Diversity and Inclusion in Clinical Trials
An Insider’s View
@DrugInfoAssn
ustained integration of diversity and inclusion in clinical trials and drug development will require more than just outreach to marginalized and underrepresented communities when their participation is needed by the scientific community. To achieve genuine equity and inclusion, we must make long-term structural changes in the science of medicine and drug development. In highly heterogeneous communities, it is important to ensure similar diversity is included and represented in the populations tested within each clinical trial.
In a fireside chat at DIA’s Diversity, Equity, and Inclusion in the Drug Development Lifecycle Meeting in April 2021, Robert Fullilove, Associate Dean for Community and Minority Affairs, and Professor of Clinical Sociomedical Sciences at Columbia University, provided insight into the changes that are needed to build a fully inclusive process from the perspective of someone who knows underrepresented communities from the inside.
Build Scientific Literacy and Trust
Robert Fullilove remembers a 1983 landmark report on the American education system that contributed to the notion that American schools were failing and discussed education reform. In it, he recalls a description of the United States as not doing the job of giving the American public the exposure to science and technology that it absolutely needed. During the fireside chat, he states, “what we’re living with now in 2021 was foreseeable way back in the 1980s.” Fullilove estimates that the average scientific literacy level has been going down over time, and the problem is nationwide and not specific to communities of color.
To help build scientific literacy, communities that have been historically underrepresented and poorly treated in health and healthcare must have a sense that science touches their lives. Fullilove strongly recommends that researchers engage in community-based participatory research to build a shared understanding of their problems and challenges in a given community. According to Fullilove, that understanding then informs “the way we do science.” “The more the community sees visible input and efforts to promote a scientific objective, the more they will believe that [researchers] trust their voice and their wisdom.”
Restructure Medical Education
In the context of how race is misrepresented in medical schools, Fullilove emphasizes the importance of physician training, how it contributes to physician bias, and how the physician experience parallels those that exist in the drug development lifecycle. He refers to the dawn of slavery, when the justification for human bondage was based on the belief that the people who were enslaved where vastly different from those who enslaved them.
He adds that physicians are still trained to approach communities that are not familiar as if they are fundamentally different from their own, and that this approach does a dramatic injustice to these communities and their patients. One example Fullilove highlights is “the idea that doctors don’t believe [the] accounts that people of color give them, especially Black and LatinX populations. If you ask me to describe what happened to me, and then you do not believe the narrative that I provide, this simple inability to communicate something that you need to know as a physician, but I [as a patient] cannot convince you is true, means [to me] that maybe I’m in the wrong place talking to the wrong person.”
Activate Diverse Communities and Understand What They Want
Fullilove advises sponsors to be present as a helper rather than as someone who is merely interested in recruiting. “It is important for those involved in the drug development lifecycle to be present now, when intense efforts are needed for community recovery from all the losses that have been incurred in black and brown communities as a result of COVID-19.”
Robert Fullilove, EdD., is Associate Dean for Community and Minority Affairs and Professor of Clinical Sociomedical Sciences at Columbia University as well as Co-Director of the Cities Research Group.
Fullilove’s grandfather treated the Spanish Flu in the Mississippi Delta in 1918. His father, aunt, and uncle survived having the Spanish Flu; his grandmother did not. It was clear to Fullilove early on that his father’s decision to enter medicine was largely a function of what happened to his grandmother in that first viral flu epidemic – one Fullilove observes echoes the COVID-19 pandemic.
Fast forward to 1964, when Fullilove gained experience as a community organizer, operating as a field secretary for the Student Non-Violent Coordinating Committee (SNCC) and working under the late civil rights leader and Georgia Congressman John Lewis. In 1986, he shifted to public health, focusing on HIV and AIDS research. In 1998, he was appointed to the Advisory Committee on HIV and STD Prevention (ACHSP) at the Centers for Disease Control and Prevention (CDC), and in 2000 became the committee’s co-chair.
The background of Robert Fullilove’s family in medicine, his work in community organizing, and his expertise in public health as a faculty member at Columbia University since 1991 have given him a unique point of view on our awareness as a nation of how racism has driven the health of the public.
“The most important thing for those of us who do this work is the issue of trust. If we do not see you in a community, why should we trust you when you come in offering us goods and services?” Fullilove points out. The issue of trust, engaging diverse communities, and having confidence in science is a tremendous challenge.
It is important for industry sponsors to demonstrate genuine concern for what happens in a community, asking community members what sponsors as individuals and organizations can do to help. Working with a gatekeeper who is an active and trusted member of the community is a critical step towards understanding the community’s true needs.
In the short term, diversity in clinical trials is best achieved by working in and with communities that are representative of the population as a whole.
“When [industry is] putting together a sample or clinical trial that is intended to be diverse, [industry sponsors] always choose communities where you have the densest population of black people.” According to Fullilove, those who are trying to engage these types of communities often fail to realize that some people are so “engaged in the day-to-day survival of everyday life [that] their likelihood of wanting to take time off to volunteer to be in a clinical trial is probably going to be much less than [people who live] in diverse communities.”.
To make real progress toward achieving true diversity and inclusion in clinical trials, the healthcare sector must take action. Building scientific literacy and trust, restructuring medical education, and understanding diverse communities’ true needs are important and powerful ways we can have a true impact.