What are the costs of clinical trials?

Most people who participate in a clinical trial do not have to pay more out-of-pocket for medical care than they would if they were not in a trial. The various medical and research costs are typically paid for by a combination of the trial sponsor, health insurance plans, and the patients themselves (e.g., to meet a deductible). However, every trial is different.

Before joining a clinical trial, you will receive an informed consent document that includes the details about the costs and responsibilities specific to the particular trial. You, or someone from the research team, will need to check with your health insurance provider to confirm coverage before you begin the study. Your research team can help answer your questions about costs. It may be helpful to ask them what the experience has been like for other patients in the study.

You can find out more about informed consent here.

Will I have to pay for any of the treatments or tests? What costs will my health insurance cover?

All trials are different, and it is important to understand the types of costs and who will be responsible for them in a specific trial before you agree to participate.

In general, there are a few types of costs. Some are usually covered by insurance and others may be paid for by the trial sponsor.

What are the types of costs in a clinical trial?

Routine care for melanoma would be needed regardless of whether someone is in a clinical trial or not. For example, visits to your doctor’s office or the hospital, standard approved treatments, managing symptoms, and routine laboratory testing and scans may be considered routine patient care costs. These costs are usually covered by health insurance, just as they would be for someone who is not in a clinical trial.

In fact, federal laws, mainly the Affordable Care Act, require that Medicare and most commercial health insurance plans cover routine care costs for people in clinical trials, as long as they are eligible for the trial and it is funded or approved by the federal government. However, there are some exceptions (for example, policies that existed before the Affordable Care Act became law in 2010) so insurance verification is an important part of the screening process before joining a clinical trial.

Regular healthcare plan limitations still apply for people who are participating in a clinical trial. For example, your insurance plan would not cover out-of-network provider visits as part of a clinical trial if your plan does not include out-of-network coverage.

Research costs are not usually a part of regular cancer care and are purely for research purposes. These can include the study drug being tested, laboratory tests for research purposes, or additional scans performed for purposes of the trial only. Health insurance plans do not usually cover these costs, but these expenses are often paid for by the trial sponsor.

Expenses for things like transportation, housing, loss of income due to missed work, and childcare are examples of additional non-medical costs that may need to be considered when deciding whether to participate in a clinical trial. Some of these expenses may also come up for routine treatment but may be more important for clinical trial participants who may need to make more frequent office visits.

These costs are different for everyone and will depend on your specific family and working situation as well as how close you live to the clinical trial center. Patients often need to cover non-medical costs themselves, so it is important for you to understand what will be expected of you during the clinical trial to get an idea of what costs you may expect (for example, traveling to a center outside your hometown for blood tests may take more time and cost more for travel versus having blood taken locally).

You can find out more about possible costs in the informed consent document and discuss any questions with your clinical research team, including whether the trial sponsor will cover any of the non-medical costs (e.g., transportation) related to the study.

Who pays if I’m injured in the trial?

All studies are different, and the informed consent document for a particular trial provides specific information about who will be responsible for costs related to complications or injuries as a result of the clinical trial. You can discuss any questions about this with the clinical research team. For example, the trial sponsor may have funds available to cover costs due to injuries during the trial that are not covered by insurance (e.g., copayments or deductibles).

Who can help answer any questions from my insurance company?

Before agreeing to take part in the study, you or someone from your doctor’s office or the research team will need to check with your insurance provider to confirm what costs your insurance plan will cover. Insurance verification is usually a standard part of the screening process that takes place after informed consent but before you begin treatment in a clinical trial. The clinical research team can help answer any questions about the costs of the study and who will be responsible.