Academic journal

Only 43% of clinical trials report race, ethnicity

  • In a new study, researchers analyzed more than 20,000 clinical trials to determine whether they reported data on race or ethnicity.
  • The researchers also looked at whether the trial participants were representative of the US population.
  • The researchers found that more than half of the clinical trials did not report data on race or ethnicity, and 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 the effectiveness of therapies, often to the detriment of marginalized communities.

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

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

The researchers analyzed data from 20,692 US-based trials between the years 2000 and 2020, including unpublished trials.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

The researchers found that reporting of race and ethnicity data was poor. Although it has improved in 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 people who are marginalized based on their race or ethnicity continues to be poor, but shows signs of slowly improving. Only 43% of trials reported data on race or ethnicity.

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

The researchers found that Hispanics/Latinos and Asians were particularly underrepresented. Black enrollment was not below statistical representation in the US population – however, in approximately 21% of trials, no black participants were reported.

In contrast, whites were overrepresented compared to US 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 in the study.

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

– Dr. Barrett

“While funders may request this data in the form of projections in grant proposals, there remains minimal liability, meaningful follow-up, or consequences for studies that do not meet accumulation goals such as reviews or the requirements for developing a plan to achieve equitable and inclusive registration.”

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

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

“Research studies, such as the Tuskegee Syphilis Study, has caused unnecessary harm and deceit to minorities. Despite the establishment of institutional review boards, minorities are more likely to be skeptical of scientific research than non-Hispanic white people,” Dr. Zamora-Kapoor said.

Dr. Airín D. Martínez – assistant professor of health policy and management at the University of Massachusetts-Amherst – agreed, adding that there are also many other cases of historical biomedical exploitation of marginalized people. Dr. Martínez also did not participate in the study.

“Additionally, many people of color in the United States do not trust the health care system, not just because of this history, but because of the substandard care provided to non-white patients in the United States,” said Dr. Martínez. .

Dr. Martínez also said that researchers often do not specify why the inclusion of race or ethnicity data may be important in interpreting their results.

“Most scholars still conceptualize and operationalize race as a biological construct, whereas it is a political construct made to create difference and distribute rights, recognition, and resources to non-whites in formation and the continuation of the United States”

– Dr. Martinez

“Nevertheless, the consequences of racism produce material, psychosocial, physical and physiological effects that negatively affect the lives and health of racial and ethnic minorities.”

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

“Representation matters as much to scientists as it does to research participants. We – myself included – bring different perspectives to 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 senior and corresponding author of the new study. Talk to DTMhe said:

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

“Building a long-term relationship is essential here – participants who are already skeptical are unlikely to be appeased by night-flying in-and-out strategies.”

Another helpful strategy is to “use technology for outreach, including tools like automated text reminders and other technology platforms that make it easier to work with 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 – told DTM that taking a patient-centric approach to clinical trials can help change things for the better.

“Patient-centricity is fundamental, and decision-making around clinical trial development at the sponsor and investigator level must begin 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 improve the participation of underrepresented groups represented are less likely to be successful,” said Dr Dave.

Dr. Dave also added that diversity, equity and inclusion must be addressed in clinical trial applications and be central to 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.”

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

Dr Martinez

“Additionally, these applications should be evaluated on how well they include trusted community partners who can facilitate research design, participant recruitment, tracking, and retention,” Dr. Martínez said.

Dr. Turner echoes similar sentiments. “[D]collecting and reporting ata is the easiest [to fix]and frankly, if this were required by funding bodies and publishing bodies, the problem would be solved very quickly for the majority of trials.

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

For Dr Barrett, “it is essential that in addition to accountability, there is a need to provide training programs and resources to assist funded organisations, contract research organizations and industry research teams and academia to be effective in enrolling and retaining underrepresented racial and ethnic groups in research.”