December 7, 2022

Filipino Guardian

Sentinels of Filipino Free Press

Why diversity is important in clinical trials

5 min read

In harming people of color and women more than other groups, the Covid-19 pandemic has brought to light a grim reality: Factors such as gender, race, and income can affect access to healthcare, disease rates, overall health, and even severely affect life expectancy.

A key to reducing such health disparities is to ensure that different groups of people are involved in clinical research. Understanding the impact of treatments on different populations is necessary to ensure everyone has access to quality, safe, and effective treatments.

A Brief History of Diversity in Clinical Trials

In the 1960s and 1970s, the Food and Drug Administration (FDA) recommended excluding women of childbearing potential from drug trials to avoid potential harm. The directive extended to women who were not pregnant or were not even likely to become pregnant. As a result, there was little data on how drugs affected women in general.

In the 1990s, Congress passed legislation requiring NIH-funded research to include women and members of underrepresented groups. The guidelines resulted in major advances: According to the FDA, more than half (56%) of the study participants for new drugs approved in 2020 were women. Three quarters were White, 11% Hispanic, 8% Black, and 6% Asian. But more work needs to be done.

“While there has been a concerted effort and recognition of the need for diversity in clinical trials, we still lack it,” said Phyllis E. Greenberger, Senior Vice President of Science and Health Policy at HealthyWomen and a longtime advocate for women’s inclusion in clinical trials.

Even when studies include women and people of color, differences between groups are not always analyzed and the number of non-white, non-male participants is not always large enough to know whether differences are real or clinically relevant.

“It’s not a perfect system; Studies are still being conducted that are not as diverse as we would like,” said Wendy Nembhard, Ph.D., MPH, FACE, professor and chair of the Division of Epidemiology at the Fay W. Boozman College of Public Health; director of the Arkansas Center for Birth Defects Research and Prevention; and Professor in the Department of Pediatrics at the University of Arkansas for Medical Sciences College of Medicine. “But the issue is on the table and efforts are being made to address it… Investigators can no longer remain silent on this issue.”

Progress may be on the horizon

Two influential organizations recently pledged to prioritize diversity. In April 2021, Pharmaceutical Research and Manufacturers of America (Phrma), a pharmaceutical industry advocacy group, introduced new policies for conducting clinical research, including a requirement to ensure diverse representation in clinical trials. And on January 1, 2022, the New England Journal of Medicine, a leading medical journal, required authors to submit data on the sex, race or ethnicity, age, and geography of their study participants.

The importance of diversity

Diversity in clinical trials is not just an ethical issue; it is also practical. Without involving people of all genders and races in the research, scientists cannot know for sure how different groups will respond to treatment, leaving healthcare providers uncertain about how best to treat particular patients.

“We know there are ethnic and gender differences,” Greenberger said. “If therapies and devices are to work differently in different populations, they need to be studied in those populations before they are prescribed.”

According to Nembhard, a lack of diversity in research can hide differences in side effects or undesirable effects. These gaps are particularly important in certain diseases, such as B. Preterm births, which are known to affect black women more often than non-Hispanic white women.

Another glaring gap in participation in clinical research is among pregnant women. Studying pregnant women is particularly sensitive because the researchers are asking women to potentially put themselves and their unborn child at risk, according to Nembhard.

“Pregnant women are reluctant to participate in clinical trials with unknown or limited effects on the fetus or themselves[selves] during pregnancy, no matter how noble the scientific cause — which is understandable,” she said. “The burden of living with that guilt is unimaginable.”

But, she said, getting more pregnant women involved in clinical trials is crucial.

“We really don’t have accurate information about how medications and interventions affect pregnant women or what the potential side effects are,” Nembhard said. “Much of what we know comes from animal models, post-postpartum pregnancy registry reports, or suspected effects.”

Obstacles in recruiting various participants

There are many barriers to recruiting women and non-white participants for clinical trials. At the top of the list is the distrust of certain populations towards biomedical research.

“Unfortunately, the story of unethical behavior is opposite [underrepresented people] in biomedical research is still fresh in people’s minds,” said Nembhard.

She cited the Tuskegee Syphilis Study, in which researchers studied black men with syphilis without offering them a known treatment (penicillin) — without their consent. This study did not end until 1972, when an advisory panel concluded that it was unethical.

Nembhard also pointed out barriers such as language, cultural competence and limited financial and human resources. Many studies include questionnaires that have only been validated in English or in predominantly white populations. Ensuring that questionnaires are culturally appropriate and translating surveys into multiple languages ​​can be difficult and expensive, as can hiring multilingual staff who can manage study protocols in different languages.

What needs to be done

Addressing very different barriers to diversifying participation requires very different solutions. For example, Greenberger said telemedicine is being considered for clinical trials whenever possible.

“Studies looking at common barriers to participation, such as transportation, childcare, and clinic hours, see an increase in minority participation,” Nembhard said.

Addressing distrust is a trickier problem, but Nembhard also sees opportunities there.

“Partnering with communities of color in designing research studies or in conducting the study has proven very successful in increasing minority participation in research studies in general, including clinical trials,” she said.

Additionally, Nembhard said that focus groups and community panels, which convene community leaders to act as advisors to the research team, can be effective in guiding research design to address the concerns of specific communities.

“Many researchers have worked hard to build trust within communities and collaborate with community members to conduct research that benefits community members and the world of science,” she said.

This resource was created with the support of Covis.

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