Minority representation in clinical trial studies for vaccines is important to ensure the vaccine protects all populations, but the medical community must work on rebuilding trust with minority communities, said Shobha Swaminathan, associate professor of medicine at Rutgers New Jersey Medical School (NJMS) and the medical director of the Infectious Diseases Practice at University Hospital in Newark.
Swaminathan, who is the principal investigator for the Moderna vaccine trial at NJMS, said some minority communities have been disproportionately impacted by the coronavirus disease (COVID-19) pandemic with regard to higher rates of mortality.
“Therefore, when it comes to the conduct of COVID-19 vaccine studies, it is critical to ensure that any approved vaccine is evaluated in a systematic manner to assure its safety and efficacy in all populations but especially those most impacted by the COVID-19 pandemic,” Swaminathan said.
The Moderna trial’s vaccine candidate for COVID-19 is mRNA-1273. Unlike a typical vaccine, which is made from a weakened or inactivated virus, mRNA-1273 is made from messenger ribonucleic acid (mRNA), which can help the body’s immune system create antibodies to fight the virus, according to the Moderna website.
Swaminathan said Moderna is hosting clinical trials at approximately 100 different sites across the U.S., but communities of color have been hesitant to participate in clinical trials. She said these communities have suffered from past incidents in medicine, citing the Tuskegee syphilis experiment or the case of Henrietta Lacks, who had her cells collected without her consent.
“There is data supporting that persons of color do not always get the same care as their white counterparts. Therefore, these communities have been traumatized to a significant degree and are ... hesitant to trust a clinical trial easily,” Swaminathan said.
Building trust and promoting engagement between the medical community and minority communities is an ongoing, evolving process, she said.
“It starts with active listening on the part of the researchers because if we listen carefully, the community will tell us what they need and want from us,” Swaminathan said.
Another way of rebuilding trust between the medical community and minority groups is participatory research, meaning the community is engaged throughout the clinical trial process, she said. This begins with the basic design of the study, where Swaminathan said researchers should incorporate community input regarding engagement and educate them about the study.
The informed consent process provides participants with information regarding potential risks or side effects of a trial and allows potential participants to ask questions about the process, according to the National Institutes of Health. Additionally, participants are allowed to leave trials for any reason and at any time.
“Participation in clinical studies is completely optional,” Swaminathan said. “It starts with a detailed, informed consent that provides an overview of (the) study, the risks and benefits of the intervention and emphasizes the voluntary nature of the study.”
Swaminathan said there are also multiple safety checks in place for clinical trials, including a study monitoring committee to review safety data, a local institutional review board with community representation and an independent safety monitoring board that reviews data to ensure the study adheres to clinical and ethical standards.
The ultimate benefit of adequately representing minority groups in clinical trials, Swaminathan said, is that the vaccine candidates being examined will have safety and efficacy data based on a diverse population, representative of the total U.S. population.
“When (a vaccine) is approved, we can state conclusively that the vaccine is safe and effective across all racial, ethnic and age groups,” she said.