By Ann Neuer 

April 21, 2016 | Clinical Informatics News | 2016 Best Practices Awards | Retaining patients in clinical trials is notoriously difficult, and if those trials are for rare diseases, retention is even tougher. That’s where Clincierge comes in, a young Philadelphia-based company focused on providing concierge-type services to patients to ease what can be a substantial burden for clinical trial participants—traveling to and from the investigative site. Their efforts to improve patient retention grabbed the attention of the judges of the 2016 Clinical Informatics News Best Practices Awards, who named Clincierge the winner in the Study Startup and Design category. Their winning entry was announced at the recent Summit for Clinical Ops Executives (SCOPE) in Miami, Florida.

Clincierge’s entry described how facilitating trial participation, particularly for rare disease clinical trials, can require the drawing of patients from wide geographic areas, often so far from sites conducting the studies that airplane transportation is needed. Such was the case for a Phase III study for an RNA interference (RNAi) therapeutic that was recruiting in 18 countries in order to reach a targeted enrollment of 120 patients who would be followed for 23 months, on average. As part of this effort, patients would be required to travel every 21 days for up to 33 visits each, generally by air.

“We want to swing the needle on compliance,” says Scott Gray, CEO. The case study detailed in their winning entry explains how Clincierge is making this happen. “In the case of rare disease, there is often just a handful of sites in each country able to perform complex studies, making it difficult to find patients nearby. As a result, patients may have to travel hundreds of miles, so making it convenient for them is critical for retention, and ultimately, for compliance,” Gray says.

To handle the logistics of travel, Clincierge used 17 “clinical concierges”, who live in the participating countries, collectively speak 20 languages, and were trained in the particulars of the study. They made all of the arrangements, including picking people up at home and transporting them to the airport, and having a car waiting at the other end to whisk them to a hotel or to the site. Major travel costs were handled upfront and minor patient-incurred out-of-pocket expenses, such as reimbursement for meals, were quickly reimbursed.

A web portal in all necessary languages was designed especially for the study, but since many patients lacked internet access or were not tech savvy, telephoning Clincierge coordinators via toll-free numbers was the popular alternative. In fact, Clincierge found that 99% of patients and their caregivers preferred making phone calls rather than use the internet.

The out-of-pocket spend for airfare, hotel, and ground transportation exceeded $900,000, an average per-patient cost of $8,400. With Clincierge handling all of the travel planning and logistics, the overall time saving was 3,500 hours, translating into approximately 32 hours per patient.

Prior to bringing Clincierge on board, the sponsor was considering moving the patients to the various sites’ locales for the duration of the trial. But the founders of Clincierge, who are experienced in the events management industry, believed that taking a different tactic—using clinical concierges—was more in keeping with the trend toward patient-centricity in clinical trials.

“People have responded to this white glove, high touch service. We know this from the very low drop-out rate, less than 5%, a number that has persisted throughout the trial,” says Zac Carr, director of strategy & business operations. He explains further that sites using the Clincierge service over-enrolled and did so faster than competitive sites that did not use the service.

This model has application for many types of studies, beyond those for rare diseases. For example, patients who might qualify for an Alzheimer’s trial, or children with juvenile diabetes might live in areas conducting those clinical trials, but lack transportation. This is an opportunity for Clincierge, which is currently handling transportation services and the associated logistics for 17 studies across the globe. And to document how this approach is tied to better retention, the company is gathering anecdotal information from patients who have used the service, and ultimately plans to develop metrics.

Sponsors sometimes experience sticker shock when they hear about the cost of using Clincierge. Gray explains that they often have not considered these costs, “but those costs are already there. Sponsors need to think about the high cost of patients dropping out of studies, and the impact on study timelines. And if enrollment isn’t met, there’s also the cost of issuing change orders to extend the timeline and having to open rescue sites. This means they are delaying getting to market and recovering their R&D investment. From that perspective, clients assess our service as cost neutral,” Gray says.