Enrollment Of Black People In U.S. Clinical Trials Is A Challenge

By Julie Steenhuysen and Nick Brown

Fri. Jan 29, 2021 (Reuters) – Infectious disease doctor Angela Branche needed help.

Branche and colleagues at the University of Rochester Medical Center in New York were running a clinical trial for a vaccine against the coronavirus, which kills Black people at three times the rate it kills whites – yet it was mostly whites signing up. They needed more African Americans.

Unbeknownst to Branche, five miles away in Rochester’s poorest zip code, ordained minister Marsha Allen was planning a door-knocking campaign to educate residents of the mostly Black neighborhood about the virus that has killed more than 420,000 Americans.

Both women are Ivy League-educated and Black, but they exist in different orbits – one in the halls of science, the other in often-forgotten communities. Mutual connections brought them together, and in July, the pair formed an alliance: Branche’s team would help with COVID-19 education, and Allen would recruit Black participants for the vaccine trial – starting with herself.

“Doctors can’t come in here with their white suits and needles – no one will listen,” said Allen, leader of an organization called the Global Humanitarian Surround Care Mobile Wellness Initiative, whose work before the pandemic included outreach in Haiti. In Rochester, where Allen runs a community garden, she is known as Sister Marsha.

The blueprint Branche and Allen followed for the ongoing AstraZeneca Plc trial is becoming increasingly common across the United States for COVID-19 vaccine outreach. Often led by doctors and scientists of color, the efforts rely heavily on grassroots partners such as churches and health centers, and aim to topple long-standing barriers that keep minorities from participating in clinical trials.

The initiatives could change the way vaccine and drug trials are conducted in the United States, according to Reuters interviews with more than 40 public health and pharmaceutical-industry officials.

“This mindset about diversity – of not just being an afterthought but a central part of successful trials – is beginning to sink in,” Dr. Francis Collins, director of the U.S. National Institutes of Health (NIH), told Reuters.

Enrollment of Black people in clinical trials is a particular challenge. Mistrust runs high, in part because of the nation’s history of unethical practices in medical research on African Americans.

Melanie Campbell, who runs a Washington, D.C.-based nonprofit focused on Black civic participation nationwide, nearly died of COVID-19 last year, spending three weeks in intensive care. Although she sees the need to set an example, she still has reservations about the shot.

“I don’t know one (Black) person who isn’t afraid of this frigging vaccine,” she said.

Before now, Black people have accounted for an estimated 3% to 5% of enrollees in vaccine trials, although they make up about 13% of the U.S. population, researchers say. In COVID-19 vaccine trials, their participation so far is up to 10%, according to vaccine manufacturers.

Unless vaccines are thoroughly tested among Blacks, many will skip the shots, medical experts say.

That’s a problem because African Americans are more likely to contract the coronavirus. They more often live in crowded housing and work face-to-face with the public, raising the risk of infection. They also have higher rates of chronic conditions such as diabetes and less access to good medical care, factors which can complicate treatment and decrease odds of survival.

Branche said that’s a big reason why the NIH and pharmaceutical companies have essentially told researchers like her: Increase African American enrollment – or risk having your vaccination site shut down.

FROM THE TOP

It was July 4th, U.S. Independence Day. But it was no holiday for NIH director Collins. Clinical trials by vaccine makers Moderna Inc and Pfizer Inc were due to start soon, and Collins feared that minority recruitment would lag.

Collins said he hastily convened a conference call, summoning NIH officials and advisers involved in Operation Warp Speed, the government’s $12.4 billion program overseeing COVID-19 vaccine trials.

He and other call participants recalled his message as blunt. “It’s not just a nice idea,” Collins told Reuters. “It’s not just like, ‘Well, yeah, diversity is important.’ This is critical for the scientific credibility of these trials.”

The result was an NIH diversity initiative led in part by Dr. Gary Gibbons, a Black physician who heads the U.S. National Heart, Lung and Blood Institute (NHLBI).

