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  1. Oncology Center of Excellence

Project Equity

Generating Evidence for Diverse Populations in Oncology

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Purpose

Project Equity is a public health initiative established by the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) to ensure that the data submitted to the FDA for approval of oncology medical products adequately reflects the demographic representation of patients for whom the medical products are intended. 

Why is This Important?

Project Equity aims to ensure that FDA approved medical products work for all. Project Equity works to improve access to clinical trials of oncology medical products for populations that have historically been underrepresented in clinical research such as racial and ethnic minorities, individuals who live in rural areas, sexual and gender minorities, and individuals with economic, linguistic, or cultural barriers to healthcare services. 

Access to potentially promising drugs in clinical trials

Clinical trials provide patients the opportunity to access potentially promising investigational treatments, which may be especially important when standard treatment options provide limited benefit or no standard treatments exist. For patients with serious and life-threatening diseases like cancer, quick access is important.

Generate data 

Clinical trials are the mechanism by which sponsors collect the data needed to evaluate the safety, effectiveness, and dosage of cancer treatments. It is important that clinical trial participants reflect the population that will use the treatment once it is approved by the FDA. Often, the data collected from diverse populations improves our ability to understand the disease and how it responds to treatments for a larger proportion of patients who eventually go on to receive the drug.

Project Equity Goals

  • 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.

Program Lead: Lola Fashoyin-Aje, MD, MPH, Associate Director, Science & Policy Program to Address Disparities, Oncology Center of Excellence 

Program Management: Jessica Boehmer, MBA, Regulatory Scientist, Oncology Center of Excellence

Contact: OCE-Equity@fda.hhs.gov

Additional Resources

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