At SCOPE 2023, four members of Inato's team presented on the advantages community-based sites bring to clinical research.
After several years of virtual conference attendance due to COVID, industry leaders finally came together this year at the 2023 iteration of the annual SCOPE conference. Conversations buzzed throughout the week as players in the industry once again got the chance to share with each other the innovations changing the trajectory of the clinical trial world. Inato was no exception. On Wednesday, February 8th, four members of the team presented on the advantages community-based sites bring to clinical research.
Inato’s Site Marketing Lead, Laurel Uballez, moderated a panel discussion between VP of sales, David Friend, Sr. Director of Business Development, Chris Kreitel, and Head of Oncology Strategy, Marcy Kravet. Led by metrics that wove a story of the challenges and solutions surrounding community based research, they broke down the underlying issues holding research back and the community based solutions possessing the power to propel it forward.
The Longtail of Sites: 5% of sites are running 70% of industry trials
Kreitel kicked off the panel by breaking down the metric driving the conversation of underutilized community-based research sites: Just 5% of sites run 70% of trials. The number reveals a disconcerting trend in the site selection process: sponsors return to the same, known sites time and time again, leaving a longtail of 95% of experienced research centers with few opportunities to offer their patients.
Kravet pointed to the underlying familiarity bias as a cause. If a sponsor doesn’t have an existing relationship with an unfamiliar site, the likelihood of choosing them plummets. This is perpetuated by the issue of data gaps. Due to a cyclical trend against community sites, the limited trial access results in less cumulative data on a site and a misperceived lack of trust while inflating the trustworthiness of a known site. This too has detrimental effects on the success of thousands of studies. “By going to the same sites over and over again we are stressing the patient populations and are unable to fulfill our obligations for our clinical trial requirements,” said Friend.
A Problem With Access: 74% of cancer patients receive care in the community yet in a recent study no trials were offered in 36% of physician-owned practices.
Uballez then shifted the conversation, turning to Kravet to provide insights into a key solution available for increasing patient access: bringing the trials to patients where they live. The relationship a site has with their community is a huge indicator of their ability to reliably recruit patients. Partnering with community sites that have strong relationships with their patients enables sponsors to minimize that risk and trust that they have the capability to dependably enroll. Kravet shared that community researchers tend to go the extra mile to truly prioritize the care of their patients, “Many of our sites report that they will open early or stay open late so that working patients can participate.” They have representative staff who may speak additional languages, they have community engagement programs, and they have an existing level of trust that increases the ease of recruiting willing participants.
Kreitel added that many of these unique qualities that allow for close patient-physician relationships also enable faster activation and enrollment. He shared, “We’re seeing enrollment that’s 2.2x faster. We ask our sites: “How is it possible that you’re enrolling so fast?” Their answer is: “They’re our patients. We have that trust so when we recommend a trial they’re more likely to listen.””
Engaging Underrepresented Populations: The FDA approval of 18 new oncology drugs in 2020, only 5% were Black and 6% Hispanic.
Sites with close connections with their communities are also capable of engaging with underrepresented populations. This is an immeasurable advantage yet many trials are taking place at academic sites that aren’t favorable for improving access to diverse patients. A redesign of the site selection process is critical. “If you do what you’ve always done, you’re going to get the results that you’ve always gotten. We’ve got to change the way we do things,” said Kravet.
Kreitel pointed to filling out the qualitative data we have on sites as an opportunity to do just that and disrupt the current, failing, approach. This means looking at more than location to identify sites with diversity capabilities or, better yet, letting those sites come to you. Kreitel referenced a previous trial that took place on Inato’s platform for RSV vaccines. A South Dakota site raised their hand for an opportunity to participate and was selected for the study. Their location’s demographic is 78% white yet, as the site began enrolling, the sponsor and Inato’s team quickly found that their patients were primarily Native American. Upon speaking with the primary investigator, he revealed that, as he was Native American himself, he had close ties to the community. He personally invested time in recruiting patients, dedicating himself to improving innovative healthcare options for his community.
The anecdote revealed an important insight: let the sites be the one to choose the trials that are right for them. They know exactly what they can offer and it isn’t something that can be measured in a typical data set. Kreitel suggested, “It’s as simple as [asking them]: what can you deliver?”
The panel ended on this notion: enable sites to choose their own opportunities, let them speak up on what they can offer, and unlock the advantages that follow. “We need to give community sites a stronger voice in the site selection process,” Friend explained. The approach influences the crucial component of timing, enabling researchers to find the study that is truly the right fit, at the right time for their patients. By letting community sites select the trials that work for them, we can cut down on activation and enrollment times and, more importantly, get patients the access to the medical innovation opportunities that they deserve.