Imagine a patient participating in a clinical trial for a new vaccine. They take a half day of PTO to visit the clinic, which is a short 15-minute drive from their home. After an hour visit, they are given $50 as compensation – a reasonable amount which they spend on a nice dinner. This describes a typical experience for a certain kind of patient.
What happens when some of those details change? Instead of taking PTO, the patient misses a shift at work and subsequently loses income to visit the clinic. They may have to ride the bus for an hour to get there. This patient is given the same $50 as before, but for them, that doesn’t even come close to replacing the lost income.
For a voluntary activity like a clinical trial, $50 per visit doesn’t begin to cover the burdens that some patients face in order to participate.
Nothing stirs up anxiety in the clinical trial industry like the topic of patient compensation, but this apprehension adds to the burden of participating patients. There are legitimate concerns around undue influence through compensation, but it’s not difficult to avoid. There are robust safeguards in place for compensation, with Institutional Review Boards (IRBs) providing guidance and the FDA outlining permissive guardrails.
Patients, as healthcare consumers, make a choice about the care they receive, meaning compensation is already part of that decision. Good, thoughtful compensation respects the patient and offsets the burden of participation, while not pushing participation. The clinical trial industry misses the opportunity to respect the patient due to this fear of undue influence.
The Patient Perspective
IRBs are required to review protocols following criteria outlined by the FDA, which include obtaining informed consent from the patient. The regulatory criteria read (in part):
What is the regulatory framework for talking to patients about the value of a clinical study? IRBs are well versed in the value of compensation for patients, and we’ve collaborated with Advarra, a provider of IRB and Institutional Biosafety Committee (IBC) solutions to advance clinical trial research, to paint a clearer picture of these challenges and opportunities for clinical study participants.
The Regulatory Framework of Participation
IRBs are required to review protocols following criteria outlined by the FDA, which include obtaining informed consent from the patient. The regulatory criteria read (in part):
James also notes that regulations don’t say to eliminate undue influence, just to minimize the possibility. IRBs carefully consider the protocol, procedures, study population (including locations), and payment plans when determining if the amount of money offered to participants represents an undue influence. In Advarra’s experience, we rarely need to significantly modify a participant compensation plan, which might imply either sponsors are good at setting an appropriate amount, or that the sponsors could offer participants’ more without reaching the level of ‘undue influence.
Balancing Out the Burden
With IRBs rarely disapproving payment plans proposed by the sponsor or site, and with patients highly motivated by compensation when participating, we have an opportunity to offer more value to patients.
When a patient weighs the value of a study against the burden of participation, that value needs to offset the burden or risk the patient walking away. Consider some patient burdens:
Patient Time
Office visits, at-home journal entry, transportation, and any activity required by the study.
Out-of-Pocket Expenses
The cost of gas, public transportation, lost wages from missing work, parking, childcare and more.
Physical Demands
Invasive procedures and side effects of treatment.
Medical Tradeoffs
The potential for a placebo and washing out of existing medications.
By looking at patient compensation through this lens of value and burden, the industry acknowledges the strain placed on the patient instead of framing compensation as a misunderstood attempt at bribery.
Compensation will need to be adjusted by study. For example, SubjectWell saw an increase of over 400% in randomization rates when a meningitis study offered compensation, but compensation barely affected recruitment for a cosmetic enhancement trial because patients found value in the treatment itself. Many diabetes trials also see no impact on recruitment from compensation for a variety of reasons. In general, compensation improves randomization rates across the board, increasing participation and offsetting patient burdens.
The burdens of clinical study participation also disproportionately impact patients of color, young patients, and low-income patients. These burdens help result in patient populations that are older (30%) and skew white (75%), compared to the national population (17% and 60%, respectively) – patients who can typically afford to miss work and cover more expenses.
The FDA recognized the lack of diversity in clinical studies, and recently published new guidance to encourage more diverse patients to participate in a trial
Moving Toward a Patient-Centered Solution
Our industry already has a full set of tools and options to increase the value of a study for patients, thanks to clear guidelines from the FDA and recommendations from IRBs, like the guidance from Advarra above.
Sponsors should become a leading voice in this discussion. With IRB regulations broadly supporting patient compensation, sponsors don’t need to fear undue influence. Sponsors can design compensation for their studies and confidently message the plan to patients. By leveraging this incentive, studies will recruit more interested and more diverse patients. Compensation is a leading motivator across demographics, and even more valuable to diverse patients. With sponsor-designed plans, sites will have clearly defined benefits to aid patient recruiting and retention.
IRBs are incredibly helpful in this process, but they can’t design a study’s compensation scheme for a sponsor. It’s their job to let the sponsor know when compensation is off course…but as Advarra noted, it’s currently rare for IRBs to deny study designs due to compensation, leaving room to explore the boundaries of more reasonable compensation.
SubjectWell Team
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