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New research finds that over half of clinical trials do not report race and ethnicity data. SDI Productions/Getty Images
  • In a new study, researchers have analyzed over 20,000 clinical trials to determine if they reported data on race or ethnicity.
  • The researchers also looked at whether the participants in the trials were representative of the United States population.
  • The researchers found that over half of the clinical trials did not report race or ethnicity data, and that the trial participants recruited were generally not representative.

Clinical trials are used to determine if new therapies are safe and effective. However, if clinical trials are not diverse they may not be able to accurately predict how well the therapies will work — often to the detriment of marginalized communities.

A new study demonstrates that much more work needs to be done to ensure that the reporting and representation of race and ethnicity is equitable in clinical trials.

The study appears in the journal Lancet Regional Health —The Americas.

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The researchers analyzed data from 20,692 trials based in the U.S. between the years 2000 and 2020, including unpublished trials. These trials represented approximately 4.7 million participants.

The researchers found that the reporting of race and ethnicity data has been poor. While it has improved over recent years, the researchers describe this as a “low bar” given the low levels of reporting to begin with.

Likewise, the researchers found that the representation of marginalized people based on their race or ethnicity continues to be poor, but does show some signs of slow improvement. Only 43% of the trials reported data on race or ethnicity.

Where data were reported, the researchers found that marginalized groups taken as a whole — including, for the researchers, Black people, Hispanic/Latino people, Asian people, American Indian people, and “Other/Multi” — were underrepresented.

The researchers found that Hispanic/Latino and Asian people were particularly underrepresented. The enrollment of Black people was not below the statistical representation in the U.S. population — however, in approximately 21% of the trials no Black participants were reported.

In contrast, white people were overrepresented compared with the U.S. census information.

Medical News Today spoke with Dr. Nadine J. Barrett, Director of the Center for Equity in Research at the Duke Clinical Translational Science Institute. Dr. Barrett was not involved with the study.

“Historically, prioritizing diverse race and ethnic enrollment and retention in clinical trials has been dismal, and as noted in this landmark study, it continues with only 43% of studies reporting race and ethnicity data.”

– Dr. Barrett

“Although funders may request these data as projections within grant proposals, there remains minimal accountability, meaningful follow-up, or consequences for studies that do not meet accrual goals such as reviews or requirements to develop a plan to achieve equitable and inclusive enrollment.”

“These issues have a significant impact, particularly when in many cases underrepresented race and ethnic groups who are carrying the greatest burden of disease are not represented in clinical trials, contributing further to health disparities and inequities,” said Dr. Barrett.

According to Dr. Anna Zamora-Kapoor — community liaison for the Health Equity Research Center at Washington State University — a key factor that affects poor reporting and representation is historic unethical research practices. Dr. Zamora-Kapoor was not involved in the study.

“Research studies, such as the Tuskegee Syphilis Study, caused unnecessary harm and deception among minorities. Despite the creation of Institutional Review Boards, minorities are more likely to be skeptical of scientific research than non-Hispanic Whites,” said Dr. Zamora-Kapoor.

Dr. Airín D. Martínez — assistant professor in Health Policy & Management at the University of Massachusetts-Amherst — agreed, adding that there were also many other instances of historic biomedical exploitation of marginalized people. Dr. Martínez was also not involved in the study.

“Moreover, many People of Color in the U.S. do not trust the healthcare system, not solely resulting from this history, but as a result of the lower quality of care given to non-white patients in the United States,” said Dr. Martínez.

Dr. Martínez also said that often, researchers do not make clear why including data on race or ethnicity may be important for interpreting their findings.

“Most researchers still conceptualize and operationalize race as a biological construct, when it is a political construct made to create difference and distribute rights, recognition, and resources away from non-white people in the formation and continuation of the U.S.”

– Dr. Martínez

“Nonetheless, the consequences of racism produce material, psychosocial, physical, and physiological effects that adversely affect racial and ethnic minorities’ life and health outcomes.”

Dr. Martínez also highlighted a lack of principal investigators in clinical trials from marginalized racial or ethnic groups as a factor.

“Representation matters on the side of scientists as much as that of the research participants. We — including me — bring different perspectives to the research informed by both our scientific training and our lived experiences,” said Dr. Martínez.

Dr. Brandon E. Turner, radiation oncology resident at Massachusetts General Hospital/Brigham and Women’s Hospital in Boston, MA, is the lead and corresponding author of the new study. Speaking to MNT, he said:

“When trust is part of the issue, focusing on partnering with organizations to help build that trust can be effective (for example, some researchers are working with local church groups).”

“The establishment of a long-term relationship is key here — participants who are already skeptical will likely not be mollified by fly-by-night strategies that drop in and out.”

Another helpful strategy is “to use technology for outreach, including tools like automated text-reminders and other tech platforms that ease the work of inclusion.”

Dr. Gaurav Dave — associate professor, Division of General Medicine and Clinical Epidemiology at the University of North Carolina at Chapel Hill School of Medicine, who was not involved in the study — said to MNT that adopting a patient-centric approach in clinical trials may help change things for the better.

“Patient-centricity is foundational, and decision-making regarding clinical trial development at the sponsor and investigator levels should start by contextualizing diversity, inclusion, and equity in their practice.”

“Without the direct engagement of underrepresented communities as advisors or advocates during the trial development process, particularly the creation of recruitment and retention plans, efforts to enhance the participation of underrepresented groups are less likely to succeed,” said Dr. Dave.

Dr. Dave also added that diversity, equity, and inclusion must be addressed in clinical trial applications, and be made central to the funding offered by federal agencies.

Dr. Martínez agreed. “It would be ideal to have government agencies that fund or evaluate clinical trials to ensure diverse representation.”

“There should also be priority given to National Institutes of Health or U.S. Food and Drug Administration applications that would test a drug, intervention, or technology that addresses a health disparity in a historically marginalized racial and ethnic group.”

Dr. Martínez

“Moreover, these applications should be evaluated by how they include trustworthy community partners who can facilitate the research design, recruitment, follow-up, and retention of participants,” said Dr. Martínez.

Dr. Turner echoes similar sentiments. “[D]ata collection and reporting are the easiest [to fix], and frankly, if it was required by funding bodies and publishing organizations, the problem would be solved very rapidly for the majority of trials.”

“An example precedent for this was the move in 2005 by the ICMJE (International Committee of Medical Journal Editors) that required the registration of trials in a clinical trial repository in order to be considered for publication,” Dr. Turner added.

For Dr. Barrett, “it is critical that alongside accountability is the need to provide training programs and resources to support funded organizations, contract research organizations, and research teams in industry and academia to be effective in enrolling and retaining underrepresented racial and ethnic groups in research.”