Increasing Clinical Trial Diversity Through Patient-First Payment Options
Patient-first trial design, based around the tenets of adaptability and personalization, has emerged as a key solution to increase diversity and improve trial outcomes for all.
Non-Hispanic white populations comprise 78% of participants enrolled in US clinical trials, despite only accounting for 61% of the country’s population.1 Increasing clinical trial diversity is imperative for health equity and ensuring the clinical research sector develops treatments suitable for all Americans, no matter their background.
Sam Whitaker and Jason Dong are co-founders and co-CEOs of Mural Health.
Patient-first trial design, based around the tenets of adaptability and personalization, has emerged as a key solution to increase diversity and improve trial outcomes for all. There is an increasing focus on the need to flex trial designs to meet the needs of participants, whether they are logistical, financial, or educational.
However, uptake of new technologies that offer patient optionality is far from universal, in part due to the industry’s desire to stay in its comfort zone. This hesitation is particularly apparent in clinical trial payments.
Financial and logistical barriers persist for clinical trial participants
In recent years, there has been greater recognition from FDA regulators of the nuances and different ethical considerations of reimbursement for expenses, compensation for time and burden, and incentives. Despite this, the industry has been slow to adopt a similarly nuanced approach to the use of patient-focused payment technologies, and it shows:
The routine costs associated with participation in a clinical trial—such as travel, accommodation, and childcare—continue to create barriers to enrollment for economically disadvantaged populations.
Patients with a household income below $50,000 are less likely to participate in clinical trials and trial participation decreases as income decreases.2 This includes American Indian, Alaskan Native, and Black ethnic groups in the United States, who all had a median household income below $50,000 as of 2021.
Why traditional payment solutions aren’t working
There are several existing methods for reimbursing clinical trial participants, but most pose problems for both sites and trial participants.
Reimbursement via bank transfer or check. In these cases, reimbursements are issued for submitted expenses, or an average amount of estimated expenses is provided. But these methods are often admin intensive, creating more burden for sites and slowing down the overall process. An online qualitative study of rare disease patients and their caregivers found most felt payments were too slow, with respondents reporting waiting weeks or months to be reimbursed.3 These delays are likely to have a greater impact on individuals of lower socio-economic status.4
Prepaid debit cards. Many sponsors have opted to use prepaid debit cards, which removes the need for participants to wait for reimbursement claims to be processed. However, cardholders face a series of fees, including having to pay for activation, transactions, ATM withdrawals, and periods of inactivity—a high burden for socio-economic groups already struggling to participate in clinical trials.
The value of modern, patient-first reimbursement options
Patients are used to speed, convenience, and accessibility in their daily financial life. Payment app PayPal has more than 420 million users worldwide5 and 60% of consumers say they are interested in using a digital bank in the next year.6 Participants, and by extension sponsors, would benefit from similarly flexible solutions in clinical trial payments.
To ensure a truly patient-first approach, next-generation payment systems should:
- Give every participant the same high level of security, control, and oversight, as well as the option to choose how they get paid, whether that is via PayPal, bank transfer, or checks that can be cashed at minimal cost.
- Be easy to use. Participants should be given appropriate training to ensure there is no added burden.
- Be available without the fees, extraneous charges, and delays of the old systems.
- Include tools such as in-app ride hailing functions, which invoice the sponsor directly and eliminate the participant’s worry of not being able to afford to get to appointments or paying out of pocket and waiting months for reimbursement.
It’s time for a new approach
Financial burden is one of the core barriers to participating in a clinical trial. This hinders diversity, which in turn, impacts the efficacy of treatments for the entire American population. New patient-first approaches can give participants of all backgrounds the financial control and flexibility they need to sign up and stay on track.
To truly embrace patient optionality, sponsors should focus on proven barriers to participation, eradicate erroneous fees and give every participant the option to take control of their trial experience.
About the Authors
Sam Whitaker and Jason Dong, co-founders and co-CEOs, Mural Health.
References
1. 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%20and%20Guarneri%2C%202009). Last accessed: 14 February 2023.
2. National Library of Medicine (2016) UngePatient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4824189/ Last accessed: 6 April 2023.
3. Clincierge. (2022) Clinical Trial Payments: Patient Insights in Rare Disease Trials. Available at: https://www.clincierge.com/clinical-trial-payments-patient-insights-in-rare-disease-trials/ Last accessed: 6 April 2023.
4. Journal of Clinical and Translational Science (2021). Fair payment and just benefits to enhance diversity in clinical research. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8427546 Last accessed 17 August 2023.
5. Global Data (2022). Number of Active PayPal Accounts: Global (Q3 2015 – Q1 2022). Available at: https://www.globaldata.com/data-insights/financial-services/number-of-active-paypal-accounts-global/ Last accessed 17 August 2023.
6. Bankrate (2023). Digital banking trends in 2023. Available at: https://www.bankrate.com/banking/digital-banking-trends-and-statistics/ Last accessed 17 August 2023.
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