I’ve been on three sides of the health care equation: I’ve beaten stage 4 colorectal cancer, I’m the mother of a son with an ultra-rare genetic abnormality, and I now work as the chief patient officer for Parexel, one of the world’s largest clinical research organizations. Having seen what people go through as they navigate the health care system and try to participate in clinical trials, I know that the road to participation must be smoother and easier — and not a drain on their bank accounts.
Fully engaged and supported participants form the foundation for successful clinical research. Yet for many people, the financial considerations associated with trial participation — loss of earnings due to time off work, travel expenses, child care costs, and other expenditures — pose significant barriers. These financial obstacles often deter people from enrolling in or continuing with clinical trials, ultimately delaying the progress of medical advancements.
According to the Equitable Access to Clinical Trials (EACT) project, people cite cost as one of the top reasons for deciding not to participate in clinical trials. Despite the clear need for financial support, trial sponsors do not consistently deploy reimbursement and compensation programs. Even when compensation is offered, it may fail to adequately cover the full spectrum of costs that participants incur.
To change this paradigm, clinical trial sponsors must understand the challenges and regulatory considerations for patient financial programs — both real and perceived — and recognize their significant influence on health equity and participation in clinical trials.
The price of participation
Social drivers of health, the wide set of forces and systems shaping all aspects of a person’s life, affect one’s ability to participate in a clinical trial. While steps have been taken in recent years to resolve health inequities driven by these systemic issues, the financial burdens underlying many of these concerns have yet to be addressed in a universal or consistent way.
Participants and their care partners can encounter various expenses to take part in a clinical trial. While some of these costs are covered by insurance and trial sponsors, others must be paid out-of-pocket. These can include insurance copays and deductibles, travel, lodging, and meals. And some costs that can have a significant financial impact, such as child care and elder care or lost wages incurred when taking time off work, are not routinely accounted for.
Members of Parexel’s Patient Advisory Council were asked recently whether trial sponsors had covered their costs. Only two of eight respondents reported they had. As one participant noted, “It’s very stressful. I have to take time off from work. I have good insurance, but I still pay a lot of money every year. I do it because the trial is keeping me alive.” In contrast, a participant who had their costs covered said, “I didn’t have to lift a finger or pay a dime. It was so easy.” This divergent feedback highlights the urgent need for a more equitable approach.
Reimbursement, stipends, and compensation: understanding the differences and implications
To enhance recruitment and retention, and promote greater health equity, the greatest opportunity for clinical research would come from standardizing fair and comprehensive reimbursement policies.
In recent years, both institutional review boards and regulatory bodies have become more permissive of reimbursement and stipends. U.S. government agencies have made it clear they don’t consider reasonable reimbursements for trial participation to be inducement or coercion, meaning there is nothing trial sponsors should be fearful of when offering compensation.
But a gap currently exists between patient expectations and what is practically possible. During a recent meeting of Parexel’s Patient Advisory Council, members recommended offering participants a flat rate stipend of $200 per day in the U.S., in addition to covering expenses. But if there were more than three trial visits per year, that could result in a tax liability for the participant and potential loss of eligibility for government benefits. For example, the income limit to receive Social Security disability insurance is $2,590 a month. If a trial participant is receiving disability checks, a stipend could count against that and jeopardize their coverage. So even when there is clarity, programs may still fall short of covering the full spectrum of costs incurred by participants and meeting their expectations.
It would help for sponsors to partner with regulators and government tax departments to establish and evolve standards to achieve financial neutrality for participants in clinical trials. Such a collaboration would enable payment programs to become better recognized as a patient-centric issue, opening the door for more robust payment offers and plans. With this, there would be fewer reasons for clinical research organizations not to participate in compensation programs.
To simplify such programs, organizations could enlist third-party vendors to standardize their operations, ideally based on patient feedback, to conduct administrative tasks and proactively elicit patient feedback during trial planning to ensure that the potential costs are fully understood. This can help relieve financial burdens, and has also been shown to improve participation within marginalized and underserved communities that often experience their own unique set of barriers to care.
Comprehensive compensation matters
Making participation in clinical trials financially neutral is a matter of accessibility and fairness across clinical research. There are far too many potential participants, particularly those who are economically vulnerable — whether due to limited financial resources or other social drivers of health — who are kept from taking part in clinical research simply due to the cost. Some can’t afford to take time off from work. Others can’t afford the incidental expenses brought on by transportation or meals. The additional care often necessary for their loved ones while they dedicate their time to science is also beyond the reach of many. If sponsors cannot ensure their equitable participation, clinical trials will always remain a step behind in their efforts to effectively match the study population to the patient population.
The research community has only just begun to tackle the issue of health inequity. This work offers an opportunity to examine current standards and work with regulators and governments to do more to support trial participants’ financial burdens and shift perceptions that coverage of trial-related costs should be equated as earnings. Patients’ voices should not just be heard; they should be a guiding force in the quest for better health outcomes for all.
As I look back on what the clinical trials community has achieved, and look forward to the challenges and opportunities ahead, I’m reminded of the fact that the journey of a thousand miles begins with a single step. Everyone working in clinical trials must embrace this opportunity to reevaluate and standardize reimbursement policies. Breaking down barriers and accelerating the pace of clinical research will ensure that all everyone, regardless of their financial circumstances, will have the opportunity to be part of the journey to better health for all.
Stacy Hurt is the chief patient officer at Parexel.