As vaccines move into phase 3 trials, diversity must be at top of agenda

By: DR. LAITH ALEXANDER AND SONY SALZMAN, ABC News

(NEW YORK) — Ensuring Black and ethnic minority participation in coronavirus vaccine trials is key if we want a truly effective coronavirus vaccine, according to top epidemiology experts.

This past week, as two massive phase 3 trials slated to enroll 30,000 people each launched in the United States, researchers running those trials are working to ensure a significant portion of the people who volunteer hail from the communities that are hardest-hit by the pandemic.

“We know that there are higher mortality rates in Black and ethnic minority people and infections are being propagated at much higher in these groups,” Dr. Sam Oh, director of epidemiology for the University of California, San Francisco Asthma Collaboratory, told ABC News. “When we look at these communities, COVID-19 takes its toll on people with specific comorbidities. Is there something specific about these minority races that puts them at risk? We don’t know that yet.”

But here’s the issue: Historically, investigations into treatments, including vaccines, have not fairly represented people of Black and minority ethnic people.

“When you look deeper into it, medications were made for the average person,” said Oh. But when it comes to most research studies, “the average person is white, older and male.”

Doctors look at a files at the Respiratory & Meningeal Pathogens Research Unit at the Chris Hani Baragwanath Hospital in Soweto, South Africa, on July 14, 2020. Six senior clinicians in the Faculty of Health Sciences at Wits University have volunteered to participate in South Africas first COVID-19 vaccine trial.

Researchers have been worried that clinical trials investigating vaccines haven’t been diverse enough. It’s a problem because the effectiveness of vaccines can be influenced by many factors, including socioeconomic, genetic and environmental, with racial differences potentially affecting many of these.

There are concerns about treatment effectiveness if trials don’t include people from different ethnic backgrounds. These lessons have cropped up in medicine time and time again — tests and treatments that were developed in predominantly white people, that don’t work nearly as well in ethnic minorities or people with particular genetic variants.

There is a whole discipline called pharmacogenetics, which investigates how genetic factors might influence treatment effectiveness. While vaccines might be less affected than medications when it comes to genetic factors, it’s still possible that the immune responses generate to vaccines are subtly different.

If the vaccines aren’t tested in specific populations, there might also be issues with compliance if the vaccine does eventually get distributed to the general public. “If the vaccine is not tested in the groups that need it the most, I think there is less likelihood those groups will be accepting of it, because it wasn’t specifically shown to work in that population,” said Dr. Dan Barouch, William Bosworth Castle professor of medicine at Harvard Medical School.

“You really need the buy in from the community from the start,” Oh explained.

In addition, several clinical trials are partly funded by taxpayer money. “The U.S. taxpayer base is getting more and more diverse,” Oh told ABC News, “and as our taxpayer diversifies, that base is becoming increasingly underrepresented in the research they fund.”

“The vaccine needs to be tested in those that are highest risk, and ultimately needs to be accepted in groups that are in highest risk,” Barouch told ABC News.

It’s clear that engaging minority ethnicities in clinical trials is an important issue to address. But it has been a longstanding challenge with multiple underlying reasons.

“The reasons why biomedical studies are under representing minority population is partly in the design and execution of studies themselves, and also because of either preferences or characteristics of study subjects that you would like to bring in,” Oh said to ABC News.

“Looking at study design, if your study has eligibility criteria and you need to assess people, most assessments are Monday to Friday, 9 to 5. If you have time during the week to go to the study center to be evaluated, you are more likely to enter the study. If you are working a job or several jobs that don’t allow you to take time off, you can’t,” he explained.

From the perspective of study subjects, that has been a sad history of unethical experiments on ethnic minorities, the most infamous of which is the Tuskegee Syphilis Trial, where Black participants weren’t told that they had contracted syphilis and were not treated effectively for it.

“There’s a concern about mistrust of science and government,” Dr. Eliseo Perez-Stable, director of the National Institute on Minority Health and Health Disparities at the National Institutes of Health, told ABC News. “People don’t believe things coming from Washington, and the mistrust of science has been promoted by certain segments of leadership in the U.S. Minorities are also concerned if vaccine trials only have young white adults in the study sample — people won’t believe it’s safe in them, because it wasn’t tested in them.”

So, when drug companies and universities are looking for an answer to the coronavirus, how are they ensuring that their study populations are racially and ethnically diverse?

Part of the solution lies in the diversity of the researchers in universities and drug companies who are carrying out the trials.

“It’s important to have diversity in people with decision-making power. Companies have to actively recruit people into those positions; some executives may have to cede some of their own power and authority and give it over to other people,” Oh said. “Organizations can also partner with existing networks to increase the likelihood of getting more diversity in their recruitment.”

Of course, improving diversity don’t just happen overnight. Similarly, there is a lot of logistics that goes into recruitment — so dramatic changes in study populations can’t happen too quickly.

Progress is being made.

According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, there have been encouraging signs from the people who have pre-registered for the phase 3 trial conducted by the biotech company Moderna and the NIAID.

“I think, up to 15 or more thousand, who are pre-enrolled, of those 19% are African American and 19% are Latinx, which is really good news now because we want, we want to get that, and even more because of the disproportionate numbers, and seriousness among that demographic group,” Fauci said, speaking during an Instagram live interview with ABC News’ chief medical correspondent Dr. Jen Ashton.

“The topic of inclusion has been a long-standing effort in NIH,” Perez-Stable told ABC News. “The last data 40% of all participants in NIH-funded clinical trials were racial and ethnic minority groups as classified in the U.S. census.”

However, there is still a long way to go. “There has been an FDA requirement since 2017 that trials report the ethnic composition of the studies,” Perez-Stable said. “The drug companies still only had around 10% of their participants coming from ethnic minorities — they haven’t yet embraced diversity as their way of operating.”

Never has the pace of scientific research and clinical trials been so rapid and so intense. There are now lots of opportunities to get this right — and make sustainable, permanent change in how we design clinical trials to be more inclusive and diverse.

According to experts, lives depend on it.

Dr. Laith Alexander is an academic doctor at St. Thomas’ Hospital, London, working with ABC News Medical Unit. Sony Salzman is the unit’s coordinating producer.

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