Hear from site leaders on the value their community-based centers bring to clinical trials.
Despite proven access to patients, two Florida-based community sites have historically struggled to connect with large, global sponsors. Unfortunately, they are not alone in this. Many sites across the world with experience and patient access have difficulty participating in clinical trials. By removing barriers and enabling these sites to raise their hands for the trials that are best for them, we can increase patient access, reduce competition, and accelerate timelines.
Last week, Yadenis Jimenez, Site Director at VICIS Clinical Research and Robert Leon, Site Director at Bayside Clinical Research, shared the challenges they have faced when partnering with sponsors and strategies to overcome them during the Marcus Evans Evolution Summit.
For Leon, one of his biggest pain points when trying to partner with sponsors happens early-on in the process. He shared that more often than not, when he expresses interest in a trial and receives a CDA from a sponsor, after signing it and sending it back, he never hears from them again. “This is something that is really frustrating,” he said.
This is especially challenging for sites because once the sponsor reaches out, the site typically starts prepping for that type of trial, reviewing their database and looking to understand which of their patients would be eligible to participate. Leon shared that whether or not the sponsor is interested in working with his site, he would appreciate a response. This will dramatically improve the site’s ability to plan.
Both Jimenez and Leon see a large population of hispanic patients at their sites. However, they often have to overcome several hurdles when enrolling these patients in trials, the most common of which being a lack of translated materials.
“When we get a study and we know that we can do well - we have the demographics - but then the [Informed Consent Form] comes and it’s only in English,” Jimenez said. “That means you’re losing at least 50% of the population in our area and you’re losing out on valuable data”
Despite the challenges, Jimenez strongly believes that community-based sites like hers are the best positioned to engage diverse populations. When compared to large, academic centers, she said patients feel less intimidated and more at-home in her site. “Hospitals are a last resort,” she said. “They want to go to the doctors they know at community sites.”
When patients know and trust their doctors, they’re also more likely to remain engaged throughout the course of the trial. “When they hear that a site staff member speaks their language, sits down with them and gives them coffee, it makes them much more comfortable and more likely to keep showing up,” Jimenez said.
Before kicking off an Alzheimer’s trial, a global sponsor was looking to recruit more patients. They knew Florida was a target geography but believed they had access to all of the patients in this state through large academic centers. However, by partnering with Inato and allowing community sites with the right populations to raise their hands, the sponsor ultimately selected 8 new Florida sites for their trial, unlocking access to previously untapped patients.
Leon and Jimenez, whose sites were both selected in the Alzheimer’s trial, originally learned about it through Inato’s self-select tool. Upon sharing that they were interested in the trial, they immediately gained access to the CDA and once it was signed, they automatically received the protocol synopsis. “As soon as I had that, I could go to my team and start looking in the database to see which patients we have that are a match for the trial,” Leon said.
With this approach, a site can have patients lined up and ready as soon as they are selected for the trial. Inato further supports patient enrollment by helping the sites come up with their targets based on their database. “This helped us realize we could actually surpass expectations,” Jimenez said. “We were able to screen and randomize more patients. This process gives us credibility because it’s based on real numbers. It’s not based on a feasibility question of ‘Hey, what can you do?’”
The experience of VICIS and Bayside Research Center proves that partnering with a larger network of community sites, increases patient access, reduces competition, and accelerates timelines.
Inato is supporting community-based investigators by enabling them to bring the latest medical innovations to their patients, no matter who they are or where they live. With this approach, sponsors can allow sites to raise their hands for the upcoming trials that best suit their capabilities and patient populations. This in turn allows them to receive early insights and gain access to previously untapped populations.
“Sponsors, in my opinion, are missing out on sites like us,” Leon said. “We have the patients and I believe that a lot of sponsors would benefit from reaching out to sites like us. I challenge [them] to do that.”
For more information on how you can start engaging community sites, visit https://inato.com/