Many people wonder whether a clinical trial will cost them money. The answer depends on the study and on your health insurance. Many of the costs are covered by the study’s sponsor or by your health plan, if you have one. Sometimes you pay some costs yourself. This guide describes how costs often work in the United States.

The sponsor is the person or organization in charge of the study, such as a drug company, a medical center or a doctor.

Research costs: often paid by the study

Some costs exist only because of the study. These are called research costs. They include:

  • the study medicine or treatment
  • lab tests done only for the research
  • extra X-rays and other scans done only for the study
  • extra doctor visits that you would not have with your usual care

Health insurance often does not pay for research costs, but the study’s sponsor may. Many studies pay for the treatment being tested and for research-related tests and visits.

Routine care: often billed to insurance

Other costs are for care you would get even if you were not in a trial. These are called routine care costs, or patient care costs. They can include doctor visits, hospital stays, standard treatments, treatment for symptoms or side effects, lab tests, and X-rays and other scans.

These costs are often covered by health insurance. You, or your insurance, still pay for your regular health care while you are in a study.

Travel and other costs

Taking part may mean traveling to the study site. That can bring other costs, such as travel, lodging, meals, parking, or care for children or older relatives while you are away.

Some studies help with these costs. Some may pay for research-related travel and lodging, or for costs such as parking or meals. Ask the study team whether the study offers financial help, or knows of support organizations that do.

Some studies also pay people for taking part. The amount is different from study to study.

The consent form describes a study’s payments and costs. In the United States, FDA rules say that if a study the FDA oversees might cost you extra, the consent process must explain those costs.

Health insurance in the United States

Check with your health plan before you join. Insurance might not pay for care you get because you are in a study, even when it is the same standard care you would get anyway.

In the United States, a federal law, the Affordable Care Act, can help. It says group and individual health plans cannot deny or limit coverage of routine patient care costs for certain people in certain clinical trials. Ask your plan whether this applies to you and your trial.

The National Cancer Institute suggests calling your plan, for example at the customer service number on the back of your insurance card, and asking:

  • Does the plan cover routine patient care costs for people taking part in clinical trials?
  • Does the plan need to review the trial before it decides to pay? This is called pre-authorization. If so, what information does the plan need?

Ask whether someone at the hospital or clinic can help you work with your health plan, such as a financial counselor or a research coordinator.

If your plan denies a claim, contact the plan’s billing office for help. Your insurance policy explains the steps for an appeal.

Medicaid is a health insurance program for people who cannot afford regular medical care. Each state has its own rules about who can get it. In the United States, Medicaid must cover routine patient care costs for people with Medicaid in qualifying clinical trials. Ask the study team whether your trial qualifies.

Medicare

Medicare is a federal health insurance program for people aged 65 or older and people with certain disabilities. In the United States, Medicare covers some costs, like office visits and tests, in certain clinical research studies.

You may pay 20% of the Medicare-approved amount, depending on the treatment you get. The Medicare-approved amount is the payment amount that Medicare sets for a covered service or item. The Part B deductible may also apply. Part B is the part of Medicare that covers certain doctors’ services, outpatient care, medical supplies and preventive services. A deductible is the amount you must pay for health care before Medicare or your other insurance begins to pay.

Ask your doctor or other health care provider how much a test or service will cost.

Questions to ask before you agree

Before you join, ask the study team which costs the study covers and which it does not. These questions can help:

  • Which of my costs will the study pay for, and which will be billed to me or my insurance?
  • If my insurance is billed, how much will I have to pay myself, for example a deductible or a copay?
  • Does the study help pay for travel, parking, lodging or meals?
  • Will I be paid for taking part? If so, how much?
  • If I am hurt because of the study, who pays for my care?
  • Is there someone who can help me with insurance questions?

Your care team can help you weigh the costs of a study along with everything else that matters to you.