Ideally, the patients participating in a given clinical trial should be wholly representative of the typical demographic impacted by the disease being studied. Thus, the medication or treatment being developed would take into account the complex factors presented by common genetic variations present in different races, and also affected by gender and age. However, this is not the case and there is rampant disparity of diversity in clinical trials. In a recent webinar, panelists explored this topic from the perspective of cultural diversity and patient advocacy.
First, it’s important to define what is meant by cultural diversity.
“It’s not always about race – it’s about culture and what goes beyond race – it’s about education and values that are part of a person’s identity,”
explained Luke Kramer, Executive Director, The STARR (Stakeholders in Treatment, Advocacy, Research and Recovery) Coalition. While demographic factors include the characteristics of a given population such as age, sex, ethnicity, education level, income level, occupation, marital and family status, and sexual orientation, cultural diversity delves deeper into an individual’s personal experience, social constructs and heritage. Culture goes to the core of integrated patterns of thoughts, communication, actions, customs, beliefs and values influenced by institutions of racial, ethnic, religious, social or other groups.
To match the racial and ethnic makeup of a particular trial population for a specific disease, it’s imperative to create awareness through educational and informational materials that resonate within the targeted population pool. Success is incumbent upon understanding the foundations of cultural competency. There is no one, overarching definition. The National Center for Cultural Competence at Georgetown University defines cultural competency, in part, as “…a set of congruent behaviors, attitudes, and policies that come together in a system, agency or among professionals and enable that system, agency or those professionals to work effectively in cross cultural situations.” 1. Becoming culturally competent enables staff tasked with enrolling patients in clinical trials to bridge the gap between their organization and the communities they serve.
Carlos A. Larrauri, APRN, Lecturer at the Miami School of Nursing and Health Studies, who also serves on the Board of Directors for the National Alliance on Mental Illness, advised that healthcare organizations conduct self-assessments as a way of identifying biases that can impede policy making and administrative decisions that may negatively impact the ability to adapt to the cultural diversity in their local communities.
A lack of diversity in clinical research impedes the ability to generalize study results and make medical advancements in effective therapies. The FDA reports that “Of the participants in trials of drugs approved in 2015 and 2016, 78.6% were white, 11.8% were Asian, 5.4% were black of African American, and 3.8% were listed as other.” 2. How can patient advocacy groups (PAGs) and clinical research sites work together to move the needle on cultural diversity in clinical trials?
PAGs can serve as the voice of the patient in clinical trials and:
- Participate in study design, recruitment, research prioritization, funding strategies, and dissemination of research results
- Educate potential participants about the value of clinical trials through existing websites, advertising and community outreach in underserved populations
Lorenzo Lewis, MBA, founder of The Confess Project, a social impact agency providing mental health programming for boys and men of color, discussed the power of using social media platforms to integrate content and craft effective communication. “The ways we show up are truly important. Building ally trust and support assists with bringing messaging to the community,” Lorenzo said.
There are unique barriers between clinical researchers and the diverse communities they hope to serve. Luke suggested “Bring the right individuals in your organization and have a brainstorming session. Pull in more diverse staff to fill in the gaps. Narrow the list to the most important things you need to address and then create strategies to address them from the inside, out of your organization to become culturally competent.”
Two keys to successful clinical trials are highly targeted digital and traditional advertising and knowledgeable enrollment support. Our Marketing and Design department works with a patient-centric mindset when designing educational and promotional materials. Our Patient Enrollment Specialists carefully review each study protocol before pre-screening patients and communicate compassionately and clearly.