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.
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, Office of Oncologic Diseases
- Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
- Collection of Race and Ethnicity Data in Clinical Trials
- Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
- Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies
- Cancer Clinical Trial Eligibility Criteria: Brain Metastases
- February 13, 2020: “FDA-AACR Workshop to Examine Under-Representation of African Americans in Multiple Myeloma Clinical Trials”
- September 29, 2020: NHC Annual Symposium on the Science of Patient Engagement, “FDA Oncology Center of Excellence Initiatives to Advance Patient Engagement”
- November 18 & 20, 2020: two-part FDA/OCE Symposium: “Understanding Barriers to Oncology Clinical Trial Participation for Sexual and Gender Minorities”
- March 9, 2021: Reagan-Udall Foundation for the FDA hosted roundtable: “Generating Evidence for Racial and Ethnic Minorities During Development of Oncologic Therapeutics”
- May 26-27, 2021: FDA Science Forum, “Addressing the needs of underrepresented demographic subgroups in oncology”
- Fashoyin-Aje L, Beaver, MD JA, Pazdur R. Promoting Inclusion of Members of Racial and Ethnic Minority Groups in Cancer Drug Development. JAMA Oncol. Published online July 15, 2021. doi: 10.1001/jamaoncol.2021.2137
- Carpten, J.D., Fashoyin-Aje, L., Garraway, L.A. et al. Making cancer research more inclusive. Nat Rev Cancer (2021). 29 June 2021 doi: 10.1038/s41568-021-00369-7
- Gormley N, Fashoyin-Aje L, Locke T, Unger JM, Little RF, Nooka A, Mezzi K, Popa-McKiver M, Kobos R, Biru Y, Williams TH, and Anderson KC. Recommendations on Eliminating Racial Disparities in Multiple Myeloma Therapies: A Step toward Achieving Equity in Healthcare. Blood Cancer Discov March 1 2021 (2) (2) 119-124; DOI: 10.1158/2643-3230.BCD-20-0123
- The ASCO Post, September 25, 2020: Efforts to Broaden Eligibility Criteria for Clinical Trials Seek to Include More Racial and Ethnic Minority Patients, A Conversation with Lola A. Fashoyin-Aje, MD, MPH