Financial reimbursement for clinical trial participation costs: a pilot feasibility study.

Abstract

Background: Clinical trial participants rarely represent the real-world treatment population, potentially due to costs associated with participation. Monetary reimbursement for trial-related costs could address financial barriers to trial recruitment and retention.

Methods: This mixed methods, pilot, feasibility study provided financial reimbursement to women with breast cancer participating in a clinical trial. Patients were reimbursed $1,000/month during their first four months of trial participation, surveyed biweekly to assess changes in financial toxicity, then interviewed to explore the effects of receiving reimbursement on trial-related costs and recruitment and retention. Mixed-effect modeling and thematic analysis were completed. Feasibility was defined as 80% retention of patients on the reimbursement study, with those retained completing 75% of surveys.

Results: Of 39 consented patients, 33 patients completed the pilot study (85% retention, 100% survey completion). Patients were a median 52 years old (IQR 44 to 59), 48% Black, 67% privately insured, and 42% found it difficult to live on their current income. Patient financial toxicity modestly decreased. Patients (n = 32) reported using the reimbursement to pay for trial visit-related food, transportation, caregiver expenses, and out-of-pocket medical costs. Patients felt receiving reimbursement affected trial retention more so than recruitment, stating "I would have enrolled regardless…[but knowing] it wasn't going to place a financial strain on us because of these reimbursements…It made it easier for me to feel good about continuing."

Conclusion: Reimbursement for clinical trial-related costs is feasible, suggests decreases in financial toxicity, and is a promising approach to improve trial retention outcomes in women with breast cancer.

Clinicaltrials.gov id: NCT05871125.