Are Clinical Trials Free?

Participation in clinical trials requires thorough thought and consideration on the part of the patient. One of the questions potential participants may have is “are clinical trials free?” There is a common myth that volunteers have to pay for clinical trials, which could prevent people from enrolling even if they deem the clinical trial appropriate for their needs.[1]

The simple answer is that participants typically don’t have to pay from their own pocket to participate in clinical trials. However, there are various aspects involved in answering this question thoroughly; in this guide, we will explain how much clinical trials typically cost, who usually pays (funds) for them, and what that implies for you as a participant. The aim is to help you better understand clinical research and make an informed decision about participating in a clinical trial.

Clinical trial costs: Who pays for what?

The majority of clinical trials receive funding from two primary sources: government and the private sector.[2] In most cases, the sponsor will provide the treatment or drug being tested to the participants free of cost. The trial sponsor could be a government organization (like the National Institutes of Health, NIH), a pharmaceutical company, a medical research organization, or a drug developer. The study sponsor will also often cover any tests and medical visits required as part of the clinical trial. In some trials, participants may receive monetary compensation, for example for the costs incurred in traveling to and from the study site for study visits (more on this later).

However, it is important to understand that there is no general rule. Before participating in a clinical trial, you should clarify whether or not you may need to pay for anything, and if so, what is covered and what is not. The next step would be to check with your health insurance to understand whether or not those costs may be covered by your plan (it is also important to let them know you are planning to participate in a clinical trial in general, as insurers usually have specific regulations about this). Importantly, participating in a trial does not mean that the trial sponsor will pay for all of your medical expenses; most clinical trials will cover study-related costs but the volunteers (or their insurance) are still responsible for paying for any routine tests, medical visits, or treatments that fall outside of the study’s scope.

Participation in clinical trials: Do I need to pay to take part in a clinical study?

Before finalizing the clinical trial enrollment, every participant will receive an informed consent form (ICF). This document will outline everything that is involved in the study, including laying out the costs of the clinical trial that the study sponsor will cover and any expenses that you or your insurer may have to pay. The ICF should also clarify any monetary compensation you may be entitled to receive during the clinical trial. The ICF is the most reliable source for final information related to trial expenses and other details about the clinical trial.

Insurance coverage for clinical trial participants

As a volunteer, you can look to your health insurance provider if there are any costs related to your participation in a clinical trial. In 2014, the Affordable Care Act (ACA) added a clause to the Public Health and Welfare code of federal regulations, mandating health insurance providers to cover clinical trial-related costs faced by volunteers.[3]

According to this amendment, any health insurance company that covers qualified individuals must not deny or restrict:

• The participation of a volunteer in a clinical trial,
• The patient care costs associated with the clinical trial, provided the patient be i) qualified for the clinical trial and ii) participating in an approved clinical trial

This piece of legislation also prevents discrimination against an individual based on their participation in clinical trials. Insurance should cover phase I, II, III, and IV clinical trials aimed at the detection and prevention of life-threatening diseases, provided the clinical trial has federal funding and involves an FDA-reviewed interventional drug.

At the same time, the insurance company may not be required to cover:

• The intervention (drug or treatment) being administered in the clinical trial
• Costs that are not related to direct patient care
• Any service that deviates from the standard care of treatment for the disease or condition in question

Medicare

Part A and B of the original Medicare plan cover the costs of products and services related to an approved clinical trial.[4] These may include treatment of any side effects resulting from the research study and the cost of a hospital stay. The Medicare plan will not pay for anything being tested in the study that they wouldn’t cover normally. The original Medicare plan excludes any clinical research study expenses not directly related to the patient.

Paid clinical trials

Some clinical research studies may offer direct monetary compensation to their volunteers for participation; these trials are appropriately called ‘paid clinical trials.’ This practice is most common for earlier-phase trials, for which there is less evidence of the safety of the treatment. The exact financial compensation varies by phase and by specific trial. Generally, compensation is highest for phase I trials and tends to be lowest for phase IV clinical trials (correlating with the relative risk due to increasing amounts of safety data gathered throughout the subsequent phases).

Sponsors of paid clinical trials may also reimburse volunteers for any study-related costs. Such costs could include those related to travel, parking, meals, childcare, loss of income, and accommodation for overnight stays. Paid clinical trials strive to make participation more manageable and more enticing for volunteers.

An Institutional Review Board (IRB) thoroughly assesses the benefits of a research study against its potential risks – payment/compensation is not included as a benefit.[5] Rather, it’s more of an incentive to get people to participate without them having to worry about out-of-pocket expenses.

If you’re concerned about the costs of the clinical trial cost, here are a few questions to ask before enrolling:

• Is this a paid clinical trial? If yes, how much will I get paid?
• Is the compensation conditional on travel distance or any other factors?
• Will I be reimbursed for out-of-pocket expenses? If yes, which expenses exactly?
• What costs will the sponsor cover?
• Where will the clinical trial take place? I need to confirm whether that falls within my insurance provider’s coverage network.

How much do clinical trials cost for sponsors?

Now that we’ve discussed who typically pays for which aspects of clinical trials, compensation/reimbursement, and insurance coverage, let’s take a look at the overall costs of clinical research in general. The numbers may surprise you.

The median cost of a clinical trial was estimated to be $19 million.[6] The phase and length of the trial, the number of sites involved, staffing requirements, and many other study-specific factors significantly influence the final cost. Smaller studies with 100 participants were reported to cost an average of $6 million, whereas studies with over 1000 participants cost $77 million on average.[6] Clinical trial costs have also been increasing over the past decades, posing an increasing challenge to clinical trial sponsors.

Those costs may seem high, but consider this: Clinical trials are but one aspect of the overall clinical research process, which begins with drug development and ends with FDA marketing approval (although “post-marketing” Phase IV studies are often continued thereafter). New research shows that it costs between $161 million and $3 billion USD to bring a new drug into the market![6],[7]

Studies have indicated that the costs of clinical trials are higher in the US than in most other parts of the world, including Europe and Asia.[8] In the US, the per-patient cost of a clinical trial was estimated to be $41,413. The clinical trial sponsor may have to pay between $20,000 and $70,000 for medical tests and procedures for each patient enrolled in a clinical trial.[8] It could be helpful to have this perspective in mind when weighing the potential value and benefit of the study for you against any potential out-of-pocket expenses that you may be responsible for.

Potential hidden costs in clinical trial participation

Those who are asking the question “are clinical trials free?” may feel better knowing that their insurance provider is most likely on board with their participation in clinical trials. Despite that, as a participant, there are studies in which you may still have to pay out-of-pocket expenses. It is important to clarify with both the sponsor and your insurer, and to imagine what the study protocol requires of you in order to forecast ancillary (hidden) costs you may still run into even if you’re covered for most study-related expenses. Some of these costs might include travel expenses, meals and accommodation, childcare and support services.

Conclusions

There are many reasons to participate in a clinical trial, including contributing to the advancement of healthcare, accessing potentially breakthrough, novel drugs and treatments that aren’t yet available on the market, and learning more about your condition and becoming actively involved in your own healthcare management. Clinical trial costs are also a consideration and as a participant, it will be important to know which clinical trial costs will be covered by the study sponsor, your insurer, and those that you may be left to cover on your own.