You have a compound for the treatment of NASH. Now what? (Pt. 3 of 3)

This is part 3 of a 3-part series.

You can find part 1 here and part 2 here.

Series Overview

One primary barrier to getting new drugs to market is the inability for sponsors to enroll their clinical trial. With more than 70 investigational NASH drugs in development across more than 60 sponsors, the next 5 years* will see the need for at least 30,000 patients to enroll in clinical trials. The success (or failure) of your compound literally depends on meeting your enrollment milestones.

In this series, Continuum Clinical will pull from its more than 25 years of clinical trial enrollment experience to discuss the NASH patient journey, educational and awareness opportunities—including those specific to underrepresented patient populations—and other challenges associated with reaching and motivating this unique patient population. Ultimately, we will provide clear insights about what is necessary to help sponsors meet or beat their enrollment milestones for NASH clinical trials.

Part 3: The Importance of Creating Hispanic-Specific NASH Campaigns

As we’ve been discussing, NASH is certain to bring its own unique barriers when it comes to successful clinical trial enrollment: little to no awareness of the condition, no universal patient experience, and invasive liver biopsies—just to name a few. But one that clearly can’t be ignored is the need for developing specific, culturally-relevant recruitment campaigns that resonate with Hispanic/Latino patients.

We already know that NASH is affecting the Hispanic population at a far more disproportionate rate than any other ethnic group. While that’s not something that we can change, we will be able to have a direct impact on how we motivate the Hispanic/Latino population to participate in NASH clinical trials through messaging and campaigns that resonate culturally.

There is no doubt that building sponsor credibility will be vital with any NASH clinical trial due to a lack of awareness of the disease among both patients and physicians, which may lead to an overwhelming grief period for a patient after diagnosis. But it’s going to be especially important to overcome specific cultural barriers within the Hispanic/Latino community in order to build credibility and motivate participation in NASH clinical trials.

Currently, Hispanics make up 18% of the US population but only 1% of clinical trial participants.¹ It is critical to understand and address some of the cultural barriers that may be contributing to the lack of clinical trial participation for Hispanics. This community places a high value on spending time with family. In many cases, this “family-first” philosophy can actually keep patients from seeing a doctor. Hispanics and Latinos are more likely to say, “It is difficult for me to leave home due to family care responsibilities” as a barrier to seeking medical care. Another barrier is not being able to access care locally with physicians and nurses who speak Spanish. Lastly, health advocates nationwide report an increase of fear within the Hispanic community – regardless of immigration status – when accessing healthcare services.²

Given these cultural barriers, there are many opportunities for sponsors and CROs to design NASH studies to specifically address these barriers.

So how can we do this?

Planning to be inclusive should start as early as site selection, where there is a need for sites to be located within predominantly Hispanic/Latino communities to ensure a high level of sensitivity and familiarity at the study site level. At a minimum, site personnel should include Spanish-speakers. We can’t overemphasize the importance of patients and their families feeling welcomed and connected to the site and the staff. In cases where there are no Hispanic/Latino site staff available, we recommend site-level cultural sensitivity training to facilitate mindful interactions between staff and potential patients.

To successfully gain credibility with Hispanic/Latino NASH patients, study materials will not just need to be in Spanish, but developed and written in a way that truly demonstrates a high level of understanding of the cultural nuances of the Hispanic community. Additionally, outreach materials will need to speak not just to the patient but to the entire family—to truly resonate with this family-first community.

Equally important will be creating culturally-relevant advertising and outreach tactics utilizing media channels like Univision and Telemundo that are important to Hispanic/Latinos. Spanish language media are especially relied upon for more than just news and entertainment. Many viewers are also seeking health, education, finance, and civic engagement information via these channels. These stations and their on-air personalities are seen as highly trusted members of the community. Consider that 49% of Spanish-dominant Hispanics and 27% of English-dominant Hispanics say, “When I hear a company advertise in Spanish, it makes me feel like they respect my heritage and want my business”. ³

Grassroots engagement opportunities such as health fairs and other community events will also be valuable avenues for educating and building awareness of NASH and the importance of clinical trial participation. Directly engaging Hispanic/Latino patients through educational and community events is critical to connect with patients before and after diagnosis. Community-level engagement, especially important to populations typically underrepresented in clinical research, will ensure Hispanic/Latino NASH patients receive education and information at the right time in their journey and can make recruitment campaigns more effective.

Our research did suggest that there is something for enrollment teams to be buoyed by: Hispanic/Latino interest in NASH clinical research participation.

According to proprietary research conducted by Continuum Clinical, Hispanic/Latino communities have already shown an increased interest in NASH clinical research—62% versus 49% of total number surveyed.3 Furthermore, the known barrier of invasive liver biopsies surprisingly appears to be far less concerning than in comparison to other ethnicities.⁴

This increased interest, coupled with the increased prevalence of NASH, underscores the need to prioritize a strategy that is tailored specifically to reach the Hispanic/Latino community to be incorporated into the overall recruitment campaign.

References:

1) FDA, National Institute of Health, Office Minority Health

2) United States Census Bureau Report, 2012; American Heart Association Report, 2014; Elejalde-Ruiz, Alexia, Chicago Tribune article

Fear, anxiety, apprehension: Immigrants fear doctor visits could leave them vulnerable to deportation; February 22, 2018

3) Simmons NHCS, Spring 2017 (top 2 box)

4) Continuum Clinical. 2019 Patients at High Risk for NASH Insights and Awareness Survey; 2019. [Survey results pending online publication].