Trial sites and sponsors should work together to implement strategies that minimize financial and time burden on the participant and/or their caregivers. Work with patients and caregivers when you’re planning the trial to determine potential solutions with respect to expense reimbursement. CTO has resources to help you engage patients and caregivers.
Clear communication from sponsors to sites and sites to participants on what expenses are eligible for reimbursement will improve the participant’s ability to make decisions about participation.
For some participants, reimbursement of incurred expenses as soon as possible may be essential for continued participation in a trial.
Minimize upfront cash outlay by the participant whenever possible. For example, consider parking tokens or chits, pre-arranged, and paid for transportation, prepaid accommodations, prepaid expense cards. For some participants, this may be critical for their participation.
Reimbursement for expenses incurred and for trial participation should be clearly identified as a reimbursement, not income in order to avoid an impact on the participant’s income.
There may be differences in access to technology for participants. For example, even online activation of prepaid cards may be a hurdle for some participants.
Minimize the reimbursement paperwork and process whenever possible. For example, petty cash options at the research site can reduce the receipt burden. Determine if original receipts are needed or scans/pictures are acceptable and if a reimbursement form needs to be filled out by the participant or if someone from the study team can help.
For some study populations, a caregiver may be required at study visits. Consider reimbursement for caregiver expenses where appropriate (e.g. Vulnerable populations, pediatrics, etc.). An example of this may be childcare costs while attending the study visit with the participant.
There are other types of financial burdens not quantified or compensated. For example, time for travel, time for involvement, arrangements for childcare, etc. Consider decreasing unnecessary in-person visits or allowing visits to happen at local satellite clinics.
Organizing travel and logistics may be a lot of work for some participants. Utilizing a ‘participant concierge’ resource may ease the burden on participants both financially and logistically when booking travel.
Note: This resource list is not exhaustive and listing a resource does not denote its endorsement or promotion.
