As Hispanics lag in clinical trials, health researchers take action: Outreach expands ===================================================================================== * Natalie McGill There are 53 million Hispanics living in the United States today. That number is expected to grow, reaching more than 128 million by 2060, the U.S. Census Bureau predicts. Also growing is the disproportionately high number of Hispanics living with chronic conditions such as high blood pressure, diabetes and cancer. But when it comes to representation in clinical trials that could result in life-saving treatments, growth among Hispanics remains to be seen. That lack of representation has public health professionals researching reasons why numbers are so low. Some have found tools to reverse the trend, but they predict a long road ahead before there is nationwide progress. In general, minority populations such as blacks and Asian and Pacific Islanders are poorly represented in clinical trials, despite suffering higher rates of preventable chronic illness such as diabetes and hypertension. But reaching Hispanics in the U.S. presents a unique set of challenges for public health practitioners, ones that may include language barriers, concerns about immigration status or a different cultural view on the benefits of medical care. While minorities make up 30 percent of enrollees in National Institutes of Health clinical trials, Hispanics make up 7.6 percent of participants, compared to 15 percent of blacks, according to NIH. And with cancer as the leading cause of death among Hispanics, Hispanic cancer patients only make up 2 percent to 5 percent of participants in cancer clinical trials in the U.S., according to the National Cancer Institute, which has more than 12,000 trials accepting participants. While there are first-, second- and third-generation Hispanics who have assimilated into U.S. culture, adult immigrants may struggle with English, said Jorge Gomez, MD, PhD, director of the National Cancer Institute’s United States-Latin America Cancer Research Network. Some of them may work in jobs with partial insurance coverage that they are concerned about using, or that might not cover the cost of participating in a trial. Gomez said religion and family can also play a role in participation. Some Hispanics may place a greater priority on faith than scientific data, and they may want to include family as a part of their medical decisions, he said. In some Hispanic families, Gomez said it is typical for two or three family members to want to sit in on a doctor’s visit. Gomez said that while this might seem like barrier to a physician seeking one-on-one time with a patient, involving multiple family members is something clinical trial investigators must embrace if they want to recruit more Hispanics for clinical trials and get them to stick to treatment and follow-up visits. “We need to be a little bit more sensitive to these issues,” Gomez said. “This is a portion of the U.S. population that is here and they need our attention, our care. I think all of that is very important in terms of attending to the culture.” Venus Ginés, MA, an instructor on cultural competence and health literacy at the Baylor College of Medicine, said that a clinical trial investigator must not only realize the barriers Hispanics face in accessing trials, but get an education about culturally appropriate ways to gain the trust of Hispanic communities in the U.S. Ginés, founder of Día de la Mujer Latina, a Pearland, Texas-based outreach and advocacy group for the health of Hispanic communities, created a program in 2011 to train existing “promotores” — members of the Hispanic community who have received health education and act as community liaisons —as clinical trial navigators. The navigators have an understanding of culture, such as the importance of involving faith and family in medical decisions, and relate as people who have been Hispanic patients in the U.S., she said. Ginés said the training is bilingual, reflects national standards for culturally and linguistically appropriate care and promotes understanding of the disease the clinical trial focuses on. “You can’t just say, ‘This is a great idea for you to participate in this clinical trial,’ and leave it at that,” Ginés said. “You need to constantly give the updates, the impact they’re making by being in this clinical trial and motivate them to stay in the clinical trial.” Patient navigators were used to recruit participants in a NIH-funded clinical trial for breast and cervical cancer treatment that ran from 2008 to this year, said Melissa Simon, MD, MPH, an APHA member and associate professor at the Northwestern University Feinberg School of Medicine. Out of 500 women, 70 percent of the participants were Hispanic women, which Simon credits the navigators for. She said the navigators were important to creating a community bond and tackling patient barriers such as transportation, especially because the study targeted uninsured women spread out among Chicago suburbs. ![Figure1](http://www.thenationshealth.org/http://www.thenationshealth.org/content/nathealth/43/7/1.2/F1.medium.gif) [Figure1](http://www.thenationshealth.org/content/43/7/1.2/F1) Seventy-five percent of Hispanics would participate in a clinical trial if their doctor recommended it, according to a July poll. Photo by Mark Bowden, courtesy iStockphoto “They were generally wanting to help these women in any way they could,” Simon told *The Nation’s Health*. “They spoke the same language. They were from the same communities. And they had the right personalities to communicate clearly and that trust and rapport with participants.” But there are challenges that come with trying to boost participation. Ginés, who serves on a number of health boards and steering committees in Texas, said she has yet to see any state health agencies pay for training, despite the state’s large Hispanic population. Hispanics are willing to participate in clinical trials if they are given two things: communication and information, Ginés said. Seventy-five percent of Hispanics would participate in a clinical trial if their doctor recommended it and 38 percent of Hispanics said health care providers have a responsibility to inform their patients about clinical trials, according to a July Research!America poll. With a growing Hispanic population, there may be more cases of cancer and chronic disease, and physicians may not know about appropriate therapies or clinical intervention because there is not adequate information, she said. Ginés said that Texas medical professionals who do not respond to the lack of Hispanic participation now could face difficulties in trying to engage Hispanic communities in the future. She said residents in those communities might not be as trusting. “Build that relationship, so when you apply for a project, they’ll trust you,” Ginés said. Simon said she does not see the Hispanic participation rate in clinical trials increasing soon because of the Affordable Care Act. Under the law, legally documented immigrants who have lived in the U.S. for fewer than five years are ineligible for Medicaid coverage. That means some low-income Hispanic families may be unable to access the medical centers where trials are offered. “That’s a big problem,” Simon said. “And if public health practitioners are working on strategies to figure out how to address this problem, how do you get a Latino who is not eligible for insurance coverage under the ACA into a clinical trial? How do you do that when they might not potentially be going to the hospital, except for the emergency room in some places?” Seeing the importance of having culturally sensitive approach to recruitment, more than 300 public health professionals, researchers and community advocates nationwide joined forces to form Eliminating Disparities in Clinical Trials, or EDICT, in 2005, a project housed at the Baylor College of Medicine’s Chronic Disease Prevention and Control Research Center in collaboration with the Intercultural Cancer Council. From 2008 through 2009, a series of community meetings were held across the country, which gauged communities on what health professionals need to consider when recruiting minorities for trials. Project members developed a list of policy recommendations, such as that NIH and the Food and Drug Administration should provide incentives to clinical trial investigators who have inclusion plans to recruit minorities. Other suggestions were that federal and privately funded clinical trial sponsors should adopt national standards and that local clinical trial teams create recruitment and retention committees to make sure people complete the trial. Gomez said having minority clinical trial investigators could also help in making underrepresented populations more likely to participate in trials. He also suggested that institutions that conduct clinical trials partner with community hospitals to recruit participants because that may feel more accommodating to the Hispanic population. Representation of Hispanics who hail from different countries in clinical trials is what will lead to better treatment for Hispanics in the future, he said. “There are a lot of benefits to participating in clinical trials and (Hispanics) need to understand that,” Gomez said. “They need to know in an appropriate way.” For more information on clinical trials and Hispanics, visit [www.cancer.gov](http://www.cancer.gov) or [http://diadelamujerlatina.org](http://diadelamujerlatina.org). * Copyright The Nation’s Health, American Public Health Association