Regardless of size, sites can implement many patient-centric changes without significant costs, and inexpensive ones can actually have a very positive impact, according to DM Clinical, a U.S. site network that’s earned praise for its lower-cost, data-driven approach to putting patients first.

DM Clinical, which encompasses 12 sites nationwide and is headquartered in Houston, earned the Society for Clinical Research Sites’ coveted Excellence in Patient Centricity Award last year, an accolade sponsored by close partner Sanofi, for its successful patient centricity program that was kicked into high gear during the COVID-19 pandemic.

The network elevated its efforts to be patient centric when critical communication gaps were discovered during the pandemic, a time that saw it go through exponential levels of growth, says Hera Arham, director of marketing and patient engagement. DM identified a critical issue during this time: High numbers of potential participants were signaling interest in taking part in trials but there was no real-time follow-up occurring, resulting in missed opportunities and the need to update infrastructure to sustain the network’s growth.

This directly led to the assembly of a patient engagement team whose job was to ensure calls were being answered and directed to sites or recruitment teams. Additionally, data were collected through first-visit, mid-study, end-of-study and phone screening surveys as well as patient focus groups, to isolate issues patients were having by site. In the first six months, this initiative and focus enabled the network to answer more than 10,000 calls and resolve 1,000 patient issues that would have otherwise been missed. And it opened their eyes to the power of data and key performance indicators in patient centricity, Arham says.

The utilization of data and reliable metrics has now become an integral component of the site network’s patient centricity strategy, Arham tells CenterWatch Weekly, with the patient engagement team “constantly assessing, improving, monitoring and reporting on the end-to-end patient experience.”

“The first step is analyzing the patient journey by communicating directly with trial participants,” she advises. “It’s a combination of collecting data through surveys, conducting focus groups and a dedicated patient engagement team that acts as a resource to ensure the same consistent-quality patient experience across the board. Data helps shift culture because it tells a story of how we as a team need to improve processes or remove barriers for patients.”

According to Arham, the approach has led to a 97 percent patient satisfaction score, a doubling in the amount of word-of-mouth referrals last year and a diversity rate of more than 48 percent across all of DM’s trials, which she says is higher than the industry standard. In addition, DM’s vaccine trials now boast more than 50 percent diversity, she says.

One critical aspect of DM’s program is the “patient liaison,” a staff position tasked with talking to patients daily, building connections with them and ensuring they are satisfied. The network has implemented it at every site and even developed a corporate training program for it. These personnel greet patients, regularly update them on wait times, offer snacks and drinks as they wait and focus on ensuring patient comfort, such as by helping them connect to WiFi.

DM Clinical uses metrics to evaluate its operations and creates focus groups based on issues discovered. For instance, it may put together a focus group of parents if a site is having trouble enrolling pediatric patients, bringing in both voices of parents whose children are already enrolled and parents who decide not to enroll. They also assemble “organic” focus groups involving random participants that have taken part in different trials of vaccines and therapeutics.

Arhem recalls one mother in a focus group whose toddler was a participant in one of DM Clinical’s trials. The problem they had, the mother explained, was that the site — a clinic that served both adult and pediatric patients — wasn’t kid-friendly in the slightest, leaving her child bored during their four-hour site visits.

The DM team created a simple two-page coloring book centered around “Matt the Meercat,” a character who teaches children to color and properly wash their hands during the pandemic. The DM team came up with the artwork in-house, bought crayons and used the material to occupy pediatric patients once they received IRB approval.

“When you’re letting the patient lead patient centricity, these small changes connect the dots for them in real time and don’t have to cost a lot,” she said.

For sites looking to improve their patient centricity, Arham recommends gathering data as a starting point, even if it’s only a simple methodology like Survey Monkey or Google. “The research method doesn’t need to be fancy,” she says.

“Data tells you a story and keeps patients involved in the process when you are looking to build trust within communities. They feel more integrated with the entire patient journey and that data eventually helps lead to a better study process,” she said. “It also helps open up conversations with sponsors to help design more inclusive protocols.”

But without site centricity from sponsors, patient centricity is a tall order, Arham cautions. Sanofi, a close partner of DM Clinical, strives to help and listen to sites through its Sanofi Makes Investigators’ Lives Easier (SMILE) program, which it unveiled in May 2018.

Brought on in part by an unsatisfactory ranking in CenterWatch’s 2017 Global Site Relationship Benchmark Survey (CenterWatch Weekly, Jan. 1, 2020), the program is designed to better support sites and get their input on billing, protocol design, recruitment, training, startup and other areas. Sanofi attributes a dramatic shift in its site-perceived reputation ranking — going from the 11th spot in 2017 to number one in 2019 and 2021 — to SMILE. This boost, as well as Sanofi metrics, demonstrate its great success.

For example, in 2022, the program helped Sanofi achieve more practical, patient-friendly protocols and brought together 147 patient advocacy groups in 33 countries to help inform and optimize every trial across the company’s portfolio. This included the identification of endpoints, patient-reported outcomes, simplified schedules of events and digital approaches, say Sanofi’s Victoria DiBiaso, vice president and global head of patient informed development/health value translation, and Megan Heath, head of clinical study units, Europe.

In addition, Sanofi’s attention to its sites has managed to reduce its procedures per protocol by three on average and reach a median of 38 days saved on trial startup per country, according to internal company data, they say.

SMILE also enabled Sanofi to adeptly and quickly implement decentralized trial methodologies at sites as the pandemic began by adding standard wording in protocol templates.