Easing the Participant Burden in a Time of Complex and Demanding Protocols

May 16 2023  

It’s no secret that protocol complexity is on the rise, and with it, increased burden on trial participants – from more frequent and longer visits to further distances and greater expenses. We as an industry must simplify the participant experience and consider these impacts as a central part of upfront study planning and beyond.

Technology can be a key enabler of patient convenience, easing and centralizing tasks, increasing access and education and eliminating common causes for drop out. Sponsors who implement a comprehensive patient convenience program can build loyalty and trust amongst their patient community, and ultimately enable greater trial success.

Easing the Logistical Burden for Trial Participants

Getting participants to and from their visits is foundational to protocol adherence and trial success. However, travel is anything but simple, especially for trial participants who may be living with burdensome conditions. There are many variables throughout the life of a clinical trial – including unforeseen tribulations such as the pandemic and economic recessions – which can significantly impact a trial and participant’s ability to remain enrolled.

For instance, with the rebound of travel post-pandemic, food and lodging costs are reportedly up 8 and 9% respectively, with airfares and travel destination prices at all-time highs. While trial participants may not be traveling recreationally, there is high competition for travel and lodging with those who are. These complications are typically heightened when dealing with international travel. And with logistics as such an important part of trial operations, it’s critical to have a comprehensive program in place that is flexible, and scalable to meet the varying needs of participants around the world – whether arranging car services, flights and trains or travel visas, wheelchair accessible vehicles, non-emergency medical transport and other services.

Here’s an example of the impact a global travel network and regionalized expertise can have on a trial:

In a study Greenphire supported during the pandemic, a participant was travelling between France and Belgium to get to their trial site. When cross-border travel was locked down, our in-country travel agents immediately established a plan – executing the appropriate paperwork and arranging for two separate car services to facilitate the patient’s cross-border transportation. This plan ensured the patient arrived at the facility on time and returned safely home, allowing them to stay enrolled in the study and without placing added burden on the site.

Ultimately, life is complex and unpredictable and so is participating in a clinical trial. With a centralized, global travel program specifically geared towards supporting clinical trial participants, localized needs and nuances are addressed, out-of-pocket costs are removed, the weight of travel coordination is eliminated, and peace of mind is established for all stakeholders from participants and sites to sponsors and CROs.


Removing Financial Barriers to Clinical Research Participation

Financial toxicity is a central issue examined amongst patient advocacy groups – specifically looking at how we can alleviate financial burdens that may otherwise prevent participants from enrolling or staying enrolled in a study.

There are many potential expenses associated with participating in a clinical trial. Sponsors, CROs and sites want to reduce out-of-pocket expenses or at the very least make sure that participants don’t carry these expenses for a long period of time before they are reimbursed. If the trial doesn’t offer concierge services, typical out-of-pocket costs can include travel, parking, tolls, lodging, etc. However, there are also other life-related expenses that need to be considered, such as child and pet care or time away from work.

To address the questions that participants may have around expenses and reimbursements, Greenphire worked with CISCRP to develop A Guide to Costs and Payments in Clinical Trials.

When evaluating solutions and services to support patient convenience, it’s critical that expense reimbursement isn’t just solved for in a few markets. The financial management and payment program needs to be global in nature and scalable, with an extensive and proven infrastructure in place to ensure adequate execution and support.

Having the ability to support regional preference and patient choice, including offering various currencies and flexible payment options (e.g., direct deposit, digital wallets, virtual cards, reloadable debit cards and more) is essential to meet the needs of participants around the world. Enabling simple, real-time funds distribution removes the financial burden and keeps participants in the trial. Consistent and flexible payment methods help to build trust, allowing participants to feel more like a partner in research.

Additionally, you can’t just think about the payments from the patient point of view; it’s also important to consider the site workload. Streamlining the payment workflow can minimize the administrative burden for the site staff. According to the 2023 Patient Convenience Market Trends survey, Greenphire reaffirmed that sites utilize patient engagement technology largely to ease administrative efforts for site staff.


Using Technology to Drive Ongoing Patient Engagement

Core to removing barriers to participation is providing centralized and convenient access to trial information and tasks. As the landscape of research has evolved, there are a variety of ways and locations in which trial activity can be completed. While flexibility is a positive thing, if not executed properly, this can weigh on the participant, and in turn impact the overall trial.

To alleviate these concerns, more emphasis is being placed on the digital experience, to keep patients engaged and informed. Today, people have learned to rely on technology deeply in their daily lives, especially when obtaining information. The same types of tools and tactics should be available to participants in a clinical trial.

Participating in a clinical trial can be an uncomfortable or unfamiliar situation. Participants are put into this complex world that can be challenging to understand. As such, they want to be informed and included as a part of the research, which is why there is a need for consistent transparency and bi-directional communication.

For example, there is an added level of comfort if participants can easily access updates or information – such as travel itineraries, financials (balance & uploading of receipts for reimbursement), visit reminders and details, etc. It’s also important to provide this information in a flexible manner and allow participants to use the platforms they are comfortable with (whether a mobile app or via the web on a desktop, laptop or tablet). Using technology to gather information and provide ongoing resources to the participant, drives convenience, engagement, and more connectivity throughout their clinical trial journey.

Keeping consistent with the previous topics, participant-geared tools and services need to be designed with the site also in mind – streamlining their workflow and making it easier for them to support participants. Ultimately, a successful patient convenience program will ease the participant burden and provide centralized access to information and tasks, simplify site processes so they can focus on research and provide complete transparency for increased sponsor and CRO control and visibility.

At Greenphire, we’re passionate about developing innovative solutions to enhance the patient experience and drive efficiency across the clinical trial lifecycle. For more information about our solutions, check out these resources!

Ashley Leuthe
Associate Vice President, Product Management

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