On September 28, 2021 Care Access, the world’s leading decentralized research organization (DRO), reported its expanded partnership with global biopharma leader Eli Lilly and Company (Lilly) to broaden patient access to clinical trials and increase representation of minority group members, including African American, Hispanic, and LatinX populations (Press release, Eli Lilly, SEP 28, 2021, View Source [SID1234590419]).
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Lilly has tapped Care Access in its phase III breast cancer clinical trial, eMonarcHER, designed to evaluate 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. Oncology clinical trials have historically under-enrolled minority group members due to geographical barriers, cultural differences, and a persistent distrust in health care. This study aims to engage diverse groups of physicians and patients to conduct research that is more fully representative of the U.S. population. There is a more intentional focus on the recruitment of Black women with breast cancer, whom we know when diagnosed with early breast cancer have a 40% higher mortality rate than white women. To increase enrollment, Care Access will utilize its dedicated Patient Access team to establish and foster local community partners including health care systems, physician groups, diversity-focused groups, advocacy groups, and community centers that serve underrepresented minority populations.
"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 at Eli Lilly and Company. "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."
Building on its work with Lilly through highly successful COVID-19 trials, Care Access will take a three-pronged approach: first, Care Access will create 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 lessens the administrative or regulatory burdens on physicians that come with running a research program. Second, Care Access will establish community-based partnerships through its Patient Access team to better reach trial gatekeepers and patients. Third, Care Access 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."
These enhanced measures to increase diversity for eMonarcHER is a step toward a more equitable future for all populations. Increasing representation of diverse groups in clinical trials helps to develop and deliver innovative treatments that make a meaningful difference in the lives of all people living with cancer.