There is no single “standard” payment model for compensating research subjects for their participation in a clinical trial. While some studies don’t offer any type of payment or compensation to patients, others offer a specific sum per visit and/or reimbursable amount for a research volunteer’s out-of-pocket expenses. Today, the topic of ‘if and how’ to pay patients for their participation is still up for debate.
Research subject payments: patient stipends
Patient stipends are defined as a fixed sum provided to human research subjects after a particular activity, such as a site visit, has been completed. Stipends are commonly used in clinical trials and are often expected by study volunteers. In some cases, stipends are used by sites as a way to increase enrollment. However, for the purposes of this post, we’ll focus on how stipends are used by sites to help defray the intangible and sometimes tangible costs for study participation.
Research participation can inconvenience a patient in multiple ways. Stipends can help ease the non-monetary, intangible burdens and inconveniences that patients may face, from time spent away from family and friends or on logistics, such as finding childcare or transportation for visits. Fixed stipend payments can also be used to help offset expenses that a patient may accrue, which could preclude persons with significant financial burdens from participating in a study.
Stipends and reimbursements: what’s the difference?
Unlike stipends, reimbursements are typically payments that refund a participant for approved out-of-pocket expenses. In order to avoid unduly burdening a patient for participating, reimbursements are meant to bring patients back to a cost-neutral state.
Reimbursements typically require documentation in the form of receipts. Common reimbursable items can range from mileage, transportation, parking, lodging, meals and more. For some trials, stipends and/or reimbursable amounts are combined into one lump sum, regardless of a patient’s individual circumstances and financial situation.
Full reimbursement for approved out-of-pocket expenses can help subjects who wish to participate, but don’t have the luxury of being able to pay expenses without being completely reimbursed for those costs. For those with financial burdens, not being fully and quickly reimbursed for out-of-pocket expenses can take these study volunteers into further debt.
Stipends vs. reimbursements: Which is best?
When choosing if and how to compensate or reimburse patients for their participation, sponsors and sites should consider whether their chosen model is not only the best method for their business, but is also a fair and equitable way to pay subjects for their time and actual accrued expenses directly related to the trial. Payments to participants should be carefully considered depending on differing circumstances, so certain participants don’t receive the proverbial “short end of the stick.”
To illustrate this point, we’ll compare Patient A to Patient B:
- Patient A: Is paid minimum wage, has young children and uses public transportation. Patient A has both tangible and intangible costs, including planning visit logistics, spending time away from family and friends and out-of-pocket expenses. Depending on how far the trial location is and what form of transportation is needed to get to the site, Patient A’s expenses may not be fully reimbursed in an inclusive lump sum payment model. To this end, this patient may not be placed back into a cost-neutral state; they may actually incur debt to participate in the study.
- Patient B: Has a car, lives only a short distance from the research site with no children and no loss of pay for participation. In Patient B’s case, the tangible and intangible expenses aren’t comparable to Patient A’s situation. For Patient B, a lump sum payment could actually provide an additional source of revenue for the participant.
So, when considering patient-centricity and fairness to research subjects with differing circumstances, does a one-size-fits all lump sum payment model with combined stipends and reimbursements make sense, regardless of a participant’s situation?
Why lump sum payments aren’t the answer
When considering how to pay participants, it should always be best practice to do what’s right for the patient and not what’s easiest for the site or sponsor. For sites that still pay patients via cut checks, the costs, time and room for error in check processing can be a persuasive reason to pay a single lump sum versus separate stipend payments and reimbursable costs, regardless of a patient’s circumstances and actual out-of-pocket expenses.
However, with an automated research subject payment systems available, time intensive, error-prone and expensive manual check processing can be easily overcome. New technology can allow each protocol’s stipend amounts per visit to be pre-set in the system, while also allowing out-of-pocket expenses by reimbursement type (from mileage to parking) to be pre-set, including maximum allowable amounts. For reimbursable expenses, some situations may require a patient to incur costs over the approved allowable amount. In these situations, a study coordinator can explain the patient’s specific scenario to finance via comments in the system, allowing finance to make a final determination of reimbursable amount dependent on each patient’s particular circumstance.
Today, sponsors, CROs and sites have come to understand how being patient-centric can have a positive impact on enrollment and retention during a trial. One easy way to get there is by being aware of patients’ individual situations while working to address them through a more patient-focused and equitable approach of paying stipends separately from reimbursements. This approach allows sponsors and sites to not only impact their participants’ satisfaction and overall success of a trial by paying patients not only for the intangible costs of participation, providing full reimbursements, but saves your organization time and effort in the payment process.
Want to learn more about how Indiana University used a patient-centric way to pay stipends and reimbursements to participants while lowering administrative burden? Read this case study.