Breaking barriers: Upfront expense payments to ease the economic burden for clinical trial patients.
Year: 2025
Type: conference-abstract
Abstract: e23160 Background: Participation in clinical trials (CT) often imposes significant challenges on patients, beyond emotional and time commitments. The economic burden associated with being out-of-pocket (OOP) is a major barrier, particularly for individuals from lower socio-economic backgrounds, limiting their participation and retention in CT. Currently, Patients are required to cover their expenses upfront themselves, retain receipts, and submit claims for reimbursement. This process can take weeks, causing financial strain on patients, making CT less accessible to certain patient groups. To address this issue, we have developed an efficient and streamlined upfront payment management process to minimise the economic and administrative burden for both patients and CT sites. Methods: A collaboration between the Drug Development Unit at the Royal Marsden (RM) and the Institute of Cancer Research, Public and Patient Group at the RM, Barts NHS Trust, Vall d' Hebron Institute of Oncology, Clinica Universidad de Navarra, Roche/Genentech and third-party vendor, Greenphire, tackled key challenges such as Logistics of payment processes, Tax implications, Fiscal impact on trial sponsor, Country specific aspects and Regulatory and Ethics approval for the process, piloting in one of the Roche/Genentech sponsored trial AND finding solutions for these challenges. Results: A comprehensive upfront payment process (Table 1) was designed to support patients from pre-consent through to trial completion. Key features are: Tax-exempt paymentsReasonable OOP expenses are exempt from Tax implications. Individualized expense assessmentPayments are calculated per CT visit based on national guidelines and documented for audits. Seamless patient paymentsA portal within Greenphire facilitated real time direct payments via debit card or bank transfer where allowable. Regulatory integrationUK regulatory approval was secured. Approval in Spain is on-going. Conclusions: The upfront payment process effectively minimizes OOP expenses, reduces site burden, and improves the patient experience. Addressing other barriers, eg childcare, carer and pet-care, will further enhance CT accessibility, ultimately fostering a more equitable environment. Expanding this process across more CT will improve inclusivity and diversity and will provide measurable outcomes. · Pre-consent Patients OOP expenses are assessed prior to consent visit. · Informed Consent Patient’s consent is obtained before sharing personal details with Greenphire · Payment Set-up Greenphire is informed of patient’s details · First Visit On first consent visit, patients receive OOP expense covering two visits, one for the current visit and one for the next visit, via the Greenphire portal.· Subsequent visits From the second visit onwards, patients received a sum covering their next visit in advance, ensuring patients are never out-of-pocket.
Source: Journal of Clinical Oncology
Authors: Chiara Martinelli, Lyra del Rosario, Jennifer Ball, Ruth Davies, Angelina McLeod, Jose Manuel Ordonez, Cristina Ramon, Johann S. De Bono, Markella Boudioni, Jennifer Lauman, Adam Sharp, Mary Van Zyl, Ana Matres Rojo, Cristina Perez, Laura Arribillaga, Gabriel Canel, Maria Luisa Bezares, Maria Lapuente, Eric Mackelprang, Bindumalini Rao Baikady
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4410811722