The $12 million initiative finances research teams in 11 states that hold focus groups in minority communities to formulate vaccine messaging campaigns and promote trial participation. The effort also brings together the often-siloed institutes and centers within NIH that have established ties to communities of color.

Greg Millett, an AIDS researcher who sits on an exclusively African American scientific advisory board for coronavirus vaccine trials, likened the effort to early HIV prevention messaging in hard-hit Black communities. That and other public health campaigns have relied on community leaders, such as pastors and barbers.

The COVID-19 outreach efforts have helped to double the historic rate of participation by Black people in vaccine trials. Some researchers, however, say Blacks’ participation should exceed their share of the U.S. population, given the outsized impact of COVID-19 in this group.

Among the two companies with vaccines already on the U.S. market, Moderna Inc said 10% of U.S. trial volunteers were Black – a level reached only after the company slowed trial enrollment in September to improve African American participation. Pfizer Inc said its Black enrollment was 9%.

Moderna Chief Executive Officer Stephane Bancel told Reuters the company had closed some test sites where minority representation fell short. “If some important subpopulation has worries and questions about the safety and efficacy of the vaccine … we will not have succeeded,” Bancel said.

AstraZeneca said on Wednesday it had completed trial enrollment with 9.8% African American participation.

To meet its enrollment targets, Johnson & Johnson enrolled only minorities and elderly people in the final days of its U.S. trials, Chief Scientific Officer Paul Stoffels told Reuters. He did not provide statistics but said the company eventually met “all of our objectives” for minority enrollment.

“It took longer than we expected to get people comfortable with joining the study,” Stoffels said.

REASONS FOR SKEPTICISM

Boosting minority enrollment is complicated by historical mistrust, especially among Black people.

During the infamous Tuskegee Syphilis Study last century, government researchers left hundreds of Black men untreated for decades to study the disease’s debilitating and sometimes deadly effects. And in 1951, tissues taken without consent from a Black cancer patient in Baltimore were used to create a cell line used for myriad medical experiments – a well-known ethical breach.

Today, the mistrust extends to vetted COVID-19 vaccines, not to mention vaccine trials. A Reuters/Ipsos poll in December showed just 49% of Black Americans would be interested in being vaccinated, 14 points below whites’ level of interest.

Rochester resident Edwina Killings, 58, recently spoke to Reuters from a hospital bed, battling a severe case of COVID-19. Gasping for air, Killings recalled how, weeks earlier, Sister Marsha Allen had offered to enroll her in the Rochester trial. She declined.

“I wanted to see how it worked on other people first,” said Killings, who is back home but still on oxygen.

Focus groups led by the University of Kentucky’s Lovoria Williams found Black respondents skeptical partly because of the speed of coronavirus vaccine development. However, the focus groups showed that ads depicting researchers of color could help mitigate the mistrust, said Williams, co-director for special populations at the university’s Center for Clinical and Translational Science.

Williams, whose work is funded by NIH, shares her intel with community leaders like Michael Minor, a Baptist pastor and health advocate in DeSoto County, Mississippi. Minor made national headlines when he was honored by then-First Lady Michelle Obama in 2009 after banning fried chicken, which is high in fat, calories and salt, at church functions.

More recently, the pastor, whose county has the most COVID-19 cases in the state, sent his congregation text blasts with links to articles about the dangers of skipping vaccination.

Recruiting people to help test vaccines is a steeper challenge. Allen said success depends on including people like her, not just as messengers but as leaders every bit as important as researchers like Branche.

“It’s not like dropping food out of an airplane in a poor country,” Allen said. “You have to work to get people on board. What’s the point of investing in a vaccine if the people don’t want it?”

(Julie Steenhuysen reported from Chicago, Nick Brown from New York. Lindsay DeDario contributed reporting from Rochester, New York. Editing by Michele Gershberg and Julie Marquis)