- Clinical Trials: What You Need to Know
- Why do we need clinical trials?
- What happens before clinical trials?
- Some facts about clinical trials: Important points to keep in mind
- What are the phases of clinical trials?
- Phase 0 clinical trials: Exploring if and how a new drug may work
- Phase I clinical trials: Is the treatment safe?
- Phase II clinical trials: Does the treatment work?
- Phase III clinical trials: Is it better than what’s already available?
- Submission for FDA approval: New drug application (NDA)
- Phase IV clinical trials: What else do we need to know?
- Who sponsors and runs clinical trials?
- Should I think about taking part in a clinical trial?
- Answers to some common questions about clinical trials
- Other questions you should ask your research team
- What protects the study participants?
- What’s out there? Finding clinical trials
- How do I figure out which study is for me?
- What about cost? Will my insurance cover it?
- What would it be like to take part in a clinical trial?
- What if I’m not eligible for a clinical trial?
- Summing it all up
What about cost? Will my insurance cover it?
It’s important to get these questions answered before deciding to take part in a clinical trial. Recent studies have shown that the overall costs of taking part in a clinical trial are not much more than the costs of treatment outside of a study. Still, insurance coverage can vary widely.
When insurers cover costs related to clinical trials, it’s usually only for tests, treatments, or doctor’s visits that would have been part of your treatment plan if you were not taking part in a study. In other words, they are not likely to pay for special tests or treatments you are getting just because you’re in the study.
The study sponsor (whether it’s the government or a pharmaceutical or biotechnology company) usually provides the new treatment at no cost and pays for special testing or extra doctor visits. Some sponsors may pay for more than this; for example, some may offer to pay you back for travel time and mileage. It’s important to find out what will be paid for before entering the study.
In the past, insurers were sometimes reluctant to pay for any of the costs related to a clinical trial. Their concern was that they would be paying for treatments that had not been proven to work.
In recent years, many (but not all) major insurance providers have volunteered to cover some of the costs of clinical trials. Still, they may limit which types of trials they will cover. They’re more likely to pay for costs from phase II or phase III clinical trials, but most of the time they look at each request on a case-by-case basis.
Medicare normally covers any cancer care when it’s part of either:
- A clinical trial for the diagnosis and treatment of cancer; or
- A clinical trial funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups, or another federal agency that funds cancer research
This care may include the following:
- Routine tests, procedures, and doctor visits
- Services or items that are part of the experimental treatment, such as costs to give the investigational drugs
- Health care needs linked to being in a clinical trial, such as a test or hospitalization because of a side effect or problem
Costs that are not covered:
- Investigational drugs, items, or services that are being tested as part of the clinical trial
- Items or services used only to collect data for the clinical trial
- Anything that is provided for free by the sponsor of the clinical trial
- Any co-insurance and deductibles
Cancer prevention trials currently are not covered by Medicare. If you are not sure whether your trial meets all of the requirements, discuss these concerns with your doctor or call the Medicare information number (1-800-633-4227). Other trials may be covered, so be sure to ask about other clinical trials before you begin taking part in one that may not be covered.
Laws about insurance coverage of clinical trials
Recognizing the importance of clinical trials, many states have passed laws about insurance coverage for research studies. And more states are now looking at such laws. A few states have worked out voluntary agreements with insurance companies to cover clinical trials.
The types of studies and exact coverage required by these laws vary from state to state—some cover all clinical trials, while others may cover only certain phases of clinical trials. For a state-by-state list of clinical trials insurance laws, see our document Clinical Trials: State Laws Regarding Insurance Coverage.
The federal government has become involved, too. One of the goals of the 2010 Affordable Care Act is to make coverage available for cancer treatment that’s done in clinical trials. As of 2014, insurers will not be allowed to drop or limit coverage because a person takes part in a clinical trial for cancer or any other life-threatening disease. This should allow more people to take part in them.
What you can do
If possible, find out what your insurer will cover before you get involved in a clinical trial.
Find out if your state has laws that require them to cover routine costs of clinical trials. Then gather as much information as you can about the study and contact your insurance provider to find out about coverage. Many providers may not be able to give you a simple yes or no answer, because they may review claims on a case-by-case basis. But you may be able to find out if they’ve covered costs for clinical trials like yours (or ones that studied the same treatment) in the past.
Have a summary of your study available, and, if possible, results of any previous studies of the treatment. You may need to ask your doctor or the study’s research coordinator to help you get this information. If needed, your doctor may be able to give your insurer the reasons this study is a good match for you.
Study sponsors are often eager to recruit eligible patients for their clinical trials, and they may be willing to cover some costs your insurance does not. If needed, ask your doctor or the research coordinator to contact the study sponsor on your behalf.
Last Medical Review: 09/21/2012
Last Revised: 09/21/2012