Project Equity
Generating Evidence for Diverse Populations in Oncology
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, Office of Oncologic Diseases
Contact: OCE-Equity@fda.hhs.gov
- Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials
- 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
Events
- May 4, 2022: Cancer Moonshot: Community Conversations – Moving on Equity: OCE Expands Diversity Initiative. Meeting Information
- May 26-27, 2021: FDA Science Forum, Addressing the needs of underrepresented demographic subgroups in oncology
- March 9, 2021: Reagan-Udall Foundation for the FDA hosted roundtable: Generating Evidence for Racial and Ethnic Minorities During Development of Oncologic Therapeutics
- November 18 & 20, 2020: two-part FDA/OCE Symposium: Understanding Barriers to Oncology Clinical Trial Participation for Sexual and Gender Minorities
- September 29, 2020: NHC Annual Symposium on the Science of Patient Engagement, FDA Oncology Center of Excellence Initiatives to Advance Patient Engagement
- February 13, 2020: FDA-AACR Workshop to Examine Under-Representation of African Americans in Multiple Myeloma Clinical Trials
Publications
- Maignan K, Fashoyin-Aje LA, Torres AZ, et al. Exploring racial disparities in treatment patterns and outcomes for patients with multiple myeloma using real world data. Blood Cancer J. 2022 Apr 19;12(4):65.
- Kanapuru B, Fernandes LL, Fashoyin-Aje LA, et al. Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials. Blood Adv. 2022 Mar 22;6(6):1684-1691.
- Kizub D, Manner CK, Graef K, et al. Action for Increasing Diversity, Market Access, and Capacity in Oncology Registration Trials—Is Africa the Answer? Report From a Satellite Session of the Accelerating Anti-Cancer Agent Development and Validation Workshop. JCO Glob Oncol. 2022 Jun;8:e2200117.
- Alpert AB, Brewer JR, Adams S, et al. Addressing Barriers to Clinical Trial Participation for Transgender People With Cancer to Improve Access and Generate Data. J Clin Oncol. 2022 Oct 27:JCO2201174.
- Oyer RA, Hurley P, Boehmer L, et al. Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement. J Clin Oncol. 2022 Jul 1;40(19):2163-2171.
- Patel MI, Merrill JK, Smith K, et al. Assessing the needs of those who serve the underserved: A national survey among cancer care clinicians. J Clin Oncol. 2022 40:28_suppl, 175-175.
- Regnante JM, Fashoyin-Aje L, Sonet EM, et al. Abstract PO-084: The pharmaceutical industry in action: 2021 clinical research diversity and inclusion survey. Cancer Epidemiol Biomarkers Prev 1 January 2022; 31(1_Supplement), PO-084.
- Sridhara R, Marchenko O, Jang Q, et al. Letter to Editor. Evaluation of Treatment Effect in Underrepresented Populations in Cancer Trials: Discussion with International RegulatorsExternal Link Disclaimer. Statistics in Biopharmaceutical Research 2022 Oct 31.
- Fashoyin-Aje L, Beaver JA, Pazdur R. Promoting Inclusion of Members of Racial and Ethnic Minority Groups in Cancer Drug Development. JAMA Oncol. 2021 Oct 1;7(10):1445-1446.
- Carpten JD, Fashoyin-Aje L, Garraway LA, et al. Making cancer research more inclusive. Nat Rev Cancer (2021). 29 June 2021.
- Gormley N, Fashoyin-Aje L, Locke T, et al. Recommendations on Eliminating Racial Disparities in Multiple Myeloma Therapies: A Step toward Achieving Equity in Healthcare. Blood Cancer Discov March 1 2021; 119-124.
- 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