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COMMENTARY 

What Do We Want? Increased Hispanic 
Accrual on Cancer Clinical Trials! 
When Do We Want It? Now! 
Brian O. Warnecke1 , Anand B. Karnad1 , Ian M. Thompson, Jr2 

1Mays Cancer Center, UT Health MD Anderson, San Antonio, TX 78229 and 
2CHRISTUS Santa Rosa Hospital - Medical Center, Texas Urology Group, San Antonio, TX 78229 
 
*Corresponding author: Brian Warnecke, warneckeb@uthscsa.edu 

ABSTRACT 
The Hispanic population is one of the fastest growing racial/ethnic group in the United States. Cancer is 
leading cause of death in this demographic group and have up to 50% higher cancer mortality rates 
compared to the non-Hispanic white population in the United States. Hispanics face numerous cancer 
health disparities, including poverty, obesity, and access to health care and insurance. In our previous 
study, we noted a poor Hispanic accrual rate of 3.9% in all phase II and III cancer clinical trials published 
in the United States in 2012 and argued for better representation. To assess if a change was made seven 
years later, we reexamined the clinical trials published in the United States in 2019. We found 48 cancer 
clinical trials meeting our inclusion criteria. Only 23 (48%) reported information regarding minority accrual. 
Of these, 8 (17% of all) reported Hispanic accrual. Altogether, of the 2559 patients reported in the 8 clinical 
trials, 104 (4.1%) were of Hispanic ethnicity, which nearly matches the 3.9% that we reported in 2014. In 
this manuscript, we highlight the disproportionately low rates of Hispanic accrual in cancer clinical trials 
and propose processes that will increase representation. 

KEYWORDS: Hispanic, clinical trials, health disparities, socioeconomic status 

Citation: Warnecke BO et al (2021). What Do We Want? Increased Hispanic Accrual on Cancer Clinical 
Trials! When Do We Want It? Now! Cancer Health Disparities. doi:10.9777/chd.2021.1001 
 
 
  



 
 
 
 
 

 
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Hispanics constitute the fastest growing 
demographic group in the United States and 
represented 18.5% of the US population in 2019 
(Census Bureau QuickFacts, 2020). By 2050, the 
number of Hispanics in the U.S. is expected to triple 
from 46.7 million to 132.8 million and will represent 
about 30% of the US population (Haile et al., 2012). 
Although Hispanics have lower rates of the four 
most common cancers (breast, colorectal, lung, and 
prostate cancer) than their non-Hispanic white 
counterparts, this ethnic group has higher rates of 
cervical, gallbladder, liver, and gastric cancers. In 
addition to higher prevalence of these cancers, they 
have up to 50% higher cancer mortality rates 
compared to the non-Hispanic white population. 
Cancer is the leading cause of death among 
Hispanic/Latinos (Haile et al., 2012). 

Hispanics face significant cancer health disparities 
due to several factors. Poverty, access to care, and 
obesity play major roles in Hispanic cancer 
predisposition and higher cancer-mortality rates. 
Hispanics are the least likely to have health 
insurance of any racial or ethnic group; among 
those 18-64 years of age, 25% of Hispanics were 
uninsured during 2016-2017 compared to 9% of 
non-Hispanic whites (Hales, 2018). In 2015-2016, 
80% of Hispanic adult females and 83% of Hispanic 
adult males were overweight or obese, compared 
to 65% and 74% of their non-Hispanic white 
counterparts. Obesity likely plays a significant role 
in cancer risk in this population (Hales, 2018). 

We have previously highlighted the poor Hispanic 
accrual rate of 3.9% in cancer clinical trials 
published in 2012 and raised an alarm urging 
actions to increase Hispanic accrual (Parra et al., 
2014). At that time, we examined Hispanic accrual 
to phase II or phase III cancer clinical trials in the US 
published in 2012. We identified 159 clinical trials, 
only 33 of which presented data regarding patient 
ethnicity. Only 13 of those 33 studies stated rates of 

Hispanic accrual, a mere 8.18% of all phase II or III 
cancer clinical trials in the US. The problem was 
clear as was the solution: an increased focus on 
Hispanic accrual, universal reporting on how 
representative the trials are of the U.S. population, 
and the need for improvement. 

