The OCE Equity Program
Generating Evidence for Diverse Populations in Oncology
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The OCE Equity Program is a public health initiative established by the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) to improve access to clinical trials of oncology medical products for populations that have been historically 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. The OCE Equity Program seeks to advance equitable access to clinical trials for all patients with cancer through policy, research, and education.
Goals of The OCE Equity Program:
- 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.
OCE looks forward to further engaging with the community and other stakeholders to advance this effort. For inquiries regarding this program, please contact OCE-Equity@fda.hhs.gov.
Program Leads: Nicole Gormley, MD, Associate Director for Equity Advancement, OCE; and Tamy Kim, PharmD, Director for Regulatory Affairs and Policy, OCE
Program Manager: Jennifer Lee, PharmD, RAC; Senior Health Scientist, OCE
In April 2022, FDA issued a draft guidance recommending that sponsors of certain drugs, biological products, and devices (medical products), submit Diversity Plans (DPs) that describe their plan to enroll racially and ethnically representative populations in clinical trials intended to support the approval or licensing of these medical products.
In the following report, Project Equity analyzes Diversity Plan submissions in the CDER oncology divisions during the first year following publication of the draft guidance.
This slide deck describes clinical trial diversity from the Oncology Center of Excellence (OCE) perspective, describes OCE Project Equity, provides an overview of FDA's guidance on Diversity Plans, and describes new legislation relevant to clinical trial diversity.
- Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies - draft guidance, 2024.
- Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products - final guidance, 2023.
- Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials - draft guidance, 2022.
- Inclusion of Older Adults in Cancer Clinical Trials - final guidance, 2022.
- Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs - final guidance, 2020.
- Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections - final guidance, 2020.
- Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies - final guidance, 2020.
- Cancer Clinical Trial Eligibility Criteria: Brain Metastases - final guidance, 2020.
- Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials - final guidance, 2019.
- Collection of Race and Ethnicity Data in Clinical Trials - final guidance, 2016.
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies - final guidance, 2014.
- Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs - final guidance, 1993.
Videos
- The Cancer Letter: FDA’s Lola Fashoyin-Aje: It's time to fix disparities in access to clinical trials (2021 Nov 12).
- 2021 Cholangiocarcinoma Annual Conference: Balancing Efficiency and Inclusivity to Develop Therapeutics that Work for All (2021 Apr 15)
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
- Kanapuru B, Fernandes L, Baines A, Ershler R, Bhatnagar V, Pulte E, Gwise T, Theoret M, Pazdur R, Fashoyin-Aje L, Gormley N. Eligibility criteria and Enrollment of a Diverse Racial and Ethnic population in Multiple Myeloma Clinical Trials. Blood. 2023 Jul 20.
- Fashoyin-Aje LA, Tendler C, Lavery B, Ghiorghiu S, Gerald B, Kalidas C, Richie N, Winson K, Warren NJH, Tellman TV, Retzlaff J, Foti M, Pazdur R; Driving Diversity and Inclusion in Cancer Drug Development – Industry and Regulatory Perspectives, Current Practices, Opportunities, and Challenges. Clin Cancer Res. 2023 Jun 28.
- Patel M, Hinyard L, Hlubocky F, Merrill J, Smith K, Kamaraju S, Carrizosa D, Kalwar T, Fashoyin-Aje L, Gomez S, Jeames S, Duma N, Kircher S, Tap W. Assessing the Needs of Those Who Serve the Underserved: A Qualitative Study among US Oncology Clinicians. Cancers. 2023 Jun 23.
- Yang F, Huang Y, Lerro C, Liu W, Fiero M, Feng Z, Kanapuru B, Patel T, Amiri-Kordestani L, Ison G, Fashoyin-Aje L, Kluetz P, Singh H, Rivera D. Enrollment representation of age, race, and ethnicity in ovarian cancer registrational clinical trials (2010-2020): An evaluation by the U.S. Food and Drug Administration. Jour Clin Oncol. 2023 Jun 1.
- Pulte D, Fernandes L, Wei V, Woods A, Norsworthy K, Gormley N, Kanapuru B, Gwise T, Pazdur R, Schneider J, Theoret M, Fashoyin-Aje L, De Claro, RA. FDA Analysis of Ineligibility for Acute Myeloid Leukemia Clinical Trials by Race and Ethnicity. Clinical Lymphoma Myeloma and Leukemia. 2023 Jun.
- Acuña-Villaorduña A, Celebre Baranda J, Boehmer J, Fashoyin-Aje L, Gore SD. Equitable Access to Clinical Trials: How Do We Achieve It? ASCO Educational Book. 2023 May 5. Volume 43.
- Guerra C, Pressman A, Hurley P, Garrett-Mayer E, Bruinooge S, Howson A, Kaltenbaugh M, Williams J, Boehmer L, Bernick L, Byatt L, Charlot M, Crews J, Fashoyin-Aje L, McCaskill-Stevens W, Merrill J, Nowakowski G, Patel M, Ramirez A, Pierce L. Increasing Racial and Ethnic Equity, Diversity, and Inclusion in Cancer Treatment Trials: Evaluation of an ASCO-Association of Community Cancer Centers Site Self-Assessment. JCO-Oncol Practice. 2023 Apr 1.
- Fashoyin-Aje L, et al. Generating evidence for racial and ethnic minorities during development of oncologic therapeutics. RF Quarterly. 2023;3(1)23-30. Published online 22 March 2023.
- Biel T, Petrovskaya S, Mascia F, Ju T, Fashoyin-Aje L, Herremans K, Riner A, Underwood P, Gerber M, Donoghue M, Trevino J, Rao A. Transcriptomic analysis of pancreatic adenocarcinoma specimens obtained from Black and White patients. PloS one. 2023 Feb 22.
- Solarte M, Sacristan B, Boehmer L, Fashoyin-Aje L, Hobbs K. Abstract A014: An analysis comparing the geographic distribution of community cancer center providers to CRC prevalence rates among Medicare beneficiaries. Cancer Epidemiology, Biomarkers & Prevention. 2023 Jan 1, A014-A014.
- Sridhara R, Marchenko O, Jang Q, et al. Letter to Editor. Evaluation of Treatment Effect in Underrepresented Populations in Cancer Trials: Discussion with International Regulators. Statistics in Biopharmaceutical Research 2022 Oct 31.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. 2021 March 1; 119-124.
- The ASCO Post, Sept. 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
Additional Resources
- OCE Project ASIATICA
- OCE Project Silver
- OCE Community Engagement: Project Community
- OCE Education Program: Project Socrates
- OCE Summer Scholars Program
- FDA Drug Trials Snapshots
- FDA Minority Health and Health Equity Research and Collaboration
- Enhancing the Diversity of Clinical Trial Populations – Guidance Snapshot for Industry and Guidance Recap Podcast for Industry
- Enhancing the Diversity of Clinical Trial Populations – Guidance Snapshot for Patients and Guidance Recap Podcast for Patients