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Clinical trials endure high drop out rates due in part to long schedules, high travel costs and long reimbursement times. Outsourcing specialized clinical trial traveling services can help alleviate this concern by allowing sponsors to efficiently manage travel and other expenses.
As many as 30% of subjects taking part in Phase III clinical studies drop out. Grueling schedules, high travel costs and long expense reimbursement times are all factors in these high drop-out rates, which can cause trial delays or even cancellations. 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 have grown among the need to address the regulatory demands around subject confidentiality. A travel management company (TMC), as an independent organization, can navigate the regulatory pathways and access specific information on subjects, arrange reimbursement of travel costs, as well as other expenses with the participants.
As an independent service, subjects are also given the choice as to whether to use the service. Those who did can contact the service provider directly. As the service is optional and is operated in conjunction with pre-approved 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.
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. By using a TMC to handle such reimbursement, it means CROs don’t have to deal with potential tax issues while managing expenses. For example, in Poland if you receive monies as a company or individual, it must be declared to the tax authorities even if it’s a straight pass through expense.
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 PCI compliant, are used to keep subject information up to date., and are used by agents to make reservations and expense reimbursements.
Proactivity is key when organizing travel arrangements for subjects. When the sponsor provides the study protocol to the TMC, it can determine the travel impact on the patient that the visits require. The TMC builds a travel schedule around the protocol science that can be communicated to patients when they are thinking of enrolling in the study. By doing this, the patient knows their time expectation, along with the “scientific” expectation. For example, a one-day visit to a clinic can be three days when travel time is factored in. In one study, when the patients leave the clinic, they are radioactive and therefore not allowed to fly. Their one-day visit is followed by four nights in a hotel before travel is permitted. In this case, the protocol will say a one-day visit, but the real time involved is actually six--one night before, one day at the site and four recovery days.
A travel management service can be viewed by a study participant as a neutral party since they are invited to use the service and it is not required. This could allow them to communicate more to their agents to help them, which in turn can help build the participant’s confidence. For example, air travel can be unnerving for subjects who require special care and assistance, such as those in wheelchairs or who require access to oxygen. By liaising with airlines and using established partnerships, a TMC can ensure travel is as seamless as possible for the subjects. If a subject requires specialized medical care while travelling, arrangements can be made for road or air ambulances, ensuring optimum comfort and medical care for the journey.
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 utilizing the services of a network of global partners, the TMC ensures the service providers can draw on valuable local knowledge, such as familiarity with travel requirements relevant to 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 once day, in order to receive infusions. In the same study in the United States, subjects arrived in the town where they were to receive their infusions the evening before, in order to arrive at the site first thing in the morning, they spent all day there before departing for home. In Russia, the same trial allowed subjects 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 sponsor’s 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 countries or indeed long distances within a country to just a handful of sites. Advance planning of subject 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.
The TMC can help with budgeting in these cases. Very often relocation can 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 can 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 underestimating the size of a country. Certain studies, including rare disease studies, may only have three of four sites that are suitable for testing in any given region. It is easy to assume that domestic travel is relatively straight forward and cost effective, this is often not the case.
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 organizing subjects travel and reimbursing expenses, allowing them to concentrate on their primary role.
Additionally, improved budget control and cost savings can help the sponsor reduce expenditure through providing a study schedule that ensures travel can be effectively planned in advance. In turn, this ensures smooth travel arrangements, which leads to improved continuity in studies, happier and motivated subjects and a reduced risk of missed appointment visits or subjects leaving a study early, which are both an inconvenience and an expense to the sponsor.
Franc Jeffrey is CEO of EQ Travel, with offices in the United Kingdom and Boston, MA. He has over 25 years experience in global corporate travel. Franc can be reached at email@example.com. For more info, visit www.eqtravel.com.