- Researchers found that clinical trials conducted largely outside the United States were much less likely to enroll Black participants.
- On average, non-U.S. trials enrolled less than half the proportion of Black patients.
- Experts say that study researchers can take several steps to boost black enrollment participation in clinical trials by building trust levels in that community.
Spurred by lower costs, faster approval times, and less red tape, researchers have been moving a significant number of drug clinical trials overseas in recent years.
While this trend may be good for speed and the bottom line, it may be widening racial disparities in cancer clinical trials, according to a new study published online this month in Cancer, a peer-reviewed journal of the American Cancer Society.
The study was led by a team of researchers at the Icahn School of Medicine at Mount Sinai in New York City, including Matthew Galsky, a professor of medicine specializing in oncology and hematology, and Serena Tharakan, a third-year medical student.
For this retrospective study, researchers analyzed demographic information from 21 cancer trials that led to Food and Drug Administration (FDA) approvals between 2015 and 2018.
Researchers found that clinical trials conducted largely outside the United States were much less likely to enroll Black participants. On average, non-U.S. trials enrolled less than half the proportion of Black patients.
Of the 21 clinical trials supporting 18 FDA drug approvals where race and location data were available, 64 percent of patients were enrolled outside the United States, with Black patients accounting for an average of only 3.2 percent of trial participants, the study found.
Low participation rates of Black participants in clinical trials has long been an issue for researchers. A ProPublica report found that in 24 of 31 FDA cancer drug trials only about 5 percent of the participants were Black.
Experts attribute the low numbers to access and a lack of trust of the healthcare industry due to ongoing racial disparities in healthcare, systemic racism, and a track record of illegal and unethical experiments on Black people, such as the Tuskegee experiments where researchers deliberately back treating syphilis in Black men.
This new study raises concerns about the generalization of the efficacy of the drugs developed during these trials. Without more Black participants the authors question whether or not the findings about the efficacy and safety of cancer drugs will hold for people of color.
Expansion of trials for Investigational New Drug (IND) applications abroad “broadens the already existing gap in racial disparities in patient enrollment in cancer clinical trials,” said Gail Trauco, a registered nurse and clinical research consultant based in the Atlanta area.
She added that popular countries for expansion of U.S. INDs are Canada, Australia, Spain, the United Kingdom, and Israel — nations where the population is overwhelmingly white.
“The goal of a trial should be to inform about the efficacy of a drug,” said Tharakan, noting that generalization is important when doing trials or it might be difficult to speak to potential side effects for a subset of the population. “It might be applicable for a certain population but not the whole population.”
“Diversity within clinical trials is important for a number or reasons,” said Sanjeev Luther, president and CEO of Rafael Pharmaceuticals, an East Windsor, New Jersey-based company specializing in cancer therapies. “The findings can be skewed or non-encompassing of an entire population as a result of the lack of diversity, resulting in an incomplete understanding of drug safety and efficacy.”
He continued, “Diversity is important in studying cancer, orphan, and rare diseases because they are difficult to treat, but all conditions require the lens of inclusivity because they can affect all parts of our communities.”
Dr. Rajbir Singh, an internal medicine specialist and director of clinical and translational research at Meharry College of Medicine, a historically black medical school in Nashville, called the study groundbreaking.
“This is a good study. It hasn’t been done before,” he said, adding that more studies of this nature are needed and that future studies should consider looking at data from 2018 to 2020 as well.
Singh said researchers could take several steps to boost Black enrollment participation in clinical trials by building trust levels in that community. This could involve doing more to educate the community about ethical practices and safeguards in clinical trials, and advertising on social media platforms and television.
They can “educate people that trials are not conducted the same way as in the past and that the chances of a Tuskegee-like situation is zero and that trials are regularly monitored by the Food and Drug Administration and through IRBs.”
He said the healthcare industry should work at developing more Black physicians and researchers to help raise trust levels in that community. He said researchers should consider taking the trials to the community as part of the education process.
“There should be community advisory boards looking at how trials are presented to the community,” he said. “There should be patient stakeholder meetings talking how about how trials can help them and how they work.”
In addition, researchers should consider assisting black participants with transportation to trial sites as well as compensating them when they miss work.