By Fumiko Chino, MD
ASTRO's Committee on Health Equity, Diversity and Inclusion (CHEDI) has made recruitment and inclusion of underrepresented minorities into cancer clinical trials a top priority for the upcoming year.
Clinical trials are the mainstay in the development and validation of new cancer therapies and treatment options. Despite the potential for access to novel new treatments and technologies, less than one in 20 adult patients with cancer participate in a clinical trial.1 This disparity is even starker for racial and ethnic minorities1 with data showing that the clinical trial enrollment of racial/ethnic minorities has actually decreased over the past 14 years.2 In 2012, only 17% of patients enrolled in industry-sponsored clinical trials were of a racial or ethnic minority, despite these groups making up about one-third of the population.3 One evaluation found that black participation reached 10% for only two of the 31 cancer drugs studied.4 Clinical trial participants are disproportionately non-Hispanic white men with higher education levels and household incomes.1,5
With skewed enrollment and participation, conclusions of clinical trials may be questioned for how generalizable they may be to patients not fully represented in the trial cohort.6 As racial/ethnic minorities carry some of the highest cancer burdens in the United States, equitable participation in clinical trials becomes an important tool in the fight against health care disparities. Adequate representation in cancer research is essential in the development of therapies that are both effective and tolerable to patients from diverse backgrounds. Recurring themes in the assessment of barriers to clinical trial enrollment for racial/ethnic minorities include trust, costs and access/knowledge:
- Trust in medical providers and the health care establishment is a known obstacle for minority engagement. From infamous historical outrages like the Tuskegee Syphilis Study and forced sterilization in segregated hospitals, distrust has been a valid protective measure for many patients for centuries. One study looking at barriers to cancer research found that almost one-third of the black women surveyed agreed that scientists “cannot be trusted” (compared to 4% of white women).7 Trust concerns can be exacerbated by the lack of minority investigators,8 making workforce diversity9,10 an essential target action to improve trust.
- Costs remain a consistent barrier to clinical trial participation, particularly among racial/ethnic minorities.12 Lower income patients are much less likely to participate across all subgroups5 and increased out-of-pocket costs were consistently stated as a concern limiting enrollment.13 Although the costs of study drugs, tests and procedures are typically covered under protocol, there are many “hidden costs” including gas, hotels and missed work.14 Extra costs are in part due to more frequent clinic visits and travel as most comprehensive cancer centers leading clinical trials are in major metropolitan centers. Although there are fears that financial incentives may create a type of economic pressure for patients with lower socioeconomic status to participate, the additive costs of participation are often exclusionary for those with fewer resources.
- Access/knowledge continues to limit many patients who may be otherwise willing and eligible for clinical trial participation. Black/African American patients are less likely to be aware of clinical trials17 and provider referral may also be limited. In one study of black women, almost all participants stated their doctor had “never talked to them” about participating in a clinical trial.18
- Workforce: In addition to improving diversity in physician workforce, which is a long-term process, greater community involvement and use of culturally concordant staff (for example, Hispanic staff and Spanish language-based education materials) have led to improved enrollment in certain target populations.11
- Cost: One intervention of graded financial assistance demonstrated the ability to improve clinical trial equity with successful increased enrollment for those patients typically underrepresented in trials.15 Expanding trials into community cancer centers may also decrease travel costs and increase participation.16
- Access/Knowledge: Targeting enrollment toward specific cultural background and literacy levels may improve recruitment of underrepresented populations.12 Patient navigation programs also hold unique promise to help recruit and retain racial and ethnic minority populations in clinical trials. One study found that black/African American enrollment increased from 9% to 16% after initiating an education and tailored support program.19
CHEDI has highlighted ways that equity, diversity and inclusion can be improved within radiation oncology since its creation as a committee. By focusing this year on underrepresented minority clinical trial enrollment, we hope to raise awareness of this crucial issue and ultimately increase access and outcomes for our patients. Share your suggestions for how to encourage minorities to enroll in clinical trials in the comments below.
Fumiko Chino is transitioning from chief resident in Radiation Oncology at Duke Cancer Institute and the Teaching Value in Health Care Learning Network Fellow for the Costs of Care, a global NGO. She will join the faculty at Memorial Sloan Kettering Cancer Center in August 2019.
- Murthy VH, Krumholz HM, Gross CP: Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 291:2720-6,2004.
- Duma N, Vera Aguilera J, Paludo J, et al: Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years. J Oncol Pract. 14:e1-e10,2018.
- Proportion of Study Volunteers by Race and Ethnicity in Clinical Research Studies, 2012. JNCI: Journal of the National Cancer Institute. 109, 2017.
- Propublica. "Black Patients Miss Out On Promising Cancer Drugs" Published September 19, 2018, accessed June 23, 2019 at https://www.propublica.org/article/black-patients-miss-out-on-promising-cancer-drugs.
- Unger JM, Gralow JR, Albain KS, et al: Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study. JAMA Oncol. 2:137-9, 2016.
- Rothwell PM: External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 365:82-93, 2005.
- Mouton CP, Harris S, Rovi S, et al: Barriers to black women's participation in cancer clinical trials. J Natl Med Assoc. 89:721-7, 1997.
- McCaskill-Stevens W, Pinto H, Marcus AC, et al: Recruiting minority cancer patients into cancer clinical trials: a pilot project involving the Eastern Cooperative Oncology Group and the National Medical Association. J Clin Oncol. 17:1029-39, 1999.
- Winkfield KM, Flowers CR, Patel JD, et al: American Society of Clinical Oncology Strategic Plan for Increasing Racial and Ethnic Diversity in the Oncology Workforce. J Clin Oncol. 35:2576-2579, 2017.
- Winkfield KM, Gabeau D: Why workforce diversity in oncology matters. Int J Radiat Oncol Biol Phys. 85:900-1, 2013.
- Symonds RP, Lord K, Mitchell AJ, et al: Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines. Br J Cancer. 107:1017-21, 2012.
- Ford JG, Howerton MW, Lai GY, et al: Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 112:228-42, 2008.
- Unger JM, Hershman DL, Albain KS, et al: Patient income level and cancer clinical trial participation. J Clin Oncol. 31:536-42, 2013.
- Chino F, Zafar SY: Financial Toxicity and Equitable Access to Clinical Trials. Am Soc Clin Oncol Educ Book. 39:11-18, 2019.
- Nipp RD, Lee H, Powell E, et al: Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program. Oncologist. 21:467-74, 2016.
- Copur MS, Ramaekers R, Gonen M, et al: Impact of the National Cancer Institute Community Cancer Centers Program on Clinical Trial and Related Activities at a Community Cancer Center in Rural Nebraska. J Oncol Pract. 12:67-8, e44-51, 2016.
- Lara PN, Jr., Paterniti DA, Chiechi C, et al: Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. J Clin Oncol. 23:9282-9, 2005.
- Trauth JM, Jernigan JC, Siminoff LA, et al: Factors affecting older African American women's decisions to join the PLCO Cancer Screening Trial. J Clin Oncol. 23:8730-8, 2005.
- Fouad MN, Acemgil A, Bae S, et al: Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials. J Oncol Pract. 12:556-63, 2016.