Decentralized research organization (DRO) Care Access announced it has expanded its partnership with Eli Lilly in order to broaden the representation in its cancer research to increase participation of minority populations (such as Black, Hispanic, and LatinX people). The partnership reportedly will seek to increase inclusivity among oncologists, PIs, patients, and other groups.
“Over the past decade, we have been committed to increasing enrollment of racially and ethnically diverse clinical trials, including educating physicians and patients about the importance of diversity and partnering with organizations dedicated to expanding representation,” said Amy Davis, senior director of oncology clinical development with Lilly. “This is critical for an illness like breast cancer in which women of color have been historically underrepresented in clinical trials. Our work with Care Access, an organization equally committed to increasing representation of minority group members in clinical trials, brings us one step closer to achieving these diversity goals.”
Lilly will work with Care Access on its Phase III breast cancer study, dubbed eMonarcHER, which is evaluating the safety and efficacy of Abemaciclib (LY2835219) in participants with hormone receptor-positive and human epidermal receptor 2 positive, high-risk, early breast cancer who are taking hormone therapy after surgery. Cancer trials have historically under-enrolled patients from minority groups due to a number of possible obstacles, include geographical barriers, cultural differences, and a persistent distrust in health care.
By contrast, the eMonarcHER study has the stated goal of better engaging diverse groups of physicians and patients, in order to conduct research more fully representative of the US population. Additionally, according to the collaborators, the study has a more intentional focus on the recruitment of Black women with breast cancer, have a 40% higher mortality rate than white women.
Care Access representatives report that in order to boost enrollment, the organization will turn to members of its Patient Access team to establish and foster local community partners (including healthcare systems, physician groups, diversity-focused groups, advocacy groups, and community centers serving underrepresented minority populations.
According to Care Access, the partnership will build upon the two organizations’ previous work on COVID-19 trials, taking a three-pronged approach:
- Care Access will forge partnerships with surgical and medical oncologists in underrepresented minority groups to serve as PIs for the trial, helping set up and run a research program within their oncology practice; this is intended to abate the administrative or regulatory burdens on physicians that come with running a research program.
- The organization will form community-based partnerships through its Patient Access team to better reach trial gatekeepers and patients.
- It will educate patients through its Patient Education team so they can make informed decisions on whether to participate in the trial based on their medical needs.
“We have the unique ability to deliver quality care to patients in their own communities through our Sites on Demand program, creating more access and encouraging participation of all populations,” said Ahmad Namvargolian, CEO of Care Access. “While there’s been a 40% decline in breast cancer deaths over the last 30 years, a stark mortality gap remains between Black women and Caucasian women; it’s absolutely critical for our industry to address these hollowing disparities.”
“We are confident in our ability to expand patient access to deliver lifesaving treatments to patients faster and are excited to partner with Lilly on eMonarcHER to increase representation in clinical trials for minority group members immediately and for decades to come,” Namvargolian added.