Diversify Your Cancer Clinical Trials With New Recruitment and Retention Resources

Lori J. Pierce, MD, FASTRO, FASCO

The American Society of Clinical Oncology (ASCO) and the Association of Community Cancer Centers (ACCC) today jointly released two resources to help research sites increase the racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials.

The Just ASK^™ Increasing Diversity in Cancer Clinical Research: An ACCC-ASCO Training Program (Just ASK^™ Training Program), and the ASCO-ACCC Equity, Diversity, and Inclusion Research Site Self-Assessment (Site Self-Assessment) are available free-of-charge online. This release follows a successful pilot project with 75 research sites across the United States, which assessed the feasibility and utility of the resources.

“Increasing equity, diversity, and inclusion in cancer clinical trials is foundational to conducting medical research that can be generalized to and benefit all patients with cancer,” said Association for Clinical Oncology Board Chair Lori J. Pierce, MD, FASTRO, FASCO, who is co-chair of the ASCO-ACCC Steering Group. “From the outset of this initiative, our goal was to develop practical resources that research sites could readily use to foster meaningful change. Our pilot project demonstrated the value of the training and site self-assessment, and we are delighted that we can now offer them to the broader cancer research community.”

The availability of the Just ASK™ Training Program and Site Self-Assessment follows the recent publication of the ASCO-ACCC Research Statement “Increasing Racial and Ethnic Diversity in Cancer Clinical Trials,” which outlines specific actions for individual stakeholders in the cancer clinical trial ecosystem to increase diversity in research participation. The new resources directly address some of the recommendations in the Research Statement.

“With the release of the Training Program, Site Self-Assessment, and Research Statement, research sites can now have a set of cohesive tools to help take concrete, tangible steps that will have a real impact in addressing what has been an intractable problem—the lack of diversity in cancer clinical trials,” said ACCC Past President Randall A. Oyer, MD, and co-chair of the ASCO-ACCC Steering Group. “Sites can take advantage of the Training Program to support individual members of their research teams, and the Site Self-Assessment to examine and address screening and enrollment barriers at a systemic level. We believe that, by operating at both the individual and system levels, the research community can really begin to move the needle and increase diversity in cancer trials.”

Just ASK^™ Training Program to Address Implicit Bias

Studies have found that implicit bias reduces the likelihood of clinicians offering clinical trials to racially and ethnically marginalized patients compared to patients who are White.1-5 However, when trial participation is offered, more than half (55%) of patients agreed to enroll regardless of race and ethnicity.6&

The Just ASK™ Training Program, adapted from a course developed at Duke University, is an online implicit bias training program intended for all members of the research team. It consists of five interactive modules—which can be completed independently in about in 60-90 minutes—that present the broader context of structural and systemic racism, the role of implicit bias in clinical trial selection, vignettes with real-world examples of implicit bias, and guidance for mitigating disparities in cancer research settings. A companion Facilitation Guide is also available to help sites continue the conversation with the larger research team after taking the training.

ASCO-ACCC EDI Research Site Self-Assessment

The Site Self-Assessment helps clinical trial sites and research teams identify opportunities to improve EDI in clinical trials while doing an internal review of existing policies, programs, and procedures that offer evidence-based strategies to improve the diversity of trial participants. The Site Self-Assessment is a quality improvement tool framed around the clinical trial enrollment continuum, and includes domains related to patient access to the site, screening patients for clinical trials, offering patients clinical trials, and participation and retention in trials. Completion of the Site Self-Assessment enables sites to identify opportunities for improvement. The ASCO-ACCC Strategies and Resources List for EDI in Clinical Trials also provides suggestions for evidence-based strategies to address these opportunities and references to the literature. Potential strategies include diversifying the workforce, developing sustainable community partnerships, implicit bias training, and routinely collecting screening and enrollment data to assess and address disparities.

The Training Program and Site Self-Assessment resources were revised based on site feedback during the pilot testing period. The findings from the pilot study have been submitted for publication. ASCO and ACCC are pleased to make these resources available free of charge to the entire research community. ASCO and ACCC are eager to receive feedback from the community and plan to continue to enhance and expand the resources.

The development and release of these resources is an important milestone in the ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials. The initiative is led by a steering group of EDI experts, patient advocates, and other stakeholders. ASCO and ACCC formed a Patient Partners Advisory Group, which also informs the work of the collaboration, and includes cancer research advocates who represent racial and ethnic minority populations. The steering group sought to answer the call from the oncology community for tangible resources to help improve representation in cancer clinical trials – as evidenced by the eager involvement of 75 research sites in the pilot study. With the Research Site Self-Assessment, Training Program, Facilitation Guide, and Research Statement recommendations, it is ASCO and ACCC’s hope that sites feel supported and empowered to make change.

Access these resources and learn more about the ASCO-ACCC Collaboration and all of ASCO’s health equity initiatives at asco.org/equity. Visit accc-cancer.org/equity for resources and education from ACCC.

References

1. Niranjan SJ, Martin MY, Fouad MN, et al. Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials. Cancer 2020; 126(9): 1958-68.
2. Howerton MW, Gibbons MC, Baffi CR, et al. Provider roles in the recruitment of underrepresented populations to cancer clinical trials. Cancer 2007; 109(3): 465-76.
3. Moskowitz GB, Stone J, Childs A. Implicit stereotyping and medical decisions: unconscious stereotype activation in practitioners' thoughts about African Americans. Am J Public Health. 2012; 102(5): 996-1001.
4. Hamel LM, Penner LA, Albrecht TL, Heath E, Gwede CK, Eggly S. Barriers to Clinical Trial Enrollment in Racial and Ethnic Minority Patients With Cancer. Cancer Control. 2016; 23(4): 327-37.
5. Maina IW, Belton TD, Ginzberg S, Singh A, Johnson TJ. A decade of studying implicit racial/ethnic bias in healthcare providers using the implicit association test. Soc Sci Med 2018; 199: 219-29.
6. Unger J, Hershman D, Till C, Minasian L, Osarogiagbon R, Fleury M, Vaidya R. “When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials. Journal of the National Cancer Institute. 2020; djaa155. https://academic.oup.com/jnci/article/113/3/244/5918345