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

Abstract

Patients of African ancestry are not well-represented in cancer clinical trials despite bearing a disproportionate share of mortality both in United States and Africa. We describe key stakeholder perspectives and priorities related to bringing early-stage cancer clinical trials to Africa and outline essential action steps. Increasing Diversity, Market Access, and Capacity in Oncology Registration Trials—Is Africa the Answer? satellite session was organized at 2021 Accelerating Anti-Cancer Agent Development and Validation Workshop. Panelists included representatives of African Organization for Research and Training in Cancer, Uganda Cancer Institute, Uganda Women's Cancer Support Organization, BIO Ventures for Global Health, Bill & Melinda Gates Foundation, the US Food and Drug Administration, Nigeria's National Agency for Food and Drug Administration and Control, Bayer, and Genentech, with moderators from ASCO and American Cancer Society. Key discussion themes and resulting action steps were agreed upon by all participants. Panelists agreed that increasing diversity in cancer clinical trials by including African patients is key to ensuring novel drugs are safe and effective across populations. They underscored the importance of equity in clinical trial access for patients in Africa. Panelists discussed their values related to access and barriers to opening clinical trials in Africa and described innovative solutions from their work aimed at overcoming these obstacles. Multisectoral collaboration efforts that allow leveraging of limited resources and result in sustainable capacity building and mutually beneficial long-term partnerships were discussed as key to outlined action steps. The panel discussion resulted in valuable insights about key stakeholder values and priorities related to bringing early-stage clinical trials to Africa, as well as specific actions for each stakeholder group.

Equitable inclusion of diverse populations in oncology clinical trials: deterrents and drivers

“… 8 Indigenous communities, such as American Indian/Alaska Native populations, have the lowest representation within the racial and ethnic spectrum in the United States. 25 Notably, global cancer clinical trials have limited representation in some regions, such as Africa 26 and Latin America. 27 These observations are disturbing, given distinct genetic and health disparities impacting treatment responses, particularly among African patients.…”

Exploring new frontiers in prostate cancer research: Report from the 2022 Coffey−Holden prostate cancer academy meeting

“…13 However, most of these treatments are based on tumor characteristics and their vulnerabilities from studies in populations composed primarily of non-Hispanic European American men, which may not benefit underrepresented populations like African American (AA) patients. 15,16 Fortunately, new research deciphering the molecular profiles and tumor biology of AA prostate cancers suggests that AA patients may have a unique biological phenotype of prostate cancer and host immunity that could impact antitumor immune response or response to emerging targeted therapies. [17][18][19] More research into the factors that contribute to prostate cancer disparities, and a better understanding of barriers to health equity are major areas of needed research.…”

“…In recent years, we have begun to identify novel and dynamic molecular characteristics of prostate cancers that have revolutionized therapeutic approaches to achieve the best clinical outcome 13 . However, most of these treatments are based on tumor characteristics and their vulnerabilities from studies in populations composed primarily of non‐Hispanic European American men, which may not benefit underrepresented populations like African American (AA) patients 15,16 . Fortunately, new research deciphering the molecular profiles and tumor biology of AA prostate cancers suggests that AA patients may have a unique biological phenotype of prostate cancer and host immunity that could impact antitumor immune response or response to emerging targeted therapies 17–19 .…”

Global Equity in Clinical Trials: An ASCO Policy Statement

“…Lack of diversity in clinical trial results exacerbates longstanding inequities in clinical care. 12 Research predominantly conducted in HICs fails to account for the diverse genetic and environmental factors that influence cancer incidence, disease outcomes, and treatment response. Stakeholder policies on global equity vary, reflecting the complex nature of the problem.…”

“…There is a growing focus on global collaboration in clinical research. 12 Efforts are underway to conduct multinational oncology trials, enable secure data sharing for cancer genomics research, advance precision oncology, improve clinical trials for rare cancers, enhance coordination of cancer research, and support for pooling expertise and resources, to name a few (Table 1 ). Although these are encouraging, their consensus around how to close gaps in global cancer research has been elusive and there is a need for more concerted global efforts by stakeholders if we are to achieve progress in treatment and in health equity.…”