In the patient-centric conduct of clinical research, ROI (return on investment) is boosted significantly by providing patient travel services. An article from the NIH (National Institute of Health) remarks that: “…patients often are unaware of the possibility of enrolling in a clinical trial. If they are aware of this opportunity, it is often difficult for them to locate a trial. Patients may reside far from study centers; even the largest multicenter trials can pose geographic challenges for those wishing to participate. Moreover, depending on the number of clinic visits required by the study protocol, significant travel and time costs may be associated with participation.” 1 There are a plethora of pain points with patient engagement in clinical trials, and extending patient travel options benefits all stakeholders.
At the site and sponsor level, advantages to offering transportation to participants in clinical trials include:
- Patient retention, with adherence to study protocol visit schedule
- Faster enrollment, since patients are able to attend screening visits sooner and may commit to the study knowing they have travel support
- Timely enrollment, reducing the overall study cost
- Reduced burden on sites, since there are less missed appointments to re-schedule and the patients do not necessarily rely on the site for travel coordination
- Improved quality of data, since having a travel coordination service outsources is akin to having another CRC (clinical research coordinator)
Many times, sites are the go-between for travel or travel related issues. With a vendor in place, the site is free to focus on patient treatment and clinical research.
The primary hallmark of a responsive patient travel provider is simple in its elegance: they think like a CRC. Understanding the day to day responsibilities and tasks that clinical research coordinators face means that there is knowledge of the intricacies of protocols and the importance of quality data, safety, retention and compliance. This requires superior communication that allows for a consistent flow of pertinent information. There is no one-size-fits-all approach when it comes to patient travel, since studies and participants require varying modes of transportation and affiliated medical needs. Efficient and streamlined support of travel, therefor, must be highly customizable, with itineraries being tailored to a patient’s specific situation.
“You really need to have an experienced travel team,” advised Al Peters, Vice President of Elligo. “Travel program coordinators need to understand protocol, the visit schedule, as well as the physical and or cognitive implications that may come with the indication. These all effect the way travel is completed.”
Travel vendors frequently have daily communication with the patient, so understanding the impact the safety to the patient and crucial data points is imperative. Patients may also ask questions about the study, drug, treatment or medical device, or other compliance questions; travel coordinators need to recognize what is within their purview to answer and to whom to direct the patient in the event they are not delegated to provide the answer, per the delegation of duties at the site level.
There are three steps for adding travel to a study:
- Step One: Preparing Necessary ICF (Informed Consent Form) Language:
Language in the ICF needs to address what services are being provided to patients, compensation details including who is covering the cost, travel options being offered, the type of reimbursement service and stipend structure (if applicable). - Step Two: Setting Up the Process:
Choose a travel vendor that can responsively run the transportation program for your clinical trial. The vendor prepares forms and patient-facing collateral (welcome packet, reimbursement reports, etc.), all which must be submitted to obtain IRB/EC (Institutional Review Board/Ethics Committee) approval. The specialists at this company must understand the AEs/SAEs (Adverse Events/Serious Adverse Events), the site dynamics and what questions to answer for patients. - Step Three: Systems and Reporting:
Systems to be implemented include a platform for travel bookings, submission of reimbursements, a task system to know when to communicate with sites and patients for future appointments, deciding if affiliated functions are patient-driven or vendor driven, and reports to send the sponsor that can show de-identified information. Sponsors require that information be sent via patient ID number, so a system is needed that can report on travel data that de-identifies patient details.
Once processes and systems are implemented, the ROI and positive financial impact can be calculated.
“An easy way to calculate the ROI is to come up with the average cost of the trial, end to end. A figure of $30 million is not unheard of for a global, Phase III trial,” said Al. “Look at the duration of enrollment as well as the trial to calculate the average monthly run rate. Look at the number of patients and divide by the length of enrollment. If you take into account that there are a number of patients who would not participate, but for the travel program, the cost saving can easily be calculated based on the reduced timeline of enrollment.” (For an in-depth view of patient travel and calculating ROI, download the webinar). Other benefits include a measurable increase in the quality of data and overall retention and compliance.