FDA Oncology Center of Excellence Forms The OCE Equity Program

May 20, 2024

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On May 20, 2024, the FDA Oncology Center of Excellence (OCE) announced the formation of The OCE Equity Program. The new program expands Project Equity, continuing the Oncology Center’s work to improve access to clinical trials of oncology medical products for populations that have been historically underrepresented in clinical research.

The OCE formed Project Equity in 2021 to focus the Center’s longstanding efforts to address the well-documented underrepresentation of racial and ethnic subgroups in clinical trials. In addition to racial and ethnic minorities, the OCE Equity Program will continue the Center’s efforts to improve trial access for individuals who live in rural areas, sexual and gender minorities, and individuals with economic, linguistic, or cultural barriers to healthcare services. 

The OCE named Nicole Gormley, MD, and Tamy Kim, PharmD, as directors of The OCE Equity Program. Dr. Gormley Associate Director for Equity Advancement in the OCE, and director of the Division of Hematologic Malignancies 2 in the FDA Office of Oncologic Diseases. Dr. Kim is the OCE Director for Regulatory Affairs and Policy.

Project Equity and FDA Draft Guidance on Diversity Plans

In 2021, Project Equity worked with many stakeholders including the American Association for Cancer Research, the American Society of Clinical Oncology, 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. 

These discussions resulted 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. 

In April 2022, the OCE collaborated with the three medical product centers at FDA to issue draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.

The Food and Drug Omnibus Reform Act, passed in December 2022, required drug sponsors to submit Diversity Action Plans for phase 3 or other pivotal trials that are not bioavailability or bioequivalence studies. Device sponsors will also be required to submit Diversity Action Plans for Investigational Device Exemptions (IDEs) and certain other premarket submissions. Such plans must include enrollment goals by race, ethnicity, age, and sex.

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. 

OCE Equity Program Expansion

The OCE Equity Program seeks to advance equitable access to clinical trials for all patients with cancer through policy, research, and education. The goals of the program are to:

The program will include OCE’s Project ASIATICA, an initiative begun in 2023 to bring focus and awareness to Asian American, Native Hawaiian, and Other Pacific Islander patients with cancer, and Project Silver, a 2021 initiative to increase representation of older adults (65 years and older) in cancer clinical trials.

For Further Information: FDAOncology@fda.hhs.gov.