Companies are working to develop new vaccines for COVID-19, and one of the many challenges is ensuring that clinical trials required to test the new medicines reflect the population at large in order to determine how effective the vaccines will be when offered to tens of millions of people throughout the United States.

In this Q&A, Lynne D. Richardson, MD, Professor and Vice Chair of Emergency Medicine, Professor of Population Health Science and Policy, and Co-Director of Mount Sinai’s Institute for Health Equity Research, talks about the latest COVID-19 vaccines, why it is important for clinical trials to include a diverse population, and how well the pharmaceutical industry has done that.

Based on data you have seen about the most advanced COVID-19 vaccines in development, do you think the pharmaceutical companies have done a good job including a diverse group of people in their clinical trials?

They are all committed to trying to include a diverse population into their trials. I think there have been substantial efforts to improve the diversity of the participants in the vaccine trials. From the data I’ve seen, I think they did an okay job, though ideally, the makeup of the folks in the trials would be the same as the distribution of the disease.

Why is it important to have a diverse group of people in the clinical trials for COVID-19 vaccines?

Trials are a way of getting information about how something works. So if you want to know that it works for people of all ages, people of all races, people of all ethnicities, people who have lots of other medical conditions, these people must be in the trial. This is always true, not just for vaccines. In addition, participation in the trials must be representative of the population that is suffering from whatever condition is being targeted by the vaccine, or the treatment. There are certain communities, specifically Black and Hispanic communities, who we know are being harder hit by COVID-19, both in the chance they contract COVID-19, and the severity of the disease if they do get it. That’s why it’s important to have a vaccine that is safe and effective for those communities.

Lynne D. Richardson, MD

In the past, how well have clinical trials included a diverse population, including people of color and those of different socio economic status?

If you go back 40 or 50 years, clinical trials consisted almost exclusively of white men between the ages of 25 and 65. They were considered the ideal subjects. The problem is, it is very hard to extrapolate the results and findings of the trial to types of people who are not participating in the trial. It was about 30 years ago that a big push to improve the gender diversity in clinical trials came with the establishment of an Office of Women’s Health at the National Institutes of Health, and that’s when the federal agencies that sponsored research started paying attention to who actually was participating in trials. It was about a decade later that significant attention to the racial and ethnic diversity in trial participation emerged. So it’s not a new issue. The degree of under-representation even a decade ago was staggering. About five percent of clinical trial participants were Black at a time when Black people accounted for 12 percent of the population. About one percent were Hispanic at a time when Hispanics were 16 percent of the population.

Why has ethnic and racial representation been so poor?

For patients, there is a legacy of mistrust of research, certainly among the African American population, but also mistrust of the health care system in general and of research, specifically among many disadvantaged populations. They are skeptical about the motives and intent of researchers. Also, there are access issues. Most clinical trial participants are recruited through their physicians, and often companies did not include physicians and practices that serve diverse patient populations.

What can be done about that?

Project Impact of the National Medical Association, a national association of Black physicians, has been working to diversify participation in clinical trials for more than a decade by speaking with Black physicians, who often have a group of patients that is much more diverse. They have published results that show that when Black people are approached in the same way, when they are encouraged to participate by a physician with whom they have a relationship, and whom they trust, they participate at the same rates as other groups. But you have to reach out to the physician and the physician practices, where they have those sorts of relationships.

How has the situation changed during the pandemic?

In the era of the COVID-19 pandemic, with Black people and Hispanics being disproportionately impacted by the virus, it’s essential to engage them in vaccine trials. Yet the level of public distrust in the research process and government has never been higher. So we have a lot of work to do if we’re going to get this pandemic under control.  Building trust means developing relationships and that takes time. This is an ongoing challenge in some of the trials and is why Mount Sinai has been approached by many of the pharmaceutical companies because we do have access to this diverse population.

What is Mount Sinai doing?

At the Mount Sinai Institute for Health Equity Research, we have been approached by various entities, asking us to help recruit more diverse populations into their studies. We start by talking about the things you have to do. First, you have to talk with some of our community partners and you have to accept their input, such as the language you use in the materials you distribute to participants. You need to look at how burdensome the trial will be. If we are going to combat mistrust, we must behave in a trustworthy manner.  The Institute is ready to work with researchers who are serious about building the relationships needed to recruit diverse populations into clinical trials.

WillieBenjamin Loadholt, right, undergoes a checkup from Kiwan Stewart, RN, at The Mount Sinai Hospital prior to receiving his second injection as a participant in the phase 3 clinical trial for Pfizer’s COVID-19 vaccine.

