risk of harms is as low as possible and that any potential harms are a reasonable part of the research study. Another important safety step is the informed consent process. Before you can join a trial, the
research team will fully discuss the trial with you. If you decide to join, you will sign an informed consent form to confirm that you understand what's involved. You are encouraged to ask questions at any point before or after joining the study, and of course you may always choose to leave the study. It's completely up to you. Once a study begins, its scientific progress and the safety of its participants are regularly monitored. The study may be changed or even stopped to ensure the patient's safety. Clinical trial participants are a vital part of cancer research, better cancer care tomorrow depends on what we learn from clinical trials today. For more on how your safety is protected on clinical trials visit the National Cancer Institute's website at cancer.gov/patientsafety and thank you.