Clinical Trials

Why Should I Consider a Clinical Trial?

Many people are unsure of the purpose of a clinical trial. In response, NCCN developed resources to provide people facing cancer, their caregivers, and their families with information on clinical trials and how to talk to their doctors about whether a clinical trial may make sense for them. Information on clinical trials is referenced in the library of NCCN Guidelines for Patients^®. 

Download a free handout on why you should consider a clinical trial. 

Translations

What Is a Clinical Trial?

A clinical trial is a type of medical research study. After being developed and tested in a lab, potential new ways of treating 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 and are done in phases.

• Phase 1 trials study the safety and side effects of an investigational drug or treatment approach.
• Phase 2 trials study how well the drug or approach works against a specific type of cancer.
• Phase 3 trials test the drug or approach against a standard treatment. If the results are good, it may be approved by the FDA.
• Phase 4 trials study the safety and benefit of an FDA-approved treatment.

Who Can Enroll?

It depends on the clinical trial’s rules, called eligibility criteria. The rules may be about age, cancer type and stage, treatment history, or general health. They 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 research team. This group of experts 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 people 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.

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. But you may need to pay for other services, like transportation or childcare, due to extra appointments. During the trial, you will continue to receive standard cancer care. This care is often covered by insurance.

Questions to Ask Your Care Team

There is no fee to enroll in a clinical trial. The study sponsor pays for research-related costs, including the study drug. But you may need to pay for other services, like transportation or childcare, due to extra appointments. During the trial, you will continue to receive standard cancer care. This care is often covered by insurance.

1. Do you recommend that I consider a clinical trial?
2. How do I find clinical trials that I can participate in?
3. What is being tested in the clinical trial?
4. What are the risks and benefits of the clinical trial?
5. How long will I be in the clinical trial?

This information can be found within the NCCN Guidelines for Patients, available for free download at NCCN.org/patientguidelines.