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  4. Benchmarks for Diversity in Oncology Clinical Trials: An FDA - ACS Hybrid Symposium - 10/16/2024
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Workshop | Mixed

Event Title
Benchmarks for Diversity in Oncology Clinical Trials: An FDA - ACS Hybrid Symposium
October 16, 2024

Co-Sponsored by the Oncology Center of Excellence and American Cancer Society (ACS)

Date:
October 16, 2024
Time:
8:30 a.m. - 2:45 p.m. ET
Organized By:
Organizer

Twitter: #FDAACSSymposium24

Background

The Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and the American Cancer Society (ACS) are co-sponsoring a symposium focusing on setting benchmarks for diversity in oncology clinical trials. This symposium will focus on the identification of reliable data sources for characterizing the distribution of a cancer across demographic subgroups of the affected population in the U.S., describe methodology to use population data to set enrollment goals in oncology trials, and discuss clinical trial design and conduct considerations to implement diversity goals.

The FDA’s OCE has a dedicated program to improve the diversity and representativeness of participants in oncology clinical trials. In June 2024, the FDA published a draft guidance recommending that sponsors submit Diversity Action Plans for each trial intended to support FDA approval that specify enrollment goals and the measures to achieve those goals, to address the continued lack of diversity of trial participants. The OCE led the development of this guidance and the oncology divisions have received the majority (>80%) of Diversity Plans submitted to the Agency to date.

Key challenges for setting and implementing FDA’s policy on diversity planning include evaluating fit-for-purpose data sources to identify appropriate benchmarks for demographic diversity and representativeness for a specific disease indication, applying methodology that helps convert these benchmarks to attainable enrollment goals for a clinical trial using U.S. population-based data, and accounting for the non-US population enrolled in most oncology trials. Addressing these challenges is a priority for the OCE as new statutory mandates require that sponsors submit Diversity Action Plans for all phase 3 or other pivotal clinical trials, specifying enrollment goals disaggregated by race, ethnicity, sex, and age group.

Broad stakeholder discussion on practical approaches to address the above challenges and to meet the requirements for Diversity Action Plans.

Meeting Goals

  • Define data sources for benchmark setting for oncologic diseases
  • Define methods to apply population-based demographics (race, ethnicity, sex, age group) to clinical trial setting to ensure representativeness
  • Discuss clinical trial design and conduct considerations to achieve diversity goals

Symposium Materials

Contacts

Caitlin Drew, MSN, RN
Senior Health Scientist
Oncology Center of Excellence (OCE)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Caitlin.Drew@fda.hhs.gov

Event Materials

Title File Type/Size
Symposium Bios 10112024 pdf (641.35 KB)
Final Agenda 10112024 pdf (209.24 KB)
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