Financial toxicity in early-phase cancer clinical trials: A review of sponsor-supplied information at a large trials unit.

1526 Background: Financial toxicity (FT), the objective financial burden and resulting subjective distress experienced by oncology patients, adversely impacts clinical outcomes and access to care. Reimbursement practices between studies vary, possibly exacerbating the lack of representation of people from socioeconomically deprived areas and marginalized groups in early phase cancer clinical trials (EPCCTs). An ASCO roundtable in 2018 emphasized the need for clear details on out-of-pocket costs for trials. Studies in EPCCTs show FT is a recognized problem; however, management of this remains inconsistent. Methods: A retrospective portfolio review of open EPCCTs at a large UK cancer centre (Jan-Dec 2025) was conducted to assess reimbursement practices. Sources included informed consent forms (ICFs), contract trial agreements (CTAs) and sponsor provided patient materials. Reimbursement details (including amounts and timelines) were also assessed. Results: 64 studies were reviewed, encompassing 41 sponsors (38 industry and 3 academic). Reimbursement was mentioned in ICFs for 62 studies (96.8%) and by 39 sponsors (95.1%). The 2 studies lacking information were academic studies. Specific reimbursable activities were described in 15 studies (23.4%) across 11 sponsors (26.8%). No sponsor included a defined reimbursement timeline in any provided materials. Only 1 sponsor (2.4%) provided additional reimbursement information for patients. Third party vendors for reimbursement were used for 18.8% of studies, with 8 different vendors across 10 sponsors. Reimbursement processes were often detailed in CTAs, with 55 studies (85.9%) outlining specific reimbursable activities. Of 8 academic studies reviewed, 75% listed a maximum budget for each patient to cover the whole study duration (median £350; range £300-£500). Among studies reporting mileage repayment (53; 82.8%), the median rate was £0.45/mile (range £0-£0.45). Median patient travel expense entitlement per visit, where mentioned (55; 85.9%), was £150 (range £40–£700), while refreshment reimbursement was noted in 26 studies (40.6%) with a median value of £15/visit (range £5–£80). The total reimbursement offered per patient per visit was reported in 55 studies (85.9%), with a median of £152.50 (range £40–£1,145). Additional costs covered included reimbursement for carers (9 studies; 14.1%) and unforeseen/inconvenience payments (2 studies; 3.1%). Conclusions: Reimbursement terms are regularly specified in CTAs but there is limited inclusion in patient-facing trial documents and lack of flexibility for additional costs. Academic studies restrict reimbursement. Patients may decline clinical studies due to fear of financial toxicity, compounding health inequity. We are partnering with patients to co-develop clearer communication about reimbursement, supporting informed decision-making prior to study enrollment.