ASCO, ACCC Address Clinical Trial Diversity With Joint Recommendation

To bolster diversity in clinical trial enrollment a joint statement from the American Society of Clinical Oncology (ASCO) and the Association of Community Cancer Centers (ACCC) provides recommendations for reaching broader communities.¹ The statement, which includes 6 recommendations, encompasses highlights several areas for improvement including trial design, outreach efforts, and the publication of data.

Increasing the racial and ethnic diversity in clinical trials is vital for understanding the intrinsic and extrinsic factors that may affect patient response to cancer treatments. However, participants in clinical trials tend to be younger, healthier, and Whiter than the typical patient with cancer.

Furthermore, only 2% to 8% of all adults with cancer participate in clinical trials, making it difficult to know how results apply to real-world populations. Although Black patients represent 15% of patients with cancer and Hispanic patients represent 13%, just 4% to 6% of trial participants are Black and between 3% and 6% are Hispanic.

Even those small numbers may overestimate participation among Black and Hispanic patients because less than 33% of clinical trials report data on race and ethnicity. The 6 recommendations reflect an effort by ASCO and ACCC to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation.

Recommendations for Improving EDI in Clinical Trials

• Clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate
• Trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations
• Trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups
• Anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI
• Research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce
• Research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI

Barriers to Participation

ASCO and ACCC have found that 1 of the primary barriers to enrollment is that clinicians often fail to suggest trials as a treatment option to all potentially eligible patients. The 2 organizations have launched a pilot project to test the feasibility and utility of a site self-assessment and implicit bias training program and plan to publish findings at a later date.

The other primary barriers involved patients, trials, and institutions. More than half of patients with cancer do not participate in trials because of a lack information, a lack of local access, and/or they cannot find a trial that matches their disease characteristics.

Even when trials are available, the direct medical costs and indirect costs involved make trial participation unfeasible. Racial and ethnic minority populations often have lower socioeconomic status relative to White populations, making them more sensitive to financial pressures. These patients also report distrust of research/medical communities as a result of real or perceived medical mistreatment, fear of possible adverse effects, and lack of awareness about the benefits of trials. They often experience language, communication, and health literacy–related barriers.

Trial design can present barriers to participation. Eligibility criteria often exclude those racial and ethnic minority populations that are more likely to be sicker, have lower performance or functional status, and/or have pre-existing health conditions and trials often exclude patients with these characteristics. Trials that require numerous trial visits and/or frequent laboratory tests and biopsies may also pose barriers to participation.

Institutions determine what types of trials to open and where trials are conducted and establish the availability and diversity of research and support staff, all of which can affect the demographics of the trial population. Study data has shown that, when trial sites match the local population and are located at sites that serve people from racial and ethnic minority populations, trials become more diverse.

Although improvements in EDI have been slow, the oncology community has started putting money behind its initiatives. In June 2022, Janssen Pharmaceutical Companies of Johnson & Johnson donated $5 million to efforts by Stand Up To Cancer (SU2C) to increase diversity in phase 1 and 2 cancer clinical trials. Four groups of researchers will use the money to develop new approaches to remove barriers to clinical trial participation for patients of all racial and ethnic backgrounds, as well as patients in medically underserved communities.²

That same month, Novartis and the Novartis US Foundation committed $17.7 million to support Clinical Trial Centers of Excellence at the Howard University College of Medicine, Meharry Medical College and Charles R. Drew University of Medicine and Science as part of Beacon of Hope, the company’s 10-year collaboration with 26 Historically Black Colleges, Universities (HBCUs) and Medical Schools.³

In April 2022, the FDA issued a new draft guidance outlining plans for increased diversity in clinical trials. The agency noted that clinical trial enrollment should reflect the diversity in the population that will ultimately use the product.⁴

“The US population has become increasingly diverse and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” FDA Commissioner Robert M. Califf, MD, said in a news release. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities. This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics and clinical trials.”

References

1. 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;40(19):2163-2171. doi:10.1200/JCO.22.00754
2. Stand Up To Cancer announces $5 million sponsorship from Janssen in support of initiative to improve health equity in clinical trials. Stand Up To Cancer. News release. June 16, 2022. Accessed July 12, 2022. https://prn.to/3uHiWJ5
3. Novartis expands Beacon of Hope through alliances with Historically Black Medical Schools to address systemic health disparities. Novartis. News release. June 22, 2022. Accessed July 12, 2022. https://prn.to/3z2ksbr
4. FDA takes important steps to increase racial and ethnic diversity in clinical trials. US Food and Drug Administration. News release. April 13, 2022. Accessed July 12, 2022. https://bit.ly/3Phw9A6