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Featured Initiative: Advancing Inclusive Research® Site Alliance

Working Toward Equitable Clinical Trial Enrollment

I think it's so important to have good inclusive participation in all kinds of clinical trials…minority populations have been underrepresented for the longest time.

Illustration of a man.

—Amelie G. Ramirez, DrPH, AIR Site Champion, Chair and Professor of the Department of Population Health Sciences, Director of the Institute for Health Promotion Research, Director of the Salud America! program, Associate Director of Cancer Outreach and Engagement at the Mays Cancer Center

We must engage differently with underserved patient communities if we want to ensure the most representative and effective clinical research and achieve optimal treatment outcomes for all.

Illustration of a man.

—Quita Highsmith, Vice President and Chief Diversity Officer, Genentech

Problem

  • Only about 5% to 15% of US clinical trial participants are Black or Latino, yet non-white people are predicted to make up the majority of the US population by the year 20451-4
  • Clinical trials for cancer therapies may not be accessible to patients with diverse backgrounds, or people may mistrust the medical system1,2
  • Consequently, data suggests that Black and Latino people with serious diseases don’t have equal access to potentially life-saving investigational medicines5
  • Additionally, the data that should be collected across the entire spectrum of the US population aren’t available to clinicians, severely limiting the utility of those data and perpetuating healthcare disparities2,3

An example of how we’re addressing the problem

In June 2021, Genentech announced the launch of the Advancing Inclusive Research® (AIR) site alliance, a first-of-its-kind coalition of clinical research sites working together to:

  • Advance the representation of diverse patient populations in the company’s oncology clinical trials, test recruitment, and retention approaches
  • Establish best practices that can be leveraged across the industry to help achieve health equity for people with cancer

The AIR site alliance began with 4 US clinical research institutions that had a track record of recruitment and retention of underrepresented patient populations to enable equitable access to diagnosis, treatments, and clinical research studies.

Hispanics represent 60% of San Antonio’s population, and in areas of South Texas, 90% of our population. It is imperative that we advance treatment, learning how new cancer therapies may help the Latinos of South Texas… Our participation in this alliance will enable us to increase the number of Hispanics in clinical trials and develop information to improve the recruitment efforts of centers nationwide.

Illustration of a man.

—Ruben Mesa, MD, FACP, prior executive director of the AIR site alliance member Mays Cancer Center, UT Health San Antonio MD Anderson and current External Council for AIR member

By the numbers

Starting with 4 inaugural sites in 2021, the AIR site alliance currently encompasses 6 institutions in Oncology across 7 states in the United States

The proportion of diverse patients at AIR site alliance Oncology sites is 76% greater than at equivalent sites6-8

AIR site alliance sites have recruited 15% of all Black and Latino patients participating in our studies6,8

Educating Patients

To help patients better understand clinical research, Genentech, in collaboration with the Advancing Inclusive Research Site Alliance, has created animated videos in both English and Spanish that provide:

  • easy-to-understand information on the clinical research study process for patients with emphasis on representation and inclusion.
  • information to help patients make informed decisions about whether they should consider a clinical research study.

How might we strive to make health equity a reality for patients?

    • Coakley M, Fadiran EO, Parrish LJ, Griffith RA, Weiss E, Carter C. Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. J Womens Health (Larchmt). 2012;21(7):713-716. doi:10.1089/jwh.2012.37332

      Coakley M, Fadiran EO, Parrish LJ, Griffith RA, Weiss E, Carter C. Dialogues on diversifying clinical trials: successful strategies for engaging women and minorities in clinical trials. J Womens Health (Larchmt). 2012;21(7):713-716. doi:10.1089/jwh.2012.37332

    • Ma MA, Gutierrez DE, Frausto JM, Al-Delaimy WK. Minority representation in clinical trials in the United States: trends over the past 25 years. Mayo Clin Proc. 2021;96(1):264-266. doi:10.1016/j.mayocp.2020.10.027

      Ma MA, Gutierrez DE, Frausto JM, Al-Delaimy WK. Minority representation in clinical trials in the United States: trends over the past 25 years. Mayo Clin Proc. 2021;96(1):264-266. doi:10.1016/j.mayocp.2020.10.027

    • Garrick O, Mesa R, Ferris A, et al. Advancing inclusive research: establishing collaborative strategies to improve diversity in clinical trials. Ethn Dis. 2022;32(1):61-68. doi:10.18865/ed.32.1.61

      Garrick O, Mesa R, Ferris A, et al. Advancing inclusive research: establishing collaborative strategies to improve diversity in clinical trials. Ethn Dis. 2022;32(1):61-68. doi:10.18865/ed.32.1.61

    • Vespa A, Medina L, Armstrong D. Demographic Turning Points for the United States: Population Projections for 2020 to 2060. United States Census Bureau. Report number P25-1144. February 2020. Accessed September 7, 2023. https://www.census.gov/library/publications/2020/demo/p25-1144.html

      Vespa A, Medina L, Armstrong D. Demographic Turning Points for the United States: Population Projections for 2020 to 2060. United States Census Bureau. Report number P25-1144. February 2020. Accessed September 7, 2023. https://www.census.gov/library/publications/2020/demo/p25-1144.html

    • Kelsey MD, Patrick-Lake B, Abdulai R, et al. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials. 2022;116:106740. doi: 10.1016/j.cct.2022.106740

      Kelsey MD, Patrick-Lake B, Abdulai R, et al. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials. 2022;116:106740. doi: 10.1016/j.cct.2022.106740

    • RGNE Data Capture Hub (ECD and CTMS); scope of assessment is n=69 (48 in Oncology, 21 in Ophthalmology) studies; all data reflects US performance only regardless of if a study is international; Data accurate as of July 28, 2023, rounded to nearest whole number

      RGNE Data Capture Hub (ECD and CTMS); scope of assessment is n=69 (48 in Oncology, 21 in Ophthalmology) studies; all data reflects US performance only regardless of if a study is international; Data accurate as of July 28, 2023, rounded to nearest whole number

    • Diverse patients = patients with any combination of Black or Hispanic identity / heritage (e.g., Black- Hispanic; White-Hispanic; Black non-Hispanic, etc.); Figure represents the difference in percentage of ‘diverse’ patients enrolled vs. percentage of ‘non-diverse’ patients; Asian, Native American and other race/ethnicities excluded from analysis; one patient is only counted once in this algorithm; multi-racial, non-Hispanic patients are excluded due to inability to determine ethnicity

      Diverse patients = patients with any combination of Black or Hispanic identity / heritage (e.g., Black- Hispanic; White-Hispanic; Black non-Hispanic, etc.); Figure represents the difference in percentage of ‘diverse’ patients enrolled vs. percentage of ‘non-diverse’ patients; Asian, Native American and other race/ethnicities excluded from analysis; one patient is only counted once in this algorithm; multi-racial, non-Hispanic patients are excluded due to inability to determine ethnicity

    • Amongst studies and US sites in the data set

      Amongst studies and US sites in the data set