Clinical Trials
What Is a Clinical Trial?
A clinical trial is a type of medical research study. After being developed and tested in a laboratory, potential new ways of fighting cancer need to be studied in people. If found to be safe and effective in a clinical trial, a drug, device, or treatment approach may be approved by the U.S. Food and Drug Administration (FDA).
Everyone with cancer should carefully consider all of the treatment options available for their cancer type, including standard treatments and clinical trials. Talk to your doctor about whether a clinical trial may make sense for you.
Phases
Most cancer clinical trials focus on treatment. Treatment trials are done in phases.
- Phase I trials study the dose, safety, and side effects of an investigational drug or treatment approach. They also look for early signs that the drug or approach is helpful.
- Phase II trials study how well the drug or approach works against a specific type of cancer.
- Phase III trials test the drug or approach against a standard treatment. If the results are good, it may be approved by the FDA.
- Phase IV trials study the long-term safety and benefit of an FDA-approved treatment.
Who Can Enroll?
Every clinical trial has rules for joining, called eligibility criteria. The rules may be about age, cancer type and stage, treatment history, or general health. These requirements ensure that participants are alike in specific ways and that the trial is as safe as possible for the participants.
Informed Consent
Clinical trials are managed by a group of experts called a research team. The research team will review the study with you in detail, including its purpose and the risks and benefits of joining. All of this information is also provided in an informed consent form. Read the form carefully and ask questions before signing it. Take time to discuss it with family, friends, or others you trust. Keep in mind that you can leave and seek treatment outside of the clinical trial at any time.
Start the Conversation
Don’t wait for your doctor to bring up clinical trials. Start the conversation and learn about all of your treatment options. If you find a study that you may be eligible for, ask your treatment team if you meet the requirements. If you have already started standard treatment you may not be eligible for certain clinical trials. Try not to be discouraged if you cannot join. New clinical trials are always becoming available.
Frequently Asked Questions
There are many myths and misconceptions surrounding clinical trials. The possible benefits and risks are not well understood by many with cancer.
Will I get a placebo?
Placebos (inactive versions of real medicines) are almost never used alone in cancer clinical trials. It is common to receive either a placebo with a standard treatment or a new drug with a standard treatment. You will be informed, verbally and in writing, if a placebo is part of a clinical trial before you enroll.
Are clinical trials free?
There is no fee to enroll in a clinical trial. The study sponsor pays for research-related costs, including the study drug. You may, however, have costs indirectly related to the trial, such as the cost of transportation or child care due to extra appointments. During the trial, you will continue to receive standard cancer care. This care is billed to—and often covered by—insurance. You are responsible for copays and any costs for this care that are not covered by your insurance.Finding a Clinical Trial
In the United States:
Worldwide:
Need help finding a clinical trial? NCI's Cancer Information Service (CIS) can help.
1.800.4.CANCER (1.800.422.6237)
cancer.gov/contact
This information can be found within the NCCN Guidelines for Patients, available for free download at NCCN.org/patientguidelines.