Diversity emerges as key challenge for coronavirus drug trials


The coronavirus pandemic has hit disproportionately hard in Black and Hispanic communities, where infection rates and death rates have reached staggering levels. 

But as scientists race to develop vaccines against the SARS-CoV-2 virus and treatments for the COVID-19 disease it causes, many trials are struggling to enroll people from those very communities.

Government and private sector scientists trying to enroll tens of thousands of Americans in a handful of studies of potential coronavirus vaccines are working overtime to reach out to underrepresented communities. But they have reported running up against rumors and misinformation in minority communities in places like Seattle and New York City, where mistrust remains deeply rooted. 

That mistrust comes from America’s long history of discrimination against minority groups, some of whom have been used as human guinea pigs for sadistic experiments.  

The U.S. Public Health Service denied treatment to 600 Black men who had syphilis, even after penicillin became a widely available treatment, in the gruesome Tuskegee experiments. Native Americans were forced to undergo sterilization procedures, and some were used to test dangerous new pharmaceuticals. 

To many, that history is all too recent. Surveys conducted by the Pew Research Center and the Robert Wood Johnson Foundation in recent years have found both Black Americans and Native Americans are less trusting of medical doctors than are whites. 

“There are countless examples that all get pushed into a general well-founded feeling that when people are coming to do experiments or trials in Black communities, maybe there’s an ulterior motive,” said Prabhjot Singh, a health systems expert at the Arnold Institute of Global Health.

Enrolling a diverse set of patients and volunteers in trials is both a scientific and cultural imperative, said some of those involved in designing trials today.  

On the scientific side, so little is known about the way the coronavirus attacks the body and the way COVID-19 manifests that diversity — in age groups, ethnic groups and even socioeconomic status — is necessary to learn who is at risk of serious or severe symptoms. 

Some diseases strike certain ethnic groups more than others. People of African descent, Hispanic descent and Middle Eastern descent are more likely to be impacted by sickle cell disease. Some cardiovascular drugs are less effective in people of Asian descent than in those of European origin. 

Studies that include a diverse range of people can identify whether a vaccine would have different safety and efficacy profiles among different racial or ethnic groups. The goal, scientists said, is to develop treatments that work for everyone, even if that means different groups respond better to one treatment over another. 

“Having a clear representation of different minorities in these trials, you can ensure a vaccine is working across populations,” said Alejandro Cané, head of Vaccines Medical and Scientific Affairs at Pfizer. 

On the cultural side, enrolling a diverse range of people during the trial phase can lead to a broader acceptance once a vaccine or treatment is approved and becomes widely used.

“There is an element in which as we move to conquer COVID-19, not only is it important that we test and define the safety and efficacy in the case of vaccines in a broad and inclusive population of participants that reflects the diversity of our county, but will also we believe promote a sense of understanding, form an understanding of its protective benefit that we hope will translate into greater acceptance,” said Gary Gibbons, the director of the National Heart, Lung and Blood Institute at the National Institutes of Health (NIH). ”Any hesitancy is diminished because it is broadly reflective of people who work in the same sort of industries as I do, have the same sort of exposures, look like me and my neighborhood.”

Earlier this year, NIH launched a Community Engagement Alliance Against COVID-19 Disparities, a group Gibbons co-chairs, to create relationships with local leaders who can bridge the trust gap.

Pharmaceutical companies working on their own vaccines are creating new materials directed especially at minority groups. As part of its campaign to enroll more minority groups, NIH has held town hall meetings with representatives from the National Urban League, presidents of medical schools run by historically Black colleges, and faith-based community leaders. 

Pfizer has printed recruitment material in different languages, including Chinese, to bolster Asian American participation in its U.S. trial. The company is working with non-governmental and community groups to build trust, and it is targeting five states — Arizona, Florida, New York, North Carolina and Texas — that have higher-than-average Hispanic populations.

“In makes no sense to develop a vaccine in record time if at the end of the day people are not accepting the vaccine or using the vaccine,” Cané said in an interview. 

A spokesman for AstraZeneca, which is conducting phase three studies on its candidate, said the company was specifically targeting African American, Native American and Hispanic communities. AstraZeneca is also testing its vaccine in Brazil and South Africa. 

Some health systems enrolling patients in a trial of Moderna’s vaccine candidate are setting specific goals for minority participation. The University of Colorado School of Medicine aims to make minority communities 30 to 40 percent of its sample, it said in a press release. 

Gibbons said the outreach efforts are not solely aimed at minority communities. A growing faction of vaccine skeptics, both liberal and conservative, need to be convinced that the trials underway now will lead to effective vaccines in the long run. 

“There are issues that are broadly there about vaccination, and a lot of it still will build upon those same principles of helping people understand what a vaccine is, what we do know about its safety, and why it’s important not only to protect your family but your neighbors and your community,” Gibbons said in an interview. 

The race to find and recruit volunteers in minority communities is all the more urgent, experts say, because the coronavirus has so deeply impacted those very minorities. In almost every state that reports virus data by race and ethnicity, Black and Hispanic people make up a disproportionate share of both cases and deaths. 

In Washington, D.C., where 47 percent of the population is Black, three quarters of those who have died of the virus are Black. In Hawaii, just 10 percent of residents are Native Hawaiian or Pacific Islanders, but they represent 41 percent of all cases and 27 percent of all deaths. Twenty-nine percent of Marylanders are Black, but they make up 41 percent of all coronavirus-linked deaths. 

“The underrepresented populations, minorities like African American, Hispanics, Asians or Native Americans, are suffering in disproportionate ways the consequences of the pandemic,” Cané said. “They are suffering more disease, more severe disease.”

Source Article