With the clinical research sector striving to ensure the products it develops are suited to all the people who rely on them, no matter what their background, patient centricity has emerged to improve the diversity of clinical trial participants.
The core principle is building a study infrastructure that can overcome barriers to inclusion, whether they be logistical, financial, or educational, by flexing to meet the needs of individual participants. But while the technology that puts study participants in charge of their own research experience exists, uptake is far from universal.
At least part of the problem is the industry’s tendency to stay within its comfort zone rather than embrace new solutions. And nowhere is this more apparent than in the realm of participant payments.
A Focus on Payments
Financial challenges such as paying for childcare or travel are often cited as a barrier to participation and a reason for dropouts, meaning the improvement of payment systems has garnered much attention in recent years. However, many commonly-used solutions are inflexible for participants and some may increase disparity by making those who can least afford it pay fees.
Many sponsors have, for example, turned to pre-paid cards. While this option enables those who do not have a bank account to sign up, there is limited data on sponsor and participant preference – just because something is better than a bank check does not mean it is the best option. The data also suggests being “unbanked” is not the main financial barrier to clinical trial research participation.
A 2021 FDIC national survey found that just 4.5% of US households were “unbanked”, the lowest figure ever recorded, and pointed to a continuing downward curve in the statistic.1 Figures from Statista show that in the UK, 4% of the population is unbanked, a figure that stands at just 2% in Japan, 1% in Germany and Belgium, and 0% in Canada, Denmark, the Netherlands, Finland, Sweden, and Norway.2
It is clear, then, that a lack of banking services is not the problem here. Rather, the sticking point is that traditional clinical trial payment schemes tend to be lacking in speed, convenience, and accessibility. Prepayment cards compound, rather than mitigate, these existing challenges.
To start with, cardholders will usually face a barrage of fees, which may include activation fees, transaction fees, ATM withdrawal fees, or inactivity fees. In addition, the supporting infrastructure tends to be inaccessible to participants, and this can leave them waiting, with no updates, for much-needed payments. Moreover, the method is often admin-intensive, piling the burden of paperwork completion onto already overburdened sites, and slowing the process overall.
Instead, most clinical trial participants, and by extension sponsors, would benefit from flexible solutions that allow them to choose how to receive payment – and do not charge them for the privilege.
Accounting for Unbanked Clusters
The sector’s quest for greater diversity is based on the knowledge that trials predominantly enroll white men, with women, the elderly, and people of color being consistently underrepresented. Non-Hispanic white populations, for example, comprise 78% of participants enrolled in US clinical trials, despite only accounting for 61% of the country’s population.3
When looking to improve diversity, we must acknowledge unbanked individuals may be concentrated in populations that do not usually take part in clinical trials.
The FDIC survey found that in black communities, for instance, 13% of people are classed as “unbanked” compared to just 3% of the Caucasian population. There is also a difference along geographical lines, with almost 13% of people in Mississippi being classed as “unbanked”, compared to less than 1% in New Hampshire, Vermont, and Utah.3
It could be argued then, that sites predominantly serving populations that are more likely to be unbanked, such as hospitals operating in black communities in Mississippi, may be good candidates for a prepaid card.
However, this does nothing to negate the disadvantages of the model. Rather, it only serves to increase disparity by enforcing unfair, unjustified charges on those with the least wherewithal to service them.
Choice and Respect
Rather than focus on pre-paid cards that charge fees, provide a limited choice of payment methods, and block participants from raising their own payment requests, sponsors and contract research organizations could benefit from taking a completely fresh view.
Next-generation payment systems offer every participant the same high level of security, control, and oversight. They allow them to choose how they get paid, whether that is by PayPal, bank transfer, or for the “unbanked”, checks that can be cashed at minimal additional cost.
By allowing participants to raise their own payment requests and easily track incoming funds, these platforms empower people to take part in research while never adding the ATM fees, monthly inactivity fees, or other extraneous charges that other systems often do.
In-app ride-hailing functions, which invoice the sponsor directly, mean trial participants never have to worry about having enough money to get to appointments or wait months for reimbursements to materialize.
In essence, advanced payment solutions focus on what matters most to all clinical trial participants – speed and ease of payment – and give them the financial control and flexibility they need to sign up and stay on track.
Inclusive Technology
Financial challenges are often cited as a barrier to clinical trial participation. Whether reimbursing expenses or compensating participants for their time, sponsors need to do everything they can to mitigate the economic impact of taking part.
Prepayment cards may be a well-established approach, but their lack of flexibility and their additional costs mean they are far from patient-centric. Furthermore, data shows being “unbanked” is unlikely to be the biggest financial barrier to clinical trial participation.
Rather than defaulting to what they are used to, sponsors would do better to focus on the areas that prove to be consistent barriers to participation by eradicating erroneous fees and putting every single participant in charge of their own trial experience.
References
- FDIC. (2022). 2021 FDIC National Survey of Unbanked and Underbanked Households. Available at: https://www.fdic.gov/analysis/household-survey/index.html Last accessed: 14 February 2023.
- Statista. (2023). Share of the population without access to the services of banks or similar organizations worldwide in 2021, by country. Available at: https://www.statista.com/ statistics/1246963/unbanked-population-in-selected-countries/ Last accessed: 14 February 2023.
- National Academies of Sciences, Engineering, and Medicine. (2022). Improving representation in clinical trials and research: building research equity for women and underrepresented groups. Available at: National Academies of Sciences, Engineering, and Medicine. (2022). Improving representation in clinical trials and research: building research equity for women and underrepresented groups. Available at: https://www.ncbi.nlm.nih. gov/books/NBK584396/#:~:text=An%20FDA%20summary%20report%20of,Ortman%20 and%20Guarneri%2C%202009). Last accessed: 14 February 2023.
Author Details
Sam Whitaker, Co-Founder & CEO; Jason Dong, Co-Founder & Chief Business Officer - Mural Health.
Publication Detail
This article appeared in Pharmaceutical Outsourcing:Vol. 25, No. 1Jan/Feb/Mar 2024Pages: 26-27
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