The American Society of Clinical Oncology (ASCO) and the Association of Community Cancer Centers (ACCC) today jointly released recommendations that address the lack of equity, diversity, and inclusion (EDI) in cancer clinical trials. Published in the Journal of Clinical Oncology, “Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement” details specific actions to engage the entire cancer clinical trial ecosystem in expanding the participation of underrepresented individuals in research that advances progress against cancer.
“Ensuring that every individual with cancer has an opportunity to participate in high-quality, equitable cancer research, will take a concentrated effort by all stakeholders,” said ASCO Board Chair Lori J. Pierce, MD, FASTRO, FASCO, who is co-chair of the ASCO-ACCC Steering Group. “Removing barriers to enrollment and participation for people historically underrepresented in clinical trials is a critical scientific and ethical imperative for the entire cancer community.”
The ASCO-ACCC research statement underscores that inclusive participation in clinical trials is necessary to understand potential differences in efficacy and safety across diverse populations, mitigate racial and ethnic disparities in health outcomes, and promote equity and justice. Progress to address barriers and increase diversity, however, remains elusive and change has been slow. Despite representing 15% and 13% of people with cancer in the U.S., respectively, only 4%-6% of trial participants are Black and 3%-6% are Hispanic.1,2,3
“In releasing these recommendations, we acknowledge that a concerted commitment by all research stakeholders is critically necessary to increase equity, diversity, and inclusion, and address barriers to cancer clinical trial recruitment and participation,” said ACCC Past President Randall A. Oyer, MD, and co-chair of the ASCO-ACCC Steering Group. “Our joint research statement offers a useful and holistic guide for addressing barriers at the clinician, patient, trial, and research program levels. While ASCO and ACCC will continue to work to advance the recommendations in this publication, we believe everyone involved in cancer research will be able to see how they may individually and collectively contribute to this critical endeavor.”
The recommendations, summarized in this illustration, focus on key areas that address barriers to cancer clinical trials including:
- Access to clinical trials: Clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate.
- Equity focused design: Clinical trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI and work with sites to conduct clinical trials in ways that increase participation of underrepresented populations.
- Partnerships among stakeholder groups: Clinical trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups.
- Continuous education and training: Anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication to build trust, and a commitment to achieving equity, diversity, and inclusion in clinical trials.
- EDI investment: Research stakeholders should invest in programs and policies that increase EDI in clinical trials and in the research workforce.
- Sharing data and strategies: Research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting the results of trials, programs, and interventions used to increase EDI.
The full ASCO-ACCC Research Statement clarifies which clinical trial stakeholders would be instrumental in implementing specific recommendations, while encouraging all research stakeholders to help achieve the ultimate goal of ensuring cancer clinical trials reflect the racial and ethnic diversity of people with cancer.
The recommendations draw from an extensive literature review and consensus discussion by the ASCO-ACCC Steering Group—comprised of EDI experts and stakeholders—and the Patient Partners Advisory Group of cancer research advocates and patients representing racial and ethnic minority populations.
The publication of the ASCO-ACCC Research Statement is an important milestone of the ASCO and ACCC collaboration. The ASCO-ACCC joint initiative launched in July 2020 with a request for ideas (RFI) that sought novel strategies and practical solutions to increase participation of underrepresented racial and ethnic populations in cancer treatment trials. Based on the responses, the Steering Group then developed and pilot tested a Research Site Self-Assessment and an Implicit Bias Training Program with 75 research sites across the United States. With the pilot testing now completed, the Assessment and Training will be available for free public access in the summer of 2022. These resources will help the cancer research community advance the Research Statement’s recommendations.
1 Unger JM, Vaidya R, Hershman DL, et al: Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. J Natl Cancer Inst 111:245-255, 2019
2 Duma N, Aguilera JV, Paludo J, et al: Representation of minorities and women in oncology clinical trials: Review of the past 14 years. JCO Oncol Pract 14: e1-e10, 2018
3 Murthy VH, Krumholz HM, Gross CP: Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 291:2720-2726, 2004