Participating in the Mount Sinai Health System’s clinical trial for the Pfizer COVID-19 vaccine has been deeply personal for New York City educator WillieBenjamin Loadholt. He says it has provided him with the opportunity to be proactive, to contribute to a potential solution that could put an end to the COVID-19 pandemic, which has been “devastating to the African American community.”

For months, Mr. Loadholt says, “Every time I would go on a friend’s Facebook page I would see, ‘We regret to announce the passing or the transition of this person or that person.’ A friend of mine owns a funeral home and they were doing so many funerals. This one’s mom passed away, or this one’s father or sister passed away. It was heartbreaking.”

So, in August, when a friend told him about the Pfizer COVID-19 vaccine trial at Mount Sinai, Mr. Loadholt was eager to sign up. “We want to know what’s going on,” he says. “People perish from a lack of knowledge. How can we avoid this? How can we get solutions for this?” Participating in the search for answers to the COVID-19 pandemic is “worthwhile because I am able to help myself as well as my community. We can’t get this if we don’t help each other.”

Mount Sinai is actively recruiting volunteer participants in communities of color. “We want to make sure the trial is representative of the people who were hardest hit by COVID-19,” says Debbie Lucy, Program Manager for the Mount Sinai Health System’s COVID Clinical Trials Unit. Based on a legacy of mistreatment and longstanding inequities in access to health care, Black Americans, in particular, are more hesitant than other groups to embrace the use of experimental vaccines and therapies.

Debbie Lucy

In August, Ms. Lucy and her team began handing out information about the vaccine in the communities around The Mount Sinai Hospital, between 96th and 105th Streets, east of Park Avenue. In fact, Mr. Loadholt found out about the clinical trial from a friend who lives in the area and received a knock on his door from Mount Sinai.

“We have teams of people who are out in different areas trying to educate people and get them involved. We are talking to people, handing out flyers, and making as many connections as we can,” says Ms. Lucy. “We’re going to different grocery stores, hair salons, nail salons, laundromats, restaurants—any place where we think people of color are either working or going to.”

When Ms. Lucy met a man who told her that his family did not have any masks, she says she called up a team member who immediately brought several masks to the corner of East 103rd Street where they were standing. “He was in awe that we went the extra mile to do that for him,” Ms. Lucy says. “For him it was more than the masks we gave him; it was the fact that we connected with him and met his need immediately. We stood out there and talked with him and gave him additional information about participating in the trial.”

Mount Sinai has also held community forums that educate people of color about the Pfizer vaccine trial. In September, Mr. Loadholt discussed his experience at one of these forums. Ms. Lucy says, “We believe it’s easier for people who look like you to talk with you about participating in a trial because we recognize that there’s a lot of mistrust around research among people of color. Our ultimate goal is to find a vaccine that’s going to help prevent COVID-19, but with any trial we also want to test for safety to make sure it’s not causing any negative side effects in people, and that it’s well tolerated.”

Of the more than 180 COVID-19 vaccines under development, Pfizer’s RNA vaccine is one of the furthest along in the phase 3 clinical trials taking place at Mount Sinai and other locations throughout the United States. The vaccine is based on new technology and can be produced completely in vitro, or in a laboratory.

“I am grateful to individuals like Mr. Loadholt who are participating in this vaccine study and helping us to inform others,” says Judith A. Aberg, MD, the Dr. George Baehr Professor of Clinical Medicine, and Chief of Infectious Diseases for the Mount Sinai Health System. “Involvement with communities should not be overlooked due to false assumptions that people of color are unwilling to enroll in clinical trials. Such false assumptions result in harmful health disparities. We must provide everyone with the opportunity to participate in clinical trials and receive linkage to care. Only through engagement and education can people protect themselves and their loved ones.”

After receiving his second of two injections in September, Mr. Loadholt says he feels fine. He does not know whether he received the real vaccine or a placebo, which is how the placebo-controlled, randomized, observer-blinded vaccine trial is designed. He will be able to find this out in two years. “If I did receive a placebo, at least I can help another person of color receive the real one,” he says.

Mount Sinai has provided Mr. Loadholt and other trial participants with either an iPhone app or their own separate device to communicate any symptoms. “The staff at Mount Sinai has been wonderful,” Mr. Loadholt adds. “I would like Mount Sinai to do what they’re doing and be a beacon in the community.”

To potential volunteers, he says, “Don’t be afraid. Try it.”