Clinical trial diversity used to be seen “as kind of a ‘nice to have,’” said Gary A. Puckrein, Ph.D., President and CEO of the National Minority Quality Forum (NMQF), in an interview with Bio.News. “It was sort of an ethics conversation, if you will. But now, it’s a business conversation, because of the demographic shift.”
Clinical research and trials stand at the core of innovation and the development of drugs, vaccines, devices, and interventions. But the still-prevalent racial and ethnic disparities prove the need for a much-needed reform—sooner, rather than later.
“When you say clinical trials to us, we’re saying that’s part of preparing the marketplace for the changes that are occurring,” added Dr. Puckrein.
In addition to proving the safety of drugs for all populations, enhancing clinical diversity can build trust and promote fairness in science and biotechnology. During Black History Month, we look at why we have this problem and what the industry and other stakeholders and advocates are doing about it.
How we got here
It starts with trust—or the lack thereof.
Considered “the most infamous biomedical study in U.S. history,” the Untreated Syphilis Study at Tuskegee (USPHS) involved 600 African-American men, 399 of whom had syphilis, and 201 who did not. The unethical experiment began in 1932 in Tuskegee, Alabama and lasted until 1972, where hundreds of Black men “went untreated, given placebos and other ineffective treatments, so that scientists could study the effects of the disease, even after there was a cure,” explains Stanford University.
As clinical trial participation is voluntary, it becomes clear why diversity is an issue even almost a whole century later. Today, health systems are still perceived as “discriminatory” against those of lower socioeconomic status. According to the New England Journal of Medicine (NEJM), the mortality rate among Black men is higher due to this lack of trust in medical professionals, which ultimately results in reduced health care use.
“In 1965, the Civil Rights Act is the first time that, by law, African Americans could participate in the marketplace freely,” Dr. Puckrein explained. “What we see from 1965 to the present is African Americans working on what we call building sustainable, healthy communities. And healthcare is a critical part of that. And gaining access to advanced medicine is a critical part of that change.”
Pain from the past = distrust in the present
“Currently, African Americans only make up 15% of the minority participants in clinical trials,” the National Library of Medicine (NLM) reported.
A more recent example is COVID-19, which—especially in its earlier stages—disproportionately affected racial and ethnic minority groups. But in clinical trials for the Moderna vaccine, for example, only 7% of participants were Black, even though they are 13% of the U.S. population, a Harvard report said.
Similarly, the Federal Drug Administration’s (FDA) Drug Trials Snapshot of 2020 revealed that of 32,000 participants in clinical trials for drugs, only 8% were Black or African Americans, compared to 75% White participants.
Creating a safe space for a diverse population
Recruiting potential trial participants has to go beyond basic incentives, such as covering the cost of transportation and meals for the duration of the trial.
According to Ajay Singh, senior associate dean for postgraduate medical education at Harvard Medical School, step one to enhancing clinical trial diversity is to make clinical researchers aware that a diverse population in a trial goes beyond the regulatory aspect.
Step two, he says, is to build trust among the potential participants.
“Of course, the role of the ethics committee is important,” Singh explains. “They work towards making sure that a trial is safe and that any potential risks are explained in the consent form. However, the ethics committee also provides guardrails to the principal investigator in emphasizing the recruitment of a representative population. That said, community outreach shouldn’t be forgotten by the principal investigator as a means to build trust during the recruitment process.”
BIO remains committed to clinical trial diversity
Understanding the pressing need for clinical trial diversity—for both business and ethical reasons—BIO has long worked to help biotech companies improve clinical trial diversity. BIO launched the Clinical Trials: The Power of Participation (CTPoP) website to help people find information about clinical trials, and published a white paper, “Improving Diversity, Equity, and Inclusion in Clinical Trials.”
Both the website and white paper aim to find solutions, share resources, and push for more efforts to overcome the obstacles to clinical trial diversity, Bio.News previously reported.
“When clinical trials are diversified, everyone’s health improves,” said BIO’s Board Chair, Dr. Ted W. Love. “The culmination of the white paper and the guidance that will be available on the new CTPoP website will give patients the tools they need to get access to the clinical trials that might be the very thing they need to save their life.”
Additionally, BIO held a roundtable discussion in January last year focused on the development of action plans for data usage to enhance diversity in clinical trials.
“BIO is working hard to continue to advance our diversity agenda,” said BIO Chief Scientific Officer Dr. Cartier Esham.
BIO member Genentech has already made a step in the positive direction by implementing inclusive research practices in their early-stage clinical studies for drug development. The Genentech Research and Early Development (gRED) team has several studies underway that actively seek to increase participation by historically underrepresented patient groups, the company said.
“To ensure the study reflects the real-world population, the gRED study team has developed a plan to enroll diverse patients by using U.S. Census data to concentrate the clinical sites in the southern states in the U.S. and other diverse areas, thereby providing access to historically underrepresented communities and patients of low socioeconomic status,” Genentech explained.
