By targeting people of color and women more severely than other groups, the Covid-19 pandemic exposed an unfortunate reality: gender, race and income can play an enormous role in access to healthcare, disease rates, overall health outcomes and life expectancies.
Key to addressing health disparities lies in including diverse groups in clinical research studies. Understanding the impacts of treatments across populations is necessary for providing access to high-quality, safe, and effective treatments for all.
Brief History of Diversity in Clinical Trials From the 1960s and ’70s on, the Food and Drug Administration (FDA) strongly advised against conducting drug trials with women of childbearing age to protect them from potential harm; this policy extended even to women who weren’t pregnant or likely to become pregnant; consequently there was little data collected on how certain drugs affected female subjects overall.
Congress passed legislation in the 90s mandating that research funded by NIH include women and underrepresented groups. These policies led to major progress: according to FDA estimates, over half (56%) of participants in trials for new drugs approved in 2020 were women; three-quarters were white while 11% of Hispanic participants, 8% Black participants, and 6% Asian individuals participated. More work still needs to be done.
“Despite efforts and recognition of the need for diversity in clinical trials, diversity remains under-recognized,” noted Phyllis E. Greenberger, HealthyWomen’s senior vice president for science and health policy, who has long advocated for women to participate in trials.
Even when studies include women and people of color, differences among groups aren’t always assessed; as well as enough non-white female participants to know if any differences exist and are clinically meaningful.
“Our current system isn’t perfect; studies still conduct without as many diversity measures,” stated Wendy Nembhard, Ph.D., MPH, FACE; professor and chair of Epidemiology at Fay W. Boozman College of Public Health; director of Arkansas Center for Birth Defects Research and Prevention; and professor in Pediatrics Department at University of Arkansas Medical Sciences College of Medicine. However, efforts have been put forth to address it… investigators must no longer remain silent when discussing such matters.
Progress may be on the horizon Two influential organizations have recently made commitments to prioritize diversity. In April 2021, Pharmaceutical Research and Manufacturers of America (Phrma), which represents the pharmaceutical industry, introduced new principles for conducting clinical research that included ensuring diverse representation in clinical trials. And on January 1, 2022, The New England Journal of Medicine began mandating that authors submit data on gender, race or ethnicity, age and location of participants.
Diversity in clinical trials is both ethically and practically imperative. Without including people of various genders and races in research, scientists simply don’t know for certain how different groups will respond to treatment and could leave healthcare providers clueless on how best to care for certain patients.
“We recognize there are ethnic and sex disparities,” Greenberger stated, “but if therapies or devices will work differently among different populations, then they need to be studied before being prescribed.
According to Nembhard, lack of diversity in research can mask differences in side effects or adverse reactions between patients of color and non-Hispanic white women when it comes to preterm birth rates. Such gaps become particularly crucial in conditions like preterm birth where rates among these groups tend to be significantly higher than for non-Hispanic white women.
One area in which clinical research participation stands out for pregnant women is research, according to Nembhard. Investigating pregnant women can be especially delicate because doing so places both mother and unborn baby at risk.
“Pregnant women often eschew clinical trials that may have unknown or limited effects on them or their unborn fetuses during gestation, no matter the noble scientific cause – this is understandable,” according to Prof. Killian. “Living with guilt can be unbearable.”
She noted the significance of including more pregnant women in clinical trials is essential.
Nembhard acknowledged, however, that an accurate understanding of how medications and interventions affect pregnant women or the potential side effects is lacking. Most information available to us comes from animal models or reports from pregnancy registries after the fact. Hypothesized effects also make up part of this body of knowledge.
Obstacles to Recruitment of Diverse Participants
Recruitment of women and non-white participants into clinical trials has many obstacles, chief among them a widespread distrust for biomedical research among certain communities.
“Sadly, memories of unethical behavior