Common Questions about Clinical Trials

Clinical trials are research studies in which real people participate as volunteers. Clinical research studies help us to improve our understanding of human health, growth, development and disease. Clinical trials might evaluate the effects of a biomedical or behavioral intervention on health outcomes.

Clinical trials have some level of risk. You’ll talk with your doctor about whether the potential risk is worth the potential benefit, given your health situation.

Researchers strive to make trials as safe as possible. A drug that is being tested for the first time in humans, for example, has gone through years of development and testing, often in donated human tissue, before being judged ready for testing in humans.

There are also strict safety protocols in place and continuous oversight.

There are numerous rules and regulations to protect patients.

First, participation in a clinical trial is always voluntary. If you decide not to participate, our medical teams will continue to provide the best care that is possible today. And if you do decide to participate, you can withdraw at any time.

Protecting clinical trial participants starts with writing the protocol. The protocol is a blueprint for the trial. It covers which types of patients will be included, the tests that will be done and on what schedule, any medications or other interventions that will be provided and on what schedule, and how long the study will last.

An Institutional Review Board (IRB) must approve and monitor the study. The IRB is a committee that includes both scientists and non-scientists, and is charged with ensuring that trials are both legal and ethical.

Federal regulators, including the National Institutes of Health and the U.S. Food and Drug Administration, also oversee trials.

Each clinical trial is asking a different question, so each trial is looking for different types of patients. Part of the plan for the trial is deciding how eligibility will be determined. Some aspects of eligibility could be:

• Age.
• Gender.
• Specific cancer diagnosis.
• Other medical conditions.
• Other treatments that have already been tried.
• Willingness to participate in extra clinic visits and monitoring.

For example, if a drug was designed to target a specific genetic mutation in lung cancer, then the trial would not be available for all lung cancer patients. Only lung cancer patients with that genetic mutation would be eligible.

As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of care. There are two types of costs in a clinical trial: patient care costs and research costs.

Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard treatment. These costs are often covered by health insurance. They include:

• Doctor visits.
• Hospital stays.
• Standard cancer treatments.
• Treatments to improve symptoms of cancer or side effects.
• Lab tests.
• X-rays and other imaging tests.

Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Examples include:

• The study drug, but this typically excludes the administration of the study drug.
• Lab tests performed purely for research purposes.
• Added X-rays and imaging tests performed solely for the trial.

The National Cancer Institute provides additional resources about costs and clinical trials.

If you have questions about what are considered patient care costs or research costs, contact your study coordinator.

When considering a clinical trial, you should also contact your insurance provider about the coverage of your patient care costs. To understand what you may need to pay out of pocket for your patient care costs during the trial, you should speak with your insurance provider.