Pharma Challenged to Include Hispanics in Clinical Trials

By Norma A. Mendoza

Hispanics and Clinical TrialsA 2016 Pew Research Center study predicts the upcoming presidential election will see the highest ethnic and racial diversity in history. The recent growth in Hispanic eligible voters is undoubtedly a direct result of the charged rhetoric of the presidential campaign. As immigration reform has dominated mainstream debate, Hispanics have been targeted in verbal – and sometimes physical, attacks that have mobilized communities across the U.S.

As the fastest growing minority group in the United States, Hispanics are on pace to also become the largest minority group nationwide, projected to be 25 percent of the population by 2020.  As the youngest demographic group in the U.S., with a reported purchasing power of 1.5 trillion dollars, major companies have allocated significant resources to researching the needs and purchase patterns of this attractive demographic. While marketers recognized over a decade ago the need to understand this group, other sectors are just now scrambling to do so. Consider the healthcare industry. Both medical and pharmaceutical research suggests this population is severely underrepresented in clinical trials (e.g. Gonzales, Quinn, McIntyre, 2010) (1). A 2004 study reported that from 1996 to 2002 Hispanics were only 3.1 percent of participants in clinical trials for breast, lung, colorectal, and prostate cancers (Murthy, Krumholz, and Gross, 2004) (2). Given well documented racial/ethnic genetic predispositions towards certain illnesses, as well as differential response to certain medical treatments, the question at hand is: how do we overcome the underrepresentation in medical and pharmaceutical research of the fastest growing minority group in the U.S.?

Cultural Competency and Methodological Considerations

¿Habla Español?
The first and most obvious issue to consider is one of language. A significant number of U.S. Hispanics are consumers of Spanish-language media and/or speak Spanish at home and within their circle of friends. Still, medical and pharmaceutical research has been slow to adopt data collection instruments in Spanish. Moreover, many would not be able to identify nuances in Spanish spoken by Hispanics of Mexican descent and those of Cuban or Puerto Rican background. Symptoms and illnesses may be described differently by each of the groups, leading to different diagnosis and treatment. Stroke, for instance, is commonly known as derrame cerebral – literally brain hemorrhage, but is also known as embolia, or paro cerebral –or a brain stoppage. The latter could lead some to misinterpret it as failure of mental faculties. Failing to account for language nuances may yield unreliable findings that will lack generalizability. More importantly, language preferences can have more serious and long-lasting side-effects. According to DuBard and Gizlice (2008) “Spanish-language preference marks a particularly vulnerable subpopulation of U.S. Hispanics who have less access to care and use of preventive services.” (3)  In the absence of linguistically competent service providers, researchers and instruments, this population will remain out of reach.

A Qualitative Quality

Cost considerations and time constraints often play a part in our choice and recommendation of methodological approach. However, when it comes to understanding the Hispanic population, Curry, Nembhard and Bradley (2009)(4) explain how qualitative methods in general, and in-depth interviewing in particular, provide rich insights into special and often underrepresented populations. According to Currey et al., “interviews are particularly useful when rapport between the researchers and respondents is required to ensure candor, or in instances when privacy may alleviate fear of reprisal for negative statements, such as program evaluation or patient satisfaction studies." When dealing with Hispanics, the need to gain trust and establish rapport can’t be underestimated. Historical events have led to a general mistrust of medical-related research. The test of contraceptives among Puerto Rican women in the 1950’s resonates with Hispanics of all backgrounds; there is a great reluctance to being treated as guinea pigs. In order to overcome such mistrust, researchers need to become culturally competent, taking the time to understand Hispanics’ health belief systems and practices in their research if this is to yield actionable insights. Take, for example, the choice between in-depth interviewing and focus groups. A series of guided one-on-one conversations is more likely than a focus group to yield reliable and actionable insights. The researcher will be able to tap into latent attitudes and beliefs in a respectful and non-confrontational manner. When potentially embarrassing or sensitive health issues are discussed in a focus group setting, the potential for bias is introduced given this population’s susceptibility to social influence. Moreover, a semi-structured guided-conversation allows for high-context communication common of Hispanic culture. An interviewer familiar with the culture will be able to interpret meaning in tone of voice or non-verbal cues and probe the informant for clarification. As explained by Curry et al., these "interviews are highly interactive. The interviewer aims to be responsive to the language and concepts used by the interviewee."

Permanent Diversity

cultural diversity is a permanent reality.Clearly, there are numerous other issues to consider when conducting research with underrepresented racially and ethnically diverse populations. The most important take away is the recognition that a demographic trend reversal is unlikely in our lifetime: cultural diversity is a permanent reality. Cultural competency, including language competency, must permeate recruitment, sampling, data collection, and analysis in health-related research. As researchers, we have a great opportunity to take the lead in educating the healthcare delivery system on how cultural beliefs shape patients/consumers’ perceptions of their own health and healing; the causes of illnesses and beliefs about treatment effectiveness; and attitudes towards health-care providers.

As pointed out by the Office of Minority Health in a 2010 study:

"Although many aspects of health in the United States have improved over the past several decades, significant racial and ethnic disparities remain. Public perceptions—and misconceptions—about racial and ethnic differences in health status can influence the actions of policy-makers in addressing the problem. Although persistent disparities in health status and health care have been well documented, data indicate that the general public (including racial and ethnic minorities, health care providers, and policy- and decision-makers) is uninformed about the nature and extent of such disparities."(5)

It might not be inaccurate to count the research industry among those uninformed of such disparities. Nevertheless, in developing the capacity to value and adapt to diversity, we have the potential to play a very important part in achieving a solution. Hopefully you will agree that this is a win-win situation all around: for the populations that will have their health needs better met; for our clients who aim to provide better health care services and treatments; and why not, for our bottom line, as there is extensive work to be done before the healthcare delivery system achieves the level of institutional, cultural knowledge required by the current demographics.

Norma A. Mendoza, PhD is the President of MerKadoTeknia Research & Consulting LLC, a company that specializes in crafting marketing strategy based on consumer insights to drive results.


  1. González, L.E., Quinn, G.P. & McIntyre, J. (2010). "Barriers to Participation in Clinical Trials among Hispanic Cancer Patients. "Undergraduate Research Journal for the Human Sciences, 9.
  2. Murthy, V., Krumholz, H. & Gross, C. (2004). "Participation in Cancer Clinical Trials: Race, Sex, and Age-Based Disparities. "Journal of the American Medical Association, 291(22), 2720.
  3. DuBard, C. & Gizlice, Z. (2008). "Language Spoken and Differences in Health Status, Access to Care, and Receipt of Preventive Services Among U.S. Hispanic. “American Journal of Public Health, 98(11), 2021-2028.
  4. Curry, L., Nembhard, I.M. & Bradley, E. H. (2009). "Qualitative and Mixed Methods Provide Unique Contributions to Outcomes Research. "Circulation, 119, 1442-1452. The online version of this article, along with updated information and services, is at
  5. For additional information on the NPA, please visit Furthermore, specific information on OMH’s approach to eliminating health disparities can be found in its Strategic Framework available at

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