Moderna recently announced that 37 percent of trial participants are people of color. And Pfizer — which is conducting clinical vaccine trials in six countries, including in 39 states in the US — reports that 42 percent of overall participants and 30 percent of US-based participants in its trials are people of color.
The Food and Drug Administration’s focus on this and the companies’ recruitment success can, and should, serve as a guide for an industry that has long struggled to build trials that reflect the nation’s diversity and ensure that medications are safe and effective for all.
Just this week, the FDA published its latest guide to increase enrollment of patients of diverse backgrounds in clinical trials. In 2012, Congress passed a law requiring the FDA to collect diversity data on clinical trial patients. A few years later, the FDA started publishing reports with the aggregated demographic data, which show that diversity is improving very slowly. In 2015, only 5 percent of participants in clinical trials for novel drugs submitted to the FDA for approval in that year were Black, while 79 percent were white, according to a new report from the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. Last year, 9 percent of participants were Black, 72 percent were white, 9 percent were Asian, and 18 percent were reported as other.
There are glaring instances where failing to recruit people of color to clinical trials thwarts the ability to know if a treatment is effective for the patients it is meant to serve. Multiple myeloma, a type of blood cancer, disproportionately affects Black people: They represent 30 percent of multiple myeloma patients in the United States. And yet, of all individuals enrolled in clinical trials for multiple myeloma drugs submitted to the FDA between 2003 and 2017, only 4.5 percent of participants were Black, according to an FDA review.
Consider the following incident. The presidents of two historically Black universities in Louisiana wrote a joint letter in September to their campuses underscoring the “importance that a significant number of black and brown subjects participate” in Phase 3 vaccine trials “so that the effectiveness of these vaccines be understood across the many diverse populations that comprise these United States.” But it backfired, as angry reactions soon emerged on the universities’ social media accounts. “Stop pushing nonsense,” wrote a Black male on Instagram in response. “Don’t set our children up to be guinea pigs,” said a Black woman.
There are other barriers to enrolling people of color. Often, clinical trials require a time commitment that many people of color cannot make, since they are more likely to work in jobs that don’t provide flexibility. Translation is not often offered in these studies; therefore, non-English speakers may be excluded at a higher rate.
Per FDA guidance, all pharmaceutical companies are being encouraged to recruit diverse participants in their COVID-19 trials. Pfizer and Moderna’s success in recruiting diverse patients offers some lessons. Moderna reportedly slowed down recruitment in September to enroll more individuals from communities of color, and it was asking recruiters to enroll only Black and Latino individuals. It paid off: About 20 percent of those enrolled in Moderna’s Phase 3 vaccine trial (when the vaccine is administered to thousands of people and tested for safety and efficacy) are Latino, 10 percent are Black, and 4 percent are Asian, according to the company. Pfizer went international and launched clinical trial sites in Brazil, which helped strengthen its trial diversity figures, but it also signals that the manufacturer is eyeing a global market. Moderna’s numbers show that the United States has enough diversity to draw from.
It’s especially important to have this diversity because both Pfizer and Moderna’s COVID-19 vaccines draw on new methods that rely on messenger RNA; vaccines with this technology have yet to be taken by large populations. Both companies are testing their COVID-19 vaccines on a combined group of approximately 74,000 volunteers.
The biggest public health crisis in a century, the COVID-19 pandemic, has exposed the industry-wide obstacles to Black and brown patients participating in clinical trials like never before and has highlighted the urgency of tackling them. “I’ve never had a study where someone calls and says we need three more Hispanic patients today,” the CEO of a private company that runs clinical trials told Quartz. “And we’re having those kinds of calls now.”
Educating and engaging Black and brown communities early, before a clinical trial even begins, is key to building trust. Other proven recruiting strategies include allying with community groups like churches, engaging younger generations who could then bring their older peers along, and increasing the number of doctors of color at the trial sites.
Diversifying clinical trials is a little-noticed but important challenge for a country in the midst of a racial reckoning. Success with COVID-19 should be the start of a larger overhaul for the industry — and a healthier future for people of color.
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