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Worried About Clinical Trial Costs? Here’s What You Need to Know

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clinical trial costs

Although people may opt not to participate in clinical trials for various reasons, health experts estimate that financial concerns play a large part in their decision-making process. When talking to potential participants, experts have found that they were worried that they wouldn’t be able to afford a clinical trial, consistent care, and other indirect costs that may be associated with being in a trial. However, surveys also show that a lot of people don’t have much information about clinical trials. As a result, they may not know that joining a clinical trial might be more financially feasible than they think. If you want to join one of these excellent studies, but are worried about the costs, then you’re in the right place. 

How to Find Out What You’ll Pay For

Being invited to take part in a clinical trial is just the beginning. Before you’re officially enrolled, the clinical trial coordinator has to ensure that you’re aware of all the aspects of the study. While you’ll likely have a lot of questions, it’s important to know what you’ll be responsible for financially. 

Some of the questions you should ask include:

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  • What costs will the clinical trial sponsor cover?
  • Will all my visits be at this site? If not, where else will I need to go?
  • If I have to travel, will I be reimbursed for it–including meals, and indirect costs such as childcare?
  • If there is reimbursement, how will this be handled?
  • Will any of the costs associated with this clinical trial be covered by insurance?
  • Do you have anyone on your team who works specifically with insurance companies?
  • Has anyone had trouble getting approval from their insurance company to cover the costs of similar trials?
  • Are you able to help me with an appeal if my claim is denied?

Of course, these are only a few suggested questions, but they should get you on the right path. You can always ask follow-up questions based on the coordinator’s answers. Most importantly, if you’re not ready to be enrolled in the trial because you’d like some more information from your health insurance provider, ask the coordinator how long you have before you need to make a decision. 

RELATED: Clinical Trials: Are They Safe?

What Patients Generally Pay For

While the details of a study can vary, you generally don’t need to pay out of pocket just to participate. In most clinical trials, the sponsor will handle the costs related to the research, such as the drug being used in the study, imaging tests, blood tests, and extra doctor’s visits. Depending on the study, though, you may have to cover a few of these expenses. That’s why you need to ask the coordinator to outline what’s covered and what’s not, as your insurance provider might not cover them either. 

When it comes to the costs you need to take care of, it’s typical for patients in a clinical trial to pay for the things they manage outside of a clinical trial. This can include regular doctor visits, hospital stays, the standard treatment as prescribed by your doctor, treatments that manage the side effects of your usual treatment, and regular lab tests. Sometimes, these costs may be covered by your insurance, and the clinical trial sponsor may cover copays as well as deductibles. Again, that’s information you may be able to get from the coordinator. 

If you’re participating in a clinical trial, you also have to consider the indirect costs you may incur. You may need to travel to the study site or to other locations where the required tests are performed. While traveling, you may need to pay for meals and hotel stays, depending on how far you are from home. Additionally, you may need to pay for childcare or care of a dependent if you’re a caregiver. 

It will be good to have an idea of what these costs might be and how you’ll pay for them before you commit to joining a clinical trial. That’s because you need to avoid interruptions in your care as much as possible.

clinical trial costs

RELATED: 5 Reasons to Enroll Yourself in Clinical Trials

How to Navigate Your Health Insurance

Ideally, you should reach out to your insurance provider about what they may cover during a clinical trial before agreeing to participate. If someone associated with the clinical trial works with insurance companies, then that’s a good place to start. They can guide you in who to talk to and what you need to find out. 

If you’re on your own, though, use the customer service number on the back of your card. When talking to your insurance company, a few of the questions you should ask include:

  • Does my plan cover routine patient care costs if I participate in a clinical trial?
  • If it does, do I need to get pre-authorization?
  • What information do I need to submit for pre-authorization?
  • If pre-authorization isn’t required, can I get a letter stating that for the organizers of the clinical trial?

Though your insurance company will provide a list of required documents for pre-authorization, you should know that you may need copies of your medical records, a letter from your doctor, and a copy of the informed consent for the trial. 

When talking to your insurance company, it’s important to give them the deadline that you would have received from the clinical trial coordinator. This will ensure that you get the documents or pre-authorization done in time to start treatment. 

Unfortunately, some people will have their claims denied. That doesn’t mean it’s the end of the road for you. You can file an appeal with your insurance company because claims may be denied for various reasons. Some companies deny claims because of incorrect billing or diagnostic codes, questioning whether or not the treatment is necessary, or the experimental nature of the treatment. 

If you get denied, you should submit your appeal letter as soon as possible so they have time to process it before your deadline. To increase your chances of a reversal, it’s critical to include all the applicable information they need to consider. Typically, this starts with your name, policy number, claim number, and the type of treatment you’re being denied. 

You should then go on to state why you’re appealing the decision while including a brief description of your medical history and connecting the clinical trial to an improvement in your condition. If any sections in your health plan support coverage of the treatment provided by the clinical trial, you should include that as well. 

Of course, health experts will strengthen your appeal letter. That’s why you should have any scientific evidence, test results, medical records, and literature that support the treatment. This may likely be available from the clinical trial coordinator, but you can do some research. You should also ask your doctor for statements that support the treatment and how it can improve your health. These can be especially helpful if your claim was denied because of the experimental nature of a treatment. 

Finally, you should ask for an expedited review so you can hopefully get a reversal in time for the clinical trial. When asking for this kind of review, you should let the company know that not getting a timely reply can be harmful to your health, as you may miss the trial’s deadline. 

Clinical trials can make a positive impact on the health of many people. However, it can be hard to apply for one when you’re worried about the costs that may be incurred. Instead of avoiding these studies altogether, talk to your insurance company and the clinical trial coordinator. You may find that it’s not as expensive as you think, and you can get the care you need. 

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