When it Comes to Clinical Trial Travel, Soothing Recruitment and Retention Headaches Goes a Long Way

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When it Comes to Clinical Trial Travel, Soothing Recruitment and Retention Headaches Goes a Long Way

Part 1 of 3

By Franc Jeffrey

As many as 30% of subjects taking part in Phase III clinical trial participation drop out. Gruelling schedules, high travel costs and the time taken to be reimbursed for expenses are all factors in these high drop-out rates and this can cause a trial to be delayed or even cancelled. It is crucial to keep subjects motivated and part of this can be achieved through efficient management of travel and other expenses.

Specialized clinical trials travel services were developed more than a decade ago. The demand for these services grew as it became apparent that CROs were struggling to manage travel and expenses for their trial subjects. Confidentiality rules and regulations stipulated by regulatory bodies such as the FDA and EMA meant that the sponsor could not access specific information on subjects, and this in turn meant that it was extremely difficult to arrange the reimbursement of clinical travel costs and other expenses with the participants.

The solution was that the travel management company (TMC) would intervene between the investigating site and the sponsor and, as they are classed as independent organizations, the subjects were given the choice as to whether to use the service. Those who did were able to contact the service provider directly. As the service is optional and is operated in conjunction with preapproved travel and expense guidelines, Institutional Review Boards (IRBs) are satisfied that the subjects are not being enticed to use the service.

By assigning codes for the subject and the study in place of personal information, travel is organized on the subject’s behalf. All the bills are sent directly to the TMC, where they are desensitized and then charged back to the sponsor. The sponsor’s corporate credit cards cannot be used for any element of the travel reservation process, as the details of the subjects would appear on the credit card bills.

To guarantee that there is no leaking of personal information, the corporate accounts of the TMC are used for all billing, reimbursement and reservation processes. Using a three-stage manual check process, information is desensitized and then reported back to the sponsor, who are only able to see the subjects ID’s, dates of booking, types of travel and cost (they are not able to access specific information on subjects). This level of reporting allows the sponsor to maintain control of costs and to ensure the subject IDs correspond with dates of clinic visits.

Payment of Expenses

Expense reimbursement is a further aspect of the service which allows a TMC to pay subjects any out-of-pocket expenses or stipends directly to them. This takes the burden of administration away from the CRO, who have embraced these services since they became available because they take care of handling the subject reimbursement and also saves them from having to deal with potential tax issues while managing expenses.