Access to a specialty treatment through a paid clinical trial often comes paired with some hurdles of its own.
Many clinical trials come with financial aid of some form to support participation, but the amount offered and the form it is offered in can vary from trial to trial.
The one major rule that the FDA enforces is that payments should never be presented in a way that could coerce a patient to do something that he or she would not otherwise do.
The payment structure varies between different clinical trials, and usually falls into one of the four compensation models: The Market Model, The Wage Model, The Reimbursement Model, and The Appreciation Model.
At minimum, sponsors will typically cover costs related to travel and inconvenience that patients incur while participating in a trial.
Keep in mind that the FDA states that payment should be made periodically throughout the study. In other words, being paid or reimbursed for participating should not depend entirely on completing the whole study.
You should always feel safe and never feel forced to follow through with a study if it isn't in your best interest.
Paid Clinical Trials: Finding A Trial Near You
Most often, people take part in clinical trials after hearing about them from their doctors. However, there are many other ways of finding a paid clinical trial that provides you with the right monetary (and non-monetary) compensation.
To find a paid clinical trial that is right for you, you can follow these general steps of finding and applying to any clinical trial. Please note that almost all platforms which list available clinical trials will not specify the payment amount that is given to participants, as it varies from location to location.
After you’ve found a study that you qualify for and would like to participate in, the easiest way to get information on compensation amounts is to get in touch with the study team. If you need help reaching the study team, services like Clara Health can help you get started!
While most clinical trials offer the treatment for free, the compensation amount and extra reimbursement can depend on the condition the trial is targeting, as well as the phase the treatment is in. For example, phase 1 clinical trials tend to compensate participants much better, and so do studies that are looking for healthy participants or patients with chronic conditions.
Paid Clinical Trials: How Payments Are Offered
There are four main compensation models that structure how and when you will be paid for participating in a clinical trial. It is important to ask questions and understand if the compensation model that the researcher is using for your trial is ideal for you.
- Market Model
In this model, compensation is derived from the supply and demand and other local conditions. Based on other available offers, the researchers determine what, when, and the amount offered, while taking into account the level of difficulty in finding study participants.
Usually, the more difficult it is to find qualified participants, the larger the compensation amount will be. It is common to see a variation in the payments amount between different study locations in multi-site studies, as the local market conditions can differ.
For example, if a site is located in an area that will require a long commute for the majority of its participants, the sponsor may offer a higher payout, to compensate for increased travel costs and inconvenience.
- Reimbursement Model
The participant provides receipts for reimbursable activity -- primarily gas, parking, lodging, and meals. The sponsor will reimburse expenses that are incurred during the trial, and in some cases this can even include reimbursement for lost wages. If the latter is part of the compensation structure, this can mean that participants may be reimbursed at completely different rates from one another.
This model is primarily meant to incentivize and support patients living farther away from the trial site. Participants keep track of their pre-approved study related costs, and later submit receipts in order to claim their reimbursements.
- Wage-payment Model
Participants can earn a standardized hourly “wage” offered as compensation for their participation, or by reaching certain study milestones. This amount is based on the time and effort required of the participant.
In this model, study participation is treated as a job that doesn’t require any skilled labor, and the compensation amount is typically in line with the local minimum wage. Reasonable additions may also be made for additional risks and inconvenience.
- Appreciation Model
This tends to come in the form of a token of appreciation at the end of the study. Unlike the other three models, it has little impact on study recruitment and is more likely to require study completion. This can be small gifts, such as gift cards or thank you letters.
Depending on which model is picked by clinical trial sponsors, it will affect the time necessary for clinical trial sponsors to recruit the required number of participants. The better the incentive, the more willing people will be to participate.
You will be required to spend your time, as well as become exposed to potential risks and side effects, depending on the study that you choose. It is important that you evaluate the pros and cons of the compensation structure that is being offered, especially if earning money is your primary goal for your participation.
Paid Clinical Trials: Taxes & Compensation
While compensation can be minimal, in the form of reimbursements for expenses related to time and travel to participate in the study, there are many studies that offer additional payouts to incentivize participants to enroll or stay. If you have enrolled in a paid clinical trial, you may have to revisit your payment records come tax season.
The IRS requires that payments over $600 for clinical trial participation must be reported on tax returns. If cumulative payments within a calendar year reach or exceed the $600 amount, the study coordinators will require a W-9 tax form from each participant. In addition, a Form 1099-MISC will also be generated by the site once that amount is reached, and a copy will be sent to both the IRS and the participant.
Paid Clinical Trials: Reimbursements & Exceptions
Reimbursements (or any other payments based on receipts which cover expenses incurred by the participant) are excluded from this requirement. These include receipts you submitted to the study staff for pre-approved travel, lodging, and meals up to the maximum allowed limit.
President Barack Obama’s “Ensuring Access to Clinical Trials Act of 2015” allows patients with rare diseases to receive up to $2,000 per year without having the payment count as income. In the US, a rare disease is considered as a condition that affects less than 200,000 people in the country.
This differs from the $600 payment limit which is targeted at healthy individuals taking part in paid clinical research trials. It also won't jeopardize eligibility for SSI and Medicaid.
Out of the estimated 7000+ rare diseases in the US, only a few hundred have FDA-approved treatments. It is especially challenging to recruit patients for rare disease clinical trials, and this law is meant to incentivize their participation, which is critical to finding new treatments or cures.
What Clara Does
Clara Health was established to help patients match with relevant clinical trials & research studies. We believe that all patients should have the power to access the most advanced healthcare available and our goal is to make this process as seamless as possible.
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- If you’d like a helping hand, we can walk you through the process of finding and applying for clinical trials.