Typically, taking part in a clinical trial does not cost anything for the participants. While clinical trials cost money to run, the sponsor of the clinical trial and the patient's insurance company will typically cover all the required care costs.

To make sure you understand the different costs and how to get the most coverage possible, it’s important for you know all the ways in which your insurance and other parties interact with clinical trials.

Knowing this can also help you decide between different clinical trials you're considering participating in.

The Affordable Care Act requirements

As of 2014, under the Patient Protection and Affordable Care Act, new health insurance plans must cover the routine cost of care for people participating in clinical trials that meet certain requirements (or are targeted for cancer). This means that an insurer cannot stop paying coverage because a person volunteers for a clinical trial, and they can't deny a person their right to participate in a trial by limiting their coverage for procedures that are associated with the trial.

The first thing to determine is if your insurance follows the obligations of the Affordable Care Act (ACA). Plans that are not grandfathered must follow the ACA requirements. "Grandfathered" health plans are ones that existed before the ACA went into effect, in March of 2010. However, if the plan has significantly reduced benefits or raised costs, the government may no longer consider it grandfathered.

To find out if your plan is grandfathered, contact your health insurance provider. The study team running a clinical trial may also be able to help you check how your insurance coverage works with clinical trials.

What qualifies as an approved clinical trial?

Trials that study methods to prevent, detect, or treat life-threatening illnesses are considered “approved” by the law. The clinical trial must be one of the following:

  • Federally funded. This means that at least one of the following organizations must approve or fund the trial: National Institutes of Health (NIH), including all organizations under it like the National Cancer Institute (NCI) and all organizations funded by it.

  • Conducted under an investigational new drug application reviewed by the FDA.

  • Have a specific exemption from the investigational new drug application.

A member of the study team (such as their clinical trial coordinator) can tell you if the study has approval for an investigational new drug, or likewise if it has a specific exemption.

Note: If you are participating in an observational study, where you’re simply continuing your usual treatment, you would continue paying for your care as you typically do.

What is guaranteed to be covered?

Your insurer must cover routine patient care costs. This means regular costs related to treating your conditions that you would normally get even if you didn't participate in a clinical trial. This includes, but is not limited to:

  • Doctor visits

  • Standard FDA approved treatments

  • Lab tests

  • Supportive therapies (such as those that help with side effects from the standard treatments)

  • Lab tests and other imaging tests

What are the costs not covered by insurance?

When you take part in a clinical trial, you may have extra doctor visits that you would not have when taking the standard treatment. During these visits, the medical team will carefully watch for side effects and monitor your safety. There also may be extra lab tests that are done purely to collect data about the new treatment. The research costs from these are not usually covered by health insurance, but are covered by the trial's sponsor.

Other research costs include:

  • The cost of the treatment or procedure the trial is studying (although keep in mind, this is often covered by the trial sponsor)

  • Any procedure only needed to collect data for the study

While these are almost always covered by the clinical trial's sponsor, the details of these costs should be discussed with the clinical trial team before enrolling.

Understanding Medicare and Medicaid

Unfortunately, the ACA does not affect the coverage of clinical trials provided through Medicare and Medicaid. Their regulations are a little different.


Medicare is the government health insurance for people age 65 and older. A Medicare plan will cover the following routine clinical trial costs:

  • The drugs, procedures, and services that it would normally cover if you weren’t enrolled in a trial

  • Medical care specific to the treatment that is being administered

  • Medical care related to any health complications from the trial -- this includes whatever is needed to manage side effects

Similar to the ACA, Medicare does not cover the treatment itself. Although, you may have broader coverage if you are also enrolled in a Medicare Advantage plan. For general questions about Medicare coverage, visit Medicare.gov or call 1-800-MEDICARE


Medicaid is a government funded health insurance program for low-income people and their families. There is no federal law that requires states to cover clinical trials through Medicaid. This means that each state’s program is different, and eligibility qualifications and coverage will vary.

For general questions about Medicaid, you can go to Medicaid.gov or call the Center for Medicare and Medicaid Services at 877-267-2323, or click here to learn more about your state's specific policy.

Planning and organizing other costs

In additon to the treatment and procedure costs from a trial, there are also other costs to consider, such as transportation and lodging costs. Here are some of the other financials to consider when planning to participate in a study.

Coordinating travel

You’ll likely have to make travel arrangements to get to your clinical trial appointments. Whether you plan on traveling by car, public transit, or riding with a family member there are often policies in place to help cover these costs.

The guidelines vary from study to study, and should be discussed with you during the informed consent process and outlined on the consent form. Often, travel costs will either be directly paid for by the sponsor, or there will be payments made based on the time spent traveling. Some trial sites simply offer a set stipend for all participants.

Overnight stays

Some clinical trials require an overnight stay. In these situations, you will likely be able to sleep at the trial site. If you must stay somewhere else, the costs may be covered by the trial sponsor. Make sure to discuss all your options with the study coordinator.

Compensation may come in the form of prepaid gas cards, taxi/ride share vouchers, or even airfare credits. Be sure to keep track of receipts, as some trials may require receipts to provide reimbursement, and medical-related travel is tax deductible.

There are also many independent organizations that exist to help manage medical costs. These include but are not limited to:

Angel Flight -- Volunteer pilots who fly patients to locations where they will receive life-changing medical attention

Patient Advocate Foundation -- Provides small grants to patients who need financial assistance.

CancerCare -- Provides small grants to people with many types of cancer

If you have any questions about managing the potential costs, feel free to reach out to our team!

Get the most from your coverage

As you, your doctor, or a member of the research team is checking with your health plan to find out which costs will be paid for, keep these key tips in mind to get the most coverage!

Request a case manager

Case managers are individuals from your insurance company who can help expedite any process -- from getting more coverage, to discussing appeals, to clarifying policies.

Understand your Explanation of Benefits (EOB) forms

EOB forms are sent to you by your insurance company. They list the cost of the treatments received and how much of the fee was paid for by the insurance company. It is possible that you will run into a plan that does not cover certain aspects of your trial that you (or your doctor) feel are necessary.

Whether it’s not covered within the ACA or your plan is grandfathered, you can argue your case.

  1. Ask if the doctor will write a letter explaining why a certain test or procedure is required. Have that sent to your case manager.

  2. If the company does not agree to cover it, in other words if your request is denied, you can then appeal the decision.

All denied insurance claims can be appealed. Here’s a list of numbers to call if you need help with the appeal: