Cost Related Questions About Clinical Trials

Abstract ideas about equality, progress and human rights are interesting topics that frequently come up when talking about healthcare and more specifically – clinical trials. We have already shared quite a bit of our own perspective on them while discussing our mission and values.

The ins and outs of a clinical trial are also a subject of discussion here on the blog and we like to go into detail about what a clinical trial is, how it is conducted and what patients need to know before applying.

There are, however, more practical topics we haven’t touched on yet. You all seem to have, for example, quite a lot of questions and concerns about costs. What the clinical trial sponsor covers and what your insurance company covers; who pays for what and can you even afford to participate in a trial. It’s a bit confusing, we know.

FindMeCure believes in affordable healthcare, because we believe health is a human right. That’s the reason why we completely understand and relate to your financial concerns and we’ll try to answer your questions as in depth as we can.

However, keep in mind that healthcare policies vary from country to country and what costs your insurance covers depends on where you live and the recent policies adopted in the health sector. To make things more inconsistent, different clinical trial sponsors cover different costs, so no matter what is generally true, you still have to check what applies to that particular trial you have in mind.

Will I get paid? No. If you’re looking to participate in a treatment-oriented clinical trial in phase II, III or IV, you’re not going to get paid to do so. Only healthy volunteers in the first phase of a clinical trial get paid as a way to encourage people to help in the process of assessing the safety of an IND (investigational new drug). That being said, those volunteers in phase I are not guinea pigs – the drug, device or procedure has already been tested on animals (or synthetic tissue) before it ever reaches trials with humans, so it’s far from a shot in the dark.

Will I have to pay to enroll in a clinical trial? No. Clinical trials need participants and they already have a very strict set of enrollment criteria, so putting an additional barrier between medical research and people who need the advancements in development is just silly and counterproductive.

Researchers and the pharmaceutical companies that usually sponsor clinical research are interested in getting FDA approval and getting the new drug out there as soon as safely possible. Making participants pay for enrollment significantly slows down the process of testing and, in turn – the moment of truth when researchers find out whether an IND is a success or a failure. This delay results in additional costs for the sponsor.

Will I have to pay for the drug, device or procedure in testing? No. The rule of thumb is that the clinical trial sponsor covers the cost of the treatment provided by the clinical trial. It’s actually why it costs so much to conduct a clinical trial – the treatment itself is often quite expensive. Hence, why it can take researchers some time to find a sponsor and get their research founded.

Will I have to pay for the additional tests and procedures needed for research purposes? No. Any test or procedure aiming at determining the effects of the treatment in development is paid by the sponsor of the clinical trial and it’s not covered by most insurance companies, unless your healthcare plan specifically states otherwise – but that’s a bit of a stretch. Generally, however, covering such costs is the responsibility of the sponsor, as it’s purely needed for research.

Will I have to pay the routine cost of care? It depends. As of 2014 in the US The Affordable Care Act also known as Obamacare states that insurance plans should cover the costs of medicines, hospital stays, doctor visits, tests or anything else a patient would typically require for treating a life-threatening disease, regardless of their participation in a clinical trial.

There are, of course, laws about routine costs of care that vary from state to state. Under Trump, however, healthcare policies are not yet determined and this might change.

If you live in or are insured outside the US, check what your particular healthcare plan covers. The easiest way to do this is to contact your personal physician – they should be well informed and prepared to discuss your options.

What are the costs I should be prepared to cover? This isn’t always the case as some clinical trials encourage people to participate by covering these costs as well, but generally travel costs are the patient’s responsibility. Other costs that you might need to prepare for in advance are childcare costs, loss of income due to time away from work and accommodation if the research facility is in another town or city.

Consult a clinical research coordinator prior to applying – they will be able to help you determine the financial resources you’ll need over the full course of the trial and they should also be helpful if you need some coordination between the trial and your insurance company.