Common Questions
The goal of clinical trials is to find out if a new test or treatment works and is as safe as possible. This must happen before a new medical intervention can be approved for use.
Clinical trials are studies that test new ways to prevent, detect, diagnose, or treat health conditions.
Volunteers who match study requirements – such as gender, age, condition, or treatment history – can join a clinical trial. A member of the study team will screen all volunteers to confirm they meet the requirements of the trial.
All trials have guidelines about who can be included.1 To find out if a trial is right for you, it’s a good idea to speak with your doctor. Here are some questions that might be helpful to ask:
• What is the purpose of the trial?
• Who is going to be in the trial?
• Why do researchers believe the study drug being tested may work? Has it been tested before?
• What kinds of tests and treatments are there?
• What treatments might I get?
• How do the possible risks, side effects, and benefits in the trial compare with my other treatment options?
• How might this trial affect my daily life?
• What will I have to do while I am in the trial?
• How long will the trial last?
• Who will pay for the study drug?
• Will I need to pay for anything to be in the trial?
• What type of long-term follow-up care is part of this trial?
• Can I get results of the trial?
• Who will be in charge of my care?
• What are my other treatment options?
• What is the purpose of the trial?
• Who is going to be in the trial?
• Why do researchers believe the study drug being tested may work? Has it been tested before?
• What kinds of tests and treatments are there?
• What treatments might I get?
• How do the possible risks, side effects, and benefits in the trial compare with my other treatment options?
• How might this trial affect my daily life?
• What will I have to do while I am in the trial?
• How long will the trial last?
• Who will pay for the study drug?
• Will I need to pay for anything to be in the trial?
• What type of long-term follow-up care is part of this trial?
• Can I get results of the trial?
• Who will be in charge of my care?
• What are my other treatment options?
You do not need to be referred by a doctor to join a trial. But some patients with diseases or health problems may learn about clinical trials from their doctor.
You should talk with the doctor who treats your disease about other choices you have.
There are possible benefits to taking part in clinical trials. The benefits of participating in a clinical trial may include:
• Regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals4
• Opportunity to help other people who need to be treated for the same or similar disease in the future1
• Chance to contribute to scientific understanding of a disease1
• Regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals4
• Opportunity to help other people who need to be treated for the same or similar disease in the future1
• Chance to contribute to scientific understanding of a disease1
All clinical trials have risks. Your study team can talk to you in more detail about the risks of being in the trial. The potential risks of participating in any clinical trial may include:
• The new treatment being studied may not be better than or as good as standard therapy1
• The new treatment being studied may have harmful side effects that doctors do not expect or that are worse than those associated with standard therapy1
• Health insurance may not cover all routine care costs in a trial1
• You may have extra visits to the study doctor and more tests done.
• Even if the new treatment works, it may not work for all patients.
• The new treatment being studied may not be better than or as good as standard therapy1
• The new treatment being studied may have harmful side effects that doctors do not expect or that are worse than those associated with standard therapy1
• Health insurance may not cover all routine care costs in a trial1
• You may have extra visits to the study doctor and more tests done.
• Even if the new treatment works, it may not work for all patients.
Your study doctor can talk with you about how long the study will take. Some studies take only a few months, while others can take years. It depends on the reason for the study and how it is designed.
Clinical trials can be done at hospitals, medical schools, or doctors’ offices. Some trials have more than 1 study location.
Not all trials pay participants, but some do pay for travel, time, and commitment. The amount varies. The study doctor can tell you more about this before you decide whether to take part or not.
If you are thinking about participating in a clinical trial, it’s a good idea to contact your health plan to confirm what costs they will cover. Federal law requires that most insurance companies cover routine care costs if 5:
• You are eligible for the clinical trial
• The trial tests how to prevent, detect, or treat cancer and is approved by the federal government
• The trial does not include out-of-network doctors or hospitals
However, health insurers are not required to cover research costs. This may include the costs of extra doctor visits, tests, or procedures that are required for the trial. In many cases, the organization sponsoring the trial will cover these research costs.5
• You are eligible for the clinical trial
• The trial tests how to prevent, detect, or treat cancer and is approved by the federal government
• The trial does not include out-of-network doctors or hospitals
However, health insurers are not required to cover research costs. This may include the costs of extra doctor visits, tests, or procedures that are required for the trial. In many cases, the organization sponsoring the trial will cover these research costs.5
The costs of care for people participating in a clinical trial fall into three general categories1:
• Routine care costs (sometimes called standard care costs)
• Research costs
• Additional personal expenses, such as travel costs
Routine care costs are costs associated with treating a person's disease whether or not they are in a trial. These costs are usually covered by health insurance, but requirements vary by state and type of health plan.1 If you are thinking about participating in a clinical trial, it’s a good idea to contact your health plan to confirm what costs they will cover.
Research costs are costs associated with conducting a clinical trial. These costs may include the costs of extra doctor visits, tests, or procedures that are required for the trial but would not be part of routine care. Research costs are usually covered by the organization that sponsors the trial.1
• Routine care costs (sometimes called standard care costs)
• Research costs
• Additional personal expenses, such as travel costs
Routine care costs are costs associated with treating a person's disease whether or not they are in a trial. These costs are usually covered by health insurance, but requirements vary by state and type of health plan.1 If you are thinking about participating in a clinical trial, it’s a good idea to contact your health plan to confirm what costs they will cover.
Research costs are costs associated with conducting a clinical trial. These costs may include the costs of extra doctor visits, tests, or procedures that are required for the trial but would not be part of routine care. Research costs are usually covered by the organization that sponsors the trial.1
Some federal programs help pay the costs of care in clinical trials:
• Medicare may reimburse some of the costs of participating in a clinical trial. More information is available online or by calling 1-800-633-4227 (1-800-MEDICARE)6
• Beneficiaries of TRICARE, the Department of Defense's health program, can be reimbursed for the medical costs of participating in certain clinical trials. To learn more, visit TRICARE Cancer Clinical Trials6
• The Department of Veterans Affairs (VA) allows eligible veterans to participate in nationwide prevention, diagnosis, and treatment studies sponsored by the National Cancer Institute. You can learn more by visiting the VA’s website6
• Medicare may reimburse some of the costs of participating in a clinical trial. More information is available online or by calling 1-800-633-4227 (1-800-MEDICARE)6
• Beneficiaries of TRICARE, the Department of Defense's health program, can be reimbursed for the medical costs of participating in certain clinical trials. To learn more, visit TRICARE Cancer Clinical Trials6
• The Department of Veterans Affairs (VA) allows eligible veterans to participate in nationwide prevention, diagnosis, and treatment studies sponsored by the National Cancer Institute. You can learn more by visiting the VA’s website6