Addressing the Lack of Diversity in Cancer Clinical Trials

Although studies have demonstrated an overall reduction in cancer mortality in recent years, findings have revealed disparities in survival between various racial and ethnic groups.¹ In an update on cancer trends published in 2017 by the American Cancer Society and other public health organizations, the adjusted relative risk of cancer death was 33% higher (hazard ratio [HR], 1.33; 95% CI, 1.32-1.34) in non-Hispanic Black patients and 51% higher (HR, 1.51; 95% CI, 1.46-1.56) in non-Hispanic American Indian/Alaska Native patients compared to non-Hispanic White patients from 2006 to 2012.²  

Such disparities ultimately “stem from hundreds of years of structural racism, including residential, educational, occupational segregation, and discriminatory policies in criminal justice and housing, which have altered the balance of prosperity, security, and health” and led to differences in exposure to cancer risk factors and access to health care, wrote Birhiray and Birhiray in an article published in August 2022.¹

Several other recent papers also pointed to the lack of diversity in cancer trials as a key factor influencing disparities and inequities in cancer care and cancer outcomes. “It is clear that currently all the major interventions in prevention and therapeutic advances occur through testing in clinical trials,” and non-White minorities are significantly underrepresented in cancer research, wrote Wafik S. El-Deiry, MD, PhD, FACP, American Cancer Society research professor, and colleagues in a 2021 published opinion.³

Although these groups represent roughly 40% of the US population and experience worse health outcomes than White patients, they comprised only 25% of participants in trials investigating the 53 medications that were granted approval from the US Food and Drug Administration in 2020.⁴ 

Factors Driving Underrepresentation 

Among the many factors driving the dearth of diversity in cancer trials, “There are obvious factors such as medical mistrust, which is further fueled by the lack of representation in the medical community,” said Ashani T. Weeraratna, PhD, the E.V. McCollum Professor and chair of biochemistry and molecular biology at the Johns Hopkins Bloomberg School of Public Health, a Bloomberg Distinguished Professor,  and professor of oncology at the Johns Hopkins University School of Medicine in Baltimore, Maryland [email interview; September 2022]. “Too many patients are asked to trust doctors who do not look like them and may not understand them.”

Dr Weeraratna and colleagues discussed such challenges in a 2020 paper.⁵ She notes a lack of community outreach aimed at addressing these issues and language barriers that especially affect the Latinx community. Lack of access represents an additional barrier to trial participation, including transportation challenges and the cost of parking at hospitals, for example.  

Many patients are never even screened for eligibility, as “staff often think it takes too long to explain the trial to nonmainstream patients,” added Electra D. Paskett, PhD, the Marion N. Rowley Professor of Cancer Research and director in the division of cancer prevention and control, professor in the division of epidemiology, and founding director of the Center for Cancer Health Equity at The Ohio State University in Columbus [email interview; September 2022]. She coauthored a commentary on the topic.⁶ “I would also say that we don’t design trials with questions specific to minority patients, nor do we design trials with intent to see if the intervention works in all patients — which requires accruing enough participants from different groups to be able to assess effects in each population,” Dr Paskett stated.

Overcoming Barriers

Reducing barriers to cancer trial participation will involve “more community outreach and educational activities, interacting with the community to build trust and understand cultural or other barriers, implementing action plans to reach different racial and ethnic groups and the underserved, and solving logistical issues such as transporting,” according to Dr El-Deiry, who is also the associate dean for oncologic sciences at the Warren Alpert Medical School and director of the Legorreta Cancer Center at Brown University in Providence, Rhode Island [email communication; September 2022].

Addressing the issues that impede trial participation may include paying for lunch, parking, rideshare services, and other out of pocket expense, as well as increasing recruitment of underrepresented minority (URM) physicians and nurses, Dr Weeraratna explained. 

Additionally, providers “need to assess eligibility of all patients and address where there are holes in research portfolios, and they should educate staff and offer resources to assist patients, such as CT navigators and interpreters,” Dr Paskett advised. “We also need to think about rethinking how we design our trials” to make them more inclusive. 

Clinician Advocacy

To advocate for greater diversity in cancer trials, Dr El-Deiry encourages clinicians to increase their awareness of the cultural, language, and financial barriers that limit participation among different racial and ethnic groups, Dr El-Deiry said. “Clinicians should ask themselves, ‘What can I do and how can I help with these issues?’” Key suggestions include making efforts to better connect with patients and families to build trust and working with local cancer centers to get involved in community outreach activities that are focused on these issues. “Clinicians can also get involved in efforts to reduce disparities in health care either through advocacy, through their professional associations, or through their institutions.”

Dr Weeraratna emphasizes the importance of increased representation of racial and ethnic minorities in medicine and advises clinicians to support the recruitment and retention of URM physicians and nurses and to continue this support once these professionals enter the health care system. “I hear often from women physicians — especially those of color — that they struggle to be taken seriously by patients, their superiors, and even the nursing staff, despite the fact they often have closer relationships with them than their male colleagues do,” she shared. 

These recommended measures align with those of the DRIVE initiative developed by the non-profit Indy Hematology Education Inc and described by Birhiray and Birhiray.¹ Based on relevant research findings and professional guidelines, DRIVE consists of 5 practical strategies to promote diversity, equity, and inclusion in cancer research:

Diversity officer for clinical research studies 

Ranking of clinical studies for diversity 

Individual diversity, equity, inclusion, and access plan 

Verification of study diversity 

Elevate and enhanced training of minority investigators and research team members

Achieving progress in the push toward greater diversity in cancer trials will require deliberate actions like those comprising DRIVE, according to the authors.¹ Such steps are essential to improving outcomes across racial and ethnic groups. 

“Rectifying the disparity in the representation of patients in clinical trials is critical to improve outcomes for all patients and to identify the right treatments for each patient,” Dr Weeraratna stated. 

References

1. Birhiray MN, Birhiray RE. Practical strategies for creating diversity, equity, inclusion, and access in cancer clinical research: DRIVE [Letter]. Published online August 25, 2022. Blood Adv. doi:10.1182/bloodadvances.2022008220
2. Jemal A, Ward EM, Johnson CJ, et al. Annual report to the nation on the status of cancer, 1975-2014, featuring survival. J Natl Cancer Inst. 2017;109(9):djx030. doi:10.1093/jnci/djx030
3. El-Deiry WS, Giaccone G. Challenges in diversity, equity, and inclusion in research and clinical oncology [Opinion]. Front Oncol. 2021;11:642112. doi:10.3389/fonc.2021.642112
4. Gray DM 2nd, Nolan TS, Gregory J, Joseph JJ. Diversity in clinical trials: an opportunity and imperative for community engagement. Lancet Gastroenterol Hepatol. 2021;6(8):605-607. doi:10.1016/S2468-1253(21)00228-4
5. Brady DC, Weeraratna AT. The race toward equity: increasing racial diversity in cancer research and cancer care. Cancer Discov. 2020;10(10):1451-1454. doi:10.1158/2159-8290.CD-20-1193
6. Kahn JM, Gray DM 2nd, Oliveri JM, Washington CM, DeGraffinreid CR, Paskett ED. Strategies to improve diversity, equity, and inclusion in clinical trials. Cancer. 2022;128(2):216-221. doi:10.1002/cncr.33905