FDA’s Oncology Center of Excellence initiative aims to expand clinical trial access
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The FDA’s Oncology Center of Excellence has launched a public health initiative designed to improve access to clinical trials of oncology medical products for historically underrepresented populations.
The Oncology Center of Excellence (OCE) Equity Program will include policy, research and education components.
The FDA formed OCE’s Project Equity in 2021 with a goal of addressing the underrepresentation of racial and ethnic subgroups in clinical trials.
The OCE Equity Program — introduced in May — will extend this effort to improve clinical trial access for residents of rural areas, older adults, sexual and gender minorities, and people with economic, linguistic or cultural obstacles to health care services.
“Even before the formation of Project Equity, FDA oncology staff worked with many stakeholders — including the American Association for Cancer Research, [ASCO], researchers, patients, statisticians, physicians and industry representatives — to develop recommendations for specific steps that developers of clinical trials could put in place to improve enrollment of diverse racial and ethnic groups,” Nicole Gormley, MD, associate director for equity advancement at the OCE, told Healio. “These discussions resulted in a proposal for diversity plans that would prospectively outline the research team’s strategy to collect and analyze data from diverse patient populations to better understand how race and ethnicity are associated with patient outcomes.”
OCE staff worked with three medical product centers at FDA to create draft guidance, titled “Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials.” The agency released the draft guidance in June.
Additionally, the Food and Drug Omnibus Reform Act — passed in 2022 — called for drug sponsors to submit diversity action plans for investigational device exemptions and other premarket applications.
“Such plans must include enrollment goals by race, ethnicity, age and sex,” Tamy Kim, PharmD, director for regulatory affairs and policy at the OCE and co-director of the OCE Equity Program, told Healio. “The requirement to submit a diversity action plan applies to clinical studies for which enrollment begins 180 days after publication of FDA’s final guidance.”
The OCE Equity Program will take a multifaceted approach to the effort of increasing access to clinical trials. The FDA cited the following objectives:
- Develop and promote policies to ensure adequate enrollment of historically underrepresented and vulnerable subgroups in oncology clinical trials intended to support FDA approval to evaluate any differences that may exist across the population.
- Engage and collaborate with internal and external stakeholders on research, policy and educational initiatives to promote access to and advance equity in clinical trials.
- Conduct and present analyses of data generated through clinical trials and other data sources to evaluate outcomes across subgroups.
The OCE also has launched other initiatives designed to improve cancer care and eliminate disparities.
Project ASIATICA is intended to improve care access for patients in the Asian American and Native Hawaiian/Other Pacific Islander populations and raise awareness about the unique challenges they face.
As of 2020, more than 20 million people who identify as members of these populations lived in the United States. Cancer is the leading cause of death in both.
Project Silver — is intended to improve representation of older adults in cancer clinical trials. As the U.S. population ages, cancer incidence among individuals aged 65 years or older is expected to increase by 67% between 2010 and 2030.
Reference:
- FDA. The OCE Equity Program. Available at: https://www.fda.gov/about-fda/oncology-center-excellence/oce-equity-program. Accessed July 26, 2024.
For more information:
Nicole Gormley, MD, and Tamy Kim, PharmD, can be reached at oce-equity@fda.hhs.gov.
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