As COVID-19 vaccines are being developed in all parts of the world, we are now seeing an unprecedented system taking place where clinical trials that use to take years are now taking mere months to come to fruition.
Still, such unique development does not come without barriers in place. The pandemic has, in essence, shrunk our world, as countries close borders to the point of virtually isolating themselves from their geographic neighbors. Thus travel, which had become collateral damage to the pandemic, has become restrictive and forced clinical trials to adapt to a more compact world. Yes, visits can still happen safely but combining central site visits and local doctor visits could be the way to go. And who better to coordinate this new normal in clinical trial travel than a Travel Management Company (TMC)?
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 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 or not 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 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 is only able to see the subject’s IDs, 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.
But in today’s shifting world, some things have to be observed through the prism of a pandemic, where the well-being of the test subject is paramount. This means budgets have been changed to allow for apartments over hotels, car rentals instead of Uber, etc. Most patient guidelines are now put in place to minimize the subject’s proximity to the general public in order to mitigate exposure.
We’re still seeing key visits at central sites as before, but now there are more sites local to the patients and the patient’s MD, not only cutting down on the risk of COVID-19 by keeping all patient travel local, but to help the study keep to its timetable. We’re also looking at options for hospitals where they can discharge patients early after procedures into a “clean” environment chosen so that the hospitals can get through their backlog. For this, we work with trusted apartment vendors and we instruct the cleaners and lay out the standards required for post hospital stay patients.
One of the first things we do when engaging with a pharma (Trial Sponsor) is ask for a copy of the study protocol. The protocol lays out the “road map” for the study as well as the site visits (days at clinic). Each one of those days on site can be three days away from home. For instance, an entire day visit in Houston for someone from Atlanta means travelling the day before, having the day on site and then likely staying the night of the visit. Once we read the protocol we ask these questions and lay out a patient expectation and associated budget. This helps the pharma understand what a one-day visit will cost but also, once we’ve created the patient guidelines, these can be used as part of the enrolment process. Something as simple as taking away the stress of the unknown and spelling out the exact participant expectations can bring us one step closer to the overly claimed, but often not achieved, goal of “patient centric clinical trials.”
Make no mistake, when it comes to clinical trials, travel was always a daunting task. But now we have to step up our game. For example, during one trial, subjects from Paraguay were happy to travel by ferry from Montevideo to Buenos Aires and back again in one day, in order to receive infusions. But as more and more countries shutter their borders, trials must adapt to working within their own geographic space. And in some countries, such as the USA, individual states are putting in place protocols for travelling from one state to another.
The good news is that by combining a study timetable and details of site locations, we now allow for effective travel and expense budgeting for clinical trials. Advance planning of medical trial logistics is key to keeping control of costs. It is wrong to assume that because we are unable to travel between countries that we no longer have to be budget-conscious. 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 or 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. However, very often precise relocation can be a more cost-effective option than regular cross border travel. Limiting travel 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.
Being proactive is key when organizing travel services for clinical trials. Often study protocols and timetables focus only on the science and not on 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. Through viewership of the protocol the TMC can humanize the study schedule, which means subjects know exactly the time commitment required before joining the study. Communication of the actual time expectations, not just the number of visits, at the enrolment stage results in a higher retention rate.
A travel management service is seen by the subject as a neutral party and this generally means that subjects will communicate both willingly and freely, 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 subjects who require special care and assistance, such as those in wheelchairs and those 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.
The benefits of working with a TMC on 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 by 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.
Reports indicate that 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. But as the world begins to stare down a pandemic, thanks to the outstanding work of our scientific community, it’s important to make sure that something as simple as travel restrictions does not slow down the progress.
Franc Jeffrey CEO of EQ Trave