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International Clinical Trials

Soothing Recruitment and Retention Headaches the Logistical Way

Specialised 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 participants, and this in turn made it extremely difficult to arrange the reimbursement of travel costs and other expenses with the subjects.

Travel Management Company

The solution was that a travel management company (TMC) would intervene between the investigating site and the sponsor and, as they are classed as independent organisations, participants were given the choice as to whether to use this service or not – 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 participant and the study in place of personal information, travel is organised on the subject’s behalf. All the bills are sent directly to the TMC, where they are desensitised 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 participants 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. Employing a threestage manual check procedure, information is desensitised and then reported back to the sponsor, who is only able to see the subject’s IDs, dates of booking, types of travel and cost – it cannot access other, more specific information. This level of reporting makes it possible for 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 participants any out-of-pocket expenses or stipends directly to them. This takes the administrative burden away from the CRO.

CROs have embraced these services since they became available, as they not only take care of the handling of subject reimbursement, but it also saves them having to deal with potential tax issues with managing expenses. In many countries, there are tax implications in terms of sponsors sending money to CROs to reimburse participants’ cash payments. A TMC can ensure that the subjects are the first and only recipients of the payments, which are sent straight to their bank account by electronic transfer. The expense report is then desensitised and sent directly (electronically) to the sponsor.

Communication Equals Confidence


Specific agents are allocated to each study, allowing the subjects to become familiar and comfortable. Electronic profiles, which are in-line with data protection and also payment card industry-compliant, are used to keep participant information up to date. An agent can gain access to these profiles with a few key strokes. This allows reservations and expense reimbursements to be processed quickly with minimal inconvenience to the subject.

When organising their travel arrangements, proactivity is key. Often, study protocols and timetables only focus on the science and not the travel times involved. One day on site can mean three days’ travel time for subjects, depending on the length of appointment and availability of transport to fit around that. Through viewership of the protocol, the study schedule can be humanised, which means participants know the exact time commitment required before joining the study. Communication of the actual time expectations – not just the amount of visits – at enrolment stage can result in a higher retention rate.

A travel management service is seen by the subject as a neutral party, and this generally means that they will communicate both freely and willingly – which allows the TMC to help them and, in turn, maintain their confidence. Each requirement is contemplated individually and every aspect and detail of the operation, from home to clinic, is arranged for them. For example, air travel can be unnerving for participants who require special care and assistance, such as those in wheelchairs and those who need access to oxygen. By liaising with airlines and using established partnerships, a TMC can ensure their travel is as seamless as possible. If a subject requires specialised medical care while travelling, arrangements can be made for road or air ambulances, facilitating optimum comfort and medical care for the journey.

Multi-Site Studies

Conducting multi-site studies can often be a daunting task, from both a logistical and budgetary viewpoint. This is particularly true in emerging markets, where there are often cultural differences and language barriers to overcome. By utilising the services of a network of global partners, it ensures the service providers can draw on valuable local knowledge, such as familiarity with travel requirements for the customs unique to that region.

For example, during one trial, subjects from Paraguay were happy to travel by ferry from Monte Video to Buenos Aires and back again in one day, in order to receive infusions. In the same study in the US, in order to be at the site first thing in the morning, participants arrived at the town where they were to receive their infusions the evening before. They spent all day there before departing for home. In Russia, the same trial allowed participants to relocate to the city of their trial site for the duration of the research, due to a lack of public transport infrastructure.

This level of knowledge, combined with a study timetable and details of site locations, allows for effective travel and expense budgeting for global and multi-site trials. Additionally, local currency expense reimbursements and all travel arrangements made using global partners are billed centrally: this offers research sponsors consolidated financial data from one reporting system and immediate visibility of study expenditure.

Rare Disease Trials


Subjects taking part in rare disease trials can often be travelling from many different countries – or indeed long distances within a country – to just a handful of sites. Advance planning of logistics is key to keeping control of costs. It is wrong to assume that travel between countries that are close in proximity will result in the best value for money.

A travel management service can help with budgeting in these cases. Often, relocation may be a more cost-effective option than regular cross-border travel. Relocation can also be less of an ordeal to the subject than a gruelling travel schedule that might last a couple of years. A travel management service with clinical expertise will have the ability to help with relocation services.

A common error when planning trial logistics can be to underestimate the size of a country. Certain studies, including those researching rare diseases, may only have three or four sites that are suitable for testing in any given region. It is easy to assume that domestic travel is relatively straightforward and cost-effective – but this is often not the case.

Pre-Empting Problems


During the life of a study, one of the largest benefits that such a service brings is that all members of the team dealing with subjects are trained to listen carefully to every participant, and report their concerns or potential reasons for missing study visits before it actually happens. The reasons for dropping out of a study do not usually spring to mind.

For example, one subject could not wear a seatbelt due to the pressure it placed on them. The car company used for airport transfers explained that if the participant did not wear their seat belt, the driver would be fined should they be stopped by the police. After a consultation with the TMC and the sponsor, it was agreed that the sponsor – with the approval of the IRB – would pay any fine in the event of the driver being stopped.

In another case, one family with two children on a rare disease paediatric study would travel by plane and then rent a car to get to their nominated site for infusions. On arrival at the airport, the car rental company would allow the renters to choose any car, of a certain size, from a row of vehicles with the theory that the renter would get to try any car they liked. While the appeal of any car would bring a smile to many faces, in reality this procedure meant the family then had to wait for child seats to be fitted, which added a delay to an already stressful journey. On finding this out, the TMC was able to seek permission to deviate from the study travel policy, and move to a car rental vendor who would have the car pre-fitted with child seats when they arrived – thus reducing stress and helping study retention.

The benefits of outsourcing these crucial aspects of clinical trials are numerous. Ultimately, the sponsors retain control of costs and receive meaningful reporting. The CRO has a greatly reduced amount of administration, removing the hassle of organising subjects’ travel and reimbursing expenses and thereby allowing them to concentrate on their primary role.

In addition, improved budget control and cost savings can help the sponsor reduce expenditure through a study schedule that ensures travel can be effectively planned in advance. This, in turn, ensures smooth travel arrangements – leading to improved continuity in studies, happier and more motivated participants, plus a reduced risk of missed appointment visits or subjects leaving a study early, which are both an inconvenience and expense to the sponsor.

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Franc Jeffrey established EQ Travel Management in 2011 after 25 years’ experience in the international business travel sector, with the aim of bringing transparency and clarity to the industry by championing an innovative new fee system. He pioneered the first specialised clinical trials travel service of its kind 15 years ago, after identifying demand for a bespoke service. Franc’s international experience and hands-on approach leave him well-versed in globalising travel programmes and also well-placed to help CROs influence change, while always adopting best-in-region practices. EQ Travel have offices in Edinburgh, London and Boston.
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