Want more diversity in clinical trials? Start with the researchers

In the coming months, the selection of COVID vaccines is expected to be plentiful.

A total of 20 of the more than 60 vaccine candidates in development were in Phase 3 clinical trials as of Jan. 20, according to the World Health Organization. A number of those are likely to join the two currently in use and the most promising candidates from drugmakers like Johnson & Johnson and AstraZeneca that are only weeks away from gaining approval in the U.S.

But there’s one thing that’s missing.

Black patients represented 10% and Latinos 13% of participants in the Phase 3 clinical trial studies for the vaccine developed by Pfizer and BioNTech. Black patients also made up 10% of participants in the Moderna vaccine trial while Latinos accounted for 20%.

Those studies reflect the higher end of minority representation in coronavirus clinical trials. Trial data for the vaccine candidate being developed by Johnson & Johnson’s Janssen Pharmaceuticals found Black patients made up only 5% of all participants ages 55 and under while Latino patients accounted for 4%.

The low rate of Black and Latinos patients in the coronavirus vaccine studies underscores a long-standing problem: racial and ethnic minorities represent on average about 17% of participants in industry-sponsored clinical trials despite making up a third of the population.

While Black and Latino individuals are more than three times as likely to be hospitalized and more than twice as likely to die from COVID-19 as white patients, both groups were underrepresented in many of the vaccine clinical trials.

Several drug companies are investing in educational outreach programs to recruit more minorities trial enrollees.

But some think there’s another way to increase diversity.

“Creating a more diverse clinical research pool starts with a more diverse clinical research workforce,” said Jim Kremidas, executive director for the Association of Clinical Research Professionals. “We have to address the need for more clinical research professionals to keep up with the growing number of trials and ensure those trials are more representative of all our communities.”

Last November, ACRP expanded its digital campaign to attract racial and ethnic minority college students.

The association is encouraging minority high school juniors and seniors and college freshmen to search the organization’s website to learn about schools offering degrees in clinical research as well as information to help them get started in their careers with a list of training and internship programs.

A review conducted last year by ACRP examining workforce shortages in clinical research found that while the rate of studies had increased by about 12% over the past several years, the workforce had grown by only 9% annually over that period.

“For years and years we’ve heard that we don’t have enough investigators, we don’t have enough study coordinators, we don’t have enough site monitors,” Kremidas said.

While educational tools like webinars and outreach campaigns were important for recruitment, Kremidas said improving diversity among the more than 10,000 clinical trial investigators, coordinators, monitors and site managers who make up the clinical research workforce could attract more diverse populations to participate in important clinical studies like coronavirus vaccine trials.

Kremidas could not provide information on what share of clinical research professionals were minorities. But he contended the need for clinical research institutions to improve the diversity of their workforce was equally important to the efforts hospitals are taking to recruit more minority healthcare professionals as a way of providing care that is more culturally sensitive to a wider array of patients.

Experts contend that having a diverse population of clinical trial participants is critical to narrow racial health disparities by allowing developers to view the full range of risks and benefits of medical products. Yet a 2019 study conducted by the Tufts Center for the Study of Drug Development found that nearly 20% of all drug and biologic products approved by the Food and Drug Administration between 2007 and 2017 had missing data on the race of clinical trial participants and that half of drug approvals did not include information on the ethnicity of participants. The FDA does not require drugmakers to include women and minorities in their trials.

While efforts to increase diversity within the healthcare workforce have produced a variety of programs, such as mentoring and incentive initiatives for minority students to pursue careers in STEM fields, Kremidas acknowledged clinical research has lacked a similar focus in recruiting. Unlike working at a hospital, the public has largely lacked an understanding of the career opportunities that exist within clinical research.

It’s a problem that has largely been self-inflicted. Kremidas acknowledged that for many professionals, their careers in clinical research often began by chance.

“It’s very haphazard and serendipitous,” Kremidas said. “People don’t recognize clinical research as a career until they actually get into it or know someone who does it.”

For its part, the Pharmaceutical Research and Manufacturers of America recently flagged workforce diversity as part of a broader goal of improving clinical trial participant diversity when it released an updated version of its Principles on Conduct of Clinical Trial and Communication of Clinical Trial Results last October. The revised principles will take effect in April.

“A pool of diverse investigators can serve as a trusted and knowledgeable source of information for underrepresented diverse populations,” the document stated.

One of the companies that has committed to adhering to the new PhRMA principles is pharmaceutical giant Merck, which said in a statement the company was “… taking a strong stand on addressing the systemic issues that have deterred mainly Black and Brown communities particularly in the United States from participating in clinical trials, so that those who want to participate can participate.”

“We recognize that we have a responsibility to address the needs of an increasingly diverse set of patients, customers, employees and partners,” the company stated. “Since clinical trials function as the gatekeeper to bringing new medicines safely to patients and communities, nowhere is it more important that we have diverse representation than in our research efforts.”