CORe Initiative Looks to Transform Cancer Research Through Increased Diversity and Data Sharing
The CORe initiative is aimed at promoting inclusivity, reducing startup time for clinical trials, and facilitating data sharing to address recruitment and retention challenges in cancer research at community oncology sites.
Cancer research cohorts do not yet reflect the diversity of patients with cancer, as 85% of cancer trial participants are White males, explained Praduman Jain, CEO and founder of Vibrent Health and principal investigator in the National Institutes of Health All of Us Research Program, during a session at the Association of Cancer Care Centers’ (ACCC) Annual Meeting & Cancer Center Business Summit (AMCCBS) in Washington, DC.1 Further, African Americans and Hispanic Americans make up 13% and 16% of the US population, respectively, but less than 5% and 1% participated in clinical trials, respectively.2
To help address this problem, the Community Oncology Registry (CORe) was developed in collaboration with the ACCC Community Oncology Research Institute, St Elizabeth Healthcare, Penn Medicine Lancaster General Health, and Wake Forest University. The primary goal of CORe, according to Jain, is to promote diversity and health equity in community cancer trials.1
Praduman Jain, CEO and founder, Vibrent Health
Image credit: Vibrent Health
“When you look at clinical trials, we've heard a lot about how starting up a clinical trial is one of the hardest things to do—from a cultural standpoint, from a training and education standpoint, and from a protocol development [standpoint],” Jain said during the session. “[It is also difficult] to build awareness with physicians and to build awareness with the participants and patients and their families. So, we started to think about what if we were to increase participation and the rate of participation in the trial by reducing the upfront startup time to help increase the likelihood of trial participation.”1
Jain explained further that the issue of representation in cancer clinical trials is crucial to effective cancer care, as a lack of diversity in trials leads to research that is not generalizable and novel therapies that are only accessible to a limited group, Jain explained. These limitations, in turn, lead to the development of less effective treatments and worsening cancer outcomes within underrepresented groups.1
Jain noted that addressing how to reduce the trial protocol and upfront time and build a sustainable and durable regional infrastructure for the cancer research community were critical for the development of CORe.1
“We paid special attention to fusing datasets, such as social determinants of health datasets, clinical datasets from electronic health records, and also genomics,” Jain said. “There was a lot of discussion about perhaps doing genomics data collection [for] biospecimens, whether it was saliva or maybe some blood collections, which gets to the individual level with this data collected upfront. That can then enable clinical trial matching and other things.”1
To ensure broad inclusion criteria, CORe also expanded the definition of who is included in the cancer community, Jain explained. These expanded criteria included patients with cancer, cancer survivors, family members of patients with cancer or survivors, other caregivers for the patient, and persons who feel they may be at increased risk of cancer for any reason.1
Jain noted that his team conducted a small feasibility study to assess these broad inclusion criteria in practice and asked for several rounds of patient and provider feedback.1
“Whether it's an interventional trial or it's a drug development trial, you say, ‘Hey, I need 500 patients for this trial,’” Jain said. “So, what's the current practice? They go to academic medical centers, and they go to community oncology practices. However, community oncology practices don't have sufficient infrastructure or sufficient number of patients. So, I'm sure everybody here is familiar with why so many clinical trials fail—it’s recruitment, and accrual is one of the biggest factors. Then the second factor is retention in long-term follow-up. So, this initiative is designed to address both of those issues.”1
For example, Jain explained if a researcher is looking for 500 patients with cervical cancer, any one community oncology practice may not have enough patients, so CORe makes a common infrastructure available. With this infrastructure, 100 oncology clinics across the country are able to recruit patients for this trial.1
“Your recruitment time is drastically reduced, and your likelihood of achieving your protocol and goals of recruitment go up, and the same thing on the follow-up side and retention side,” Jain said. “This was one of the key reasons that we did this.”1
Another key area to support the goals of CORe is data sharing, according to Jain. Through sharing deidentified data, trial investigators are able to learn from one another.1
“That [learning] happens through data sharing, and it happens through scientific publications. So that was the other goal of this initiative,” Jain said. “It's fully ready to start sharing deidentified patient data at the highest level of data security, privacy, and compliance, and it is approved by the NIH. [Also,] maybe some of you may be familiar with the new regulations of NIH around data sharing. It's required now by the NIH that every funded project has to have this. [CORe has] this infrastructure already ready to share fully deidentified data sets in a very responsible manner.”1
With all of these controls for data sharing, the study could be conducted within the United States, or it could be conducted outside the United States, according to Jain. This can open up further opportunities for getting a study off the ground faster.1
Additionally, Jain explained one advantage to CORe is it provides the type of resources that are commonly available to National Cancer Institute–Designated Cancer Centers, which have a lot of funding and a lot of digital tools at their disposal. CORe looks to level the playing field for community oncology practices.1
“Typically, a resource tool like this would not be available to a community oncology practice. But in the large cancer centers, this is commonplace. So that's where we learned [this] from—the academic medical centers and cancer centers,” Jain said. “We wanted to bring the benefit of this to community oncology practices so they can benefit from these investments that have been made at the national level by the NIH and other organizations.”1
Additionally, Jain noted that CORe is looking for additional partners from industry and community oncology.1
“We hope to have more partners on the biopharma side and the community oncology side, and to be able to then pursue more grant funding opportunities. That will hopefully help us to participate in many of these funding announcements that typically end up going to academic medical centers,” Jain said. “We have an opportunity here to collaborate and to intersect that funding. And, of course, that leads to publications and other things.”1