Seven years later, we have reexamined our national 
response. We examined all phase II and phase III 
cancer clinical trials published in 2019 by clinical 
investigators in the US. We identified studies 
published in one of the following journals: The New 
England Journal of Medicine, Journal of Clinical 
Oncology, Journal of the National Cancer 
Institute, Lancet, and Blood. We collected data 
related to reports of patient ethnicity, patient 
accrual, and Hispanic enrollment. We found 48 
cancer clinical trials that met these inclusion criteria. 
Of these, only 23 (48%) reported information 
regarding minority accrual; of this group of 23 
reports, 8 (17% of all) reported Hispanic accrual. 
Ultimately, of the 2559 patients reported in the 8 
clinical trials, 104 (4.1%) were of Hispanic ethnicity, 
almost exactly the same fraction (3.9%) that we 
reported in 2014. 

Although these data demonstrate an increase in the 
number of clinical trials reporting minority and 
Hispanic accrual, the proportion of Hispanics 
participating in clinical trials remains minimal. This 
plateau in low rates of Hispanic accrual to cancer 
clinical trials is disconcerting and demands action. 

While the need for broad population representation 
in clinical trials seems self-evident, we should stress 
the rationale: with significant differences in risk 
factors, access-to-care, cultural and other variables 
related to cancer outcomes in the racial and ethnic 
groups in the U.S., we must be sure that conclusions 
we reach regarding cancer management can be 
generalized for all Americans. We do recognize that 
the challenges to cancer clinical trial accrual are 



 
 
 
 
 

 
www.companyofscientists.com/index.php/chd e3 Cancer Health Disparities 

COMMENTARY 

complex and will require multi-level systemic 
changes. However, amidst these challenges is an 
opportunity: As cancer is highly related to age, the 
absolute number of cancer cases among Hispanics 
in 2020 is disproportionately lower than their 
current population. However, while 8.4% of the 65+ 
U.S. population in 2018 was Hispanic, this group will 
constitute 21% of the 65+ population in 2060. (Frey, 
2018). Every effort to enhance the accrual of 
Hispanic elderly with cancer will translate into better 
quality of evidence for treatment decisions in this 
group. We thus have a unique opportunity to, as 
Bobby Orr quipped, ‘skate to where the puck will 
be’ now and establish how to best provide cancer 
care for Hispanics rather than react years from now 
without data. 

We propose three simple steps to catalyze this 
process. First, minority recruitment plans for cancer 
clinical trials must include specific plans for Hispanic 
accrual. Second, journals should require data 
related to Hispanic accrual in demographic tables 
(classically, ‘Table 1’). Finally, an annual ‘National 
Report Card’ should provide Hispanic accrual for all 
trials registered at clinicaltrials.gov. Indeed, these 
are steps that can be applied to enhance clinical trial 
accrual in all underrepresented minority groups. 
We are confident that these simple steps will place 
a bright light on the issue and will ensure that, over 
time, we will enhance cancer care of this important 
group of our fellow citizens. 

 

ACKNOWLEDGEMENT 
This publication was supported by the NIH/NCI 
Cancer Center Support Grant (CA054174) at the 
University of Texas Health, San Antonio, TX. 

Conflicts of interest 
There are no conflicts of interest for any authors. 

Authors' contributions 
BW, AK, and IT conceptualized the study. BW 
collected the primary data. BW, AK, and IT 
conceived analysis and interpretation of the data. 
BW, AK, and IT wrote and edited final abstract. 

REFERENCES 
Census Bureau QuickFacts. 2020. U.S. Census Bureau 

Quickfacts: United States. [online] Available at: 
<https://www.census.gov/quickfacts/fact/table/US/RHI72
5219> [Accessed 9 August 2020]. 

Frey, WH. “The US will become ‘minority white’ in 2045, Census 
projects.” Brookings Institution. 2018. 
https://www.brookings.edu/blog/the-
avenue/2018/03/14/the-us-will-become-minority-white-
in-2045-census-projects/. Cited 9/16/2020 

Haile RW, John EM, Levine AJ, Cortessis VK, Unger JB, Gonzales 
M, et al. A review of cancer in U.S. Hispanic populations. 
Cancer Prev Res (Phila). 2012 Feb;5(2):150-63. 

Hales CM. National Health and Nutrition Examination Survey 
Data, 2015-2016. Obesity in ages ≥20 years. [online] 
National Center for Health Statistics. Available at: 
<https://www.cancer.org/content/dam/cancer-
org/research/cancer-facts-and-statistics/cancer-facts-
and-figures-for-hispanics-and-latinos/cancer-facts-and-
figures-for-hispanics-and-latinos-2018-2020.pdf> 
[Accessed 1 August 2020]. 

Parra A, Karnad, AB, Thompson IM. Hispanic accrual on 
randomized cancer clinical trials: A call to arms. J Clin 
Oncol 2014; 37:1871-1873.  

 


	ACKNOWLEDGEMENT
	Conflicts of interest
	Authors' contributions

