When Persephone Biosciences set out to map the cancer microbiome, it knew it wanted to capture data from a more diverse population than is typically seen in oncology clinical trials. That goal led Persephone to partner with Curebase to bring the study to participants using a decentralized model.
Curebase is working with Persephone to collect stool and blood specimens from 350 colorectal cancer patients and a further 1,000 healthy people who are categorized as either low risk or high risk for the disease.
The partners want at least half of the participants to come from diverse populations. If they hit that goal, Stephanie Culler, co-founder and CEO of Persephone, thinks the trial will be one of the most diverse ever reported. That matters for a range of reasons, some of them specific to colorectal cancer.
“The disease disproportionately impacts minorities,” said Tom Lemberg, founder and CEO of Curebase. “African Americans are 20% more likely to get and 40% more likely to die of colorectal cancer. Cancer research, in general, is plagued by diversity issues as most of the research participants tend to be affluent urban Caucasians, which do not represent the demographics of many cancers.”
Enrolling a more diverse population could have far-reaching consequences. Persephone is trying to make medicines that work for everyone, said Culler, but it needs “to have representation from everybody in order to do that.”
As it stands, representation is lacking. “These communities have been underrepresented, especially in the microbiome field. There are barely any data sets that cover them,” said Culler.
Persephone identified decentralized clinical trials (DCTs) as a model that could help it generate datasets that are more representative of the patient population. The focus on DCTs reflects Persephone’s analysis of the barriers that have traditionally limited the diversity of clinical trials.
“One of the barriers to achieving real health equity has been access to clinical sites,” said Culler. “Many of these populations can't take a day off of work to participate in clinical studies and having to travel to and from sites can be challenging for anybody. A lot of these site-based models are not, I would say, in locations where some of these communities are.”
Having settled on the DCT approach, Persephone turned to Curebase, a fellow Y Combinator graduate. Culler was impressed by Curebase’s “sophisticated databasing” and compared the experience favorably to the process of working with some large service providers.
“We've worked with very large CROs before, and found them quite difficult to work with because they're very large companies, they move very slowly, and a lot of them don't have technologies to be deployed for decentralized trials. They don't have the software, as well the remote aspect, that Curebase has, and so we found that to be quite compelling when choosing Curebase as a partner,” said Culler.
Persephone is now in the study startup stage, contacting sites with the goal of enrolling the first patient in the study later in the first quarter. Enrollment could accelerate quickly from then on. Persephone aims to enroll most participants this year.
To hit that target, Persephone is partnering with organizations that can help improve diversity and plans to go to locations to discuss the study with religious organizations, community groups, and more. The “boots-on-the-ground approach” will run alongside a digital marketing campaign.
Curebase is exhibiting at this year's Summit for Clinical Ops Executives (SCOPE), taking place February 7-10 in Orlando, Florida, and online. The company also is presenting the session "Comparing Virtual and Traditional Sites in a Pivotal Medical Device Trial," Thursday February 10 at 9:25 EST. For more information about the event, visit www.scopesummit.com.