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                Oncology Center of Excellence

Oncology Center of Excellence

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          Project EquityOncology Center of Excellence Project Equity
  
  					Generating Evidence for Diverse Populations in Oncology
	
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              Project Equity 2023**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

Diversity Plans in Oncology: Year One Experience
	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.

**Voluntary Submission of Diversity Plans to Oncology Review Divisions Year One Experience: April 2022 - April 2023** (PDF)

Diversity in Oncology Drug Development and New Legislation
	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.

**Clinical Trial Diversity: Oncology Perspective and New FDA Policies**(PDF)

FDA Guidance Documents
	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
	Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
	Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
	Inclusion of Older Adults in Cancer Clinical Trials
	Evaluation of Sex-Specific Data in Medical Device Clinical Studies
	Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs

News, Events and Publications
	**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 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

                                                                                  Content current as of:
      12/06/2023Oncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
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                        OCE Annual Reports
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