Patient Travel Services that are Compliant with IRB and EC Regulations
Many sponsors who are new to the idea of implementing travel services are wary of the compliance regulations involved, and rightfully so. As with any element of a clinical trial, you never want to do anything that coerces a patient into participating.
On the surface it can seem like offering travel services is a biased incentive that goes against IRB and EC regulations, but this is not true! Travel services for clinical trials are becoming increasingly common and have proven to be critical to improved patient enrollment, retention, and satisfaction rates. However, there are several steps you must follow to ensure compliance if you choose to implement travel services as part of your study.
Step 1: ICF language
The language included in your ICF needs to address exactly what travel services are being provided to patients and what they are being compensated for. You should be sure to answer the following questions:
- Who is covering the cost?
- What types of travel services are being offered? (Flights, rail fare, gas mileage, etc.)
- What reimbursement services are being offered? (Are you reimbursing for meals on the road? Will you cap off the reimbursements at a certain dollar amount per day? Will you cover caregiver meals as well?)
- Will patients receive a stipend for participating in your trial in addition to travel services and reimbursements?
The more details you can offer, the better! The IRB and EC want to know that there is a logical reason for what you are offering, as relates to the study.
Step 2: “Setting up” Process
In order for the IRB and EC to give the green light for your travel program you need to create a handful of forms and submit them for approval. The forms you create should include a welcome packet for patients that clearly outlines what is being offered. You should indicate within this packet what sort of personal information you will need from the patients in order for the vendor to book travel. Any country in which you are conducting your trial needs to approve these packets.
You also need to put together official travel policies for approval. The policies should outline what level of fare you will be providing to patients (economy, business class, etc.), how many nights in a hotel you will provide, and how many rooms you will cover per patient. (This becomes relevant in cases where a patient may need to travel with a caregiver.) It is imperative that you are very specific in these policy documents.
To ensure complete compliance, it is recommended that you bring on a travel management vendor that can run the “setting up” process for your trial. A vendor with an experienced clinical background will be of the greatest benefit to you as they will understand the study protocol, visit schedule, and any physical or mental limitations that may come with patients for a given indication. With all of this in mind they will be able to craft a policy that best fits the needs of your trial.
A clinical trial-experienced vendor will also understand AEs/SAEs, site dynamics, and what questions to answer from patients. This can only enhance the validity of your trial once it is up and running, as you can be sure that even third party interactions are IRB/EC compliant. Travel vendors will be speaking with patients consistently. As a sponsor, you want to be able to trust these communications entirely.
Step 3: Systems and Reporting
Once everything is set up and approved it is the responsibility of the vendor to make sure that the proper systems are in place to facilitate your travel program. These systems include a platform for booking travel as well as one for patients to submit and the vendor to process reimbursements and stipends. Task systems are great for this because they know when to communicate with sites and patients for future appointments.
The systems that travel vendors use are able to quickly run de-identified reports that can be provided to sponsors at any time. This way you can accurately assess how your study is going at whichever intervals seem appropriate to you. How many patients are utilizing travel services? Of the services offered, which is used the most? How much money per patient are you spending on travel services? This sort of information can be easily provided to you and is extremely helpful in helping you assess the study at hand and plan for future studies of a similar nature.
Do you want to learn more about the benefits of working with a clinical trial industry-specific travel vendor? Read our white paper on this topic today:
Post by Maggie Kilgallon -
Maggie is a Marketing Coordinator at ClinEdge, BTC Network, and GuideStar Research. She assists the internal marketing team with content creation, conference planning, webinar management, external partnerships, social media strategy, and other marketing efforts.