An ‘urgent need’: Steps to increase black participation in diabetes clinical trials
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Data from clinical trials show that findings often do not apply to minority populations, and trialists must adopt cultural competency practices to recruit and retain black participants, according to a speaker.
“It is very sobering that in the excitement of the recent advancements signaled by the cardiovascular outcomes trials with modern diabetes drugs, it turns out that the cardiovascular outcomes were not significant for blacks in these pivotal trials,” James R. Gavin, MD, PhD, chief medical officer of Healing Our Village and clinical professor of medicine at Emory University School of Medicine in Atlanta, Georgia, said during a presentation at ENDO Online. “It turns out the P values were nonsignificant for superiority under all circumstances. This is disturbing, because it leaves unanswered the question, why? Is it because the sample size was insufficient, or was there truly a lack of effect?”
Often, clinical trial data are confounded by the fact that global trials do not emphasize the recruitment of black adults as a priority population, Gavin said. This means that health care providers are limited in what they can say with confidence to high-risk populations about particular study interventions.
“There are several strategies that we need to embrace to meet some of these unmet needs arising from inadequacies in clinical trials,” Gavin said. “We need better real-world evidence and better recruitment strategies for disproportionately affected populations.”
‘The moral imperative’
There are multiple groups for whom researchers have insufficient information about drug efficacy or safety from broad-based clinical trials, Gavin said. Racial and ethnic groups represent simply one of them. Historical oversight and omissions have led to many of the gaps observed in clinical trials data, he said.
“There is a theme of consistency,” Gavin said. “If one looks at hospital admissions for acute complications of diabetes among adults, from 2001 through 2006, what they show is the enormous disproportion for adverse outcomes for blacks vs. whites or other groups. Sadly, we see similar patterns persist for COVID-19. There is a significant disproportion today in the deaths among blacks, and this is well beyond our representation in the population across the US. In fact, early data showed that the [COVID-19] death rate was twice as high in blacks and Latinos vs. whites in new York.”
“This kind of data highlights the moral imperative for making sure that minorities are in fact represented in such clinical trials,” Gavin said. “If not, there is a question of whether or not the results from these studies are going to be relevant or safe for everyone across the board.”
Creating relationships
A person’s willingness to participate in a clinical trial is a function of multiple factors, including their awareness, sense of appreciation for the study, education, expectations, study environment and communication, Gavin said. Inversely, there is a relationship between the perceived risks in the study or the perceived inconvenience, Gavin said.
“You have to increase the elements of the numerator while you decrease the elements of the denominator,” Gavin said. “This is particularly important when there is a perception of peril or discouragement from participation or some level of distrust, as is often the case in minority communities,” Gavin said.
Cultural barriers between the investigator and the participant can severely hamper even the best of efforts at effective communication, Gavin said.
“This simply means that we have to assure that there are ample and appropriate levels of cultural competence as a core component in successful recruitment strategies,” Gavin said.
Cultural competence begins with valuing diversity beyond talk, Gavin said — conduct self-assessments, manage the dynamics of difference, acquire and institutionalize cultural knowledge and adapt to diversity and the cultural contexts of the communities served. This also means an acknowledgement of health beliefs that vary by culture, Gavin said.
“African Americans can be vastly different, but we share some general and historical beliefs with varying levels of intensity,” Gavin said. “This includes a sometimes-distrust of the health care system and providers due to bad past experiences. There is a great tendency to see health care providers who look like us. Sometimes, there is a fatalistic view that defaults heavily to what God’s intension might be, and there can be behaviors that have the tendency to worsen chronic health conditions.”
Strategies for minority participation
In light of these nuances, trialists must go where the populations of interest are located, Gavin said. Leverage health professional societies, church networks, talk radio shows, historically black colleges and universities and Medicaid-managed care contact clients.
“These are the places where one has to develop effective recruitment networks,” Gavin said. “Using this kind of leverage of resources, we have secured patients for a number of trials for a broad mix of sponsors.”
There are other important elements to keep in mind, beginning with minimizing inconveniences, maintaining flexibility, and communication with respect, Gavin said.
“None of this works if there is not the perception of a relationship, where responsiveness is not forced,” Gavin said. “Actively listen. Ask how people want to be addressed. If they have a title — deacon, reverend — use it. This is a very important piece of the cultural competence machinery.”
Retention is vital
Providers must leverage communication to the fullest to keep study participants engaged and educated about the trial they are participating in, Gavin said. Use telehealth to text or email appointment reminders, develop private chat rooms between the participants and study coordinator, and provide ongoing educational workshops for participants.
“The more our subjects learn and understand about the disease state, the deeper their investment in the trial’s outcome,” Gavin said.
A site-specific retention action plan can help, which can include a commitment from the sponsor and site on goals, timelines and resources needed to support the plan, identify the resources needed, determine roles and responsibilities and document what is and is not working, Gavin said.
“It is very clear that this need and this mandate are as urgent as they ever have been,” Gavin said. “Cultural competence practices are necessary to encourage and retain minority participation. In order to be effective, ideas must be rendered practical, so you can leverage these various recruitment and retention opportunities among minority groups.”
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Gavin JR, et al. Increasing patient participation in research: Strategies for success. ENDO Online; June 8-19, 2020.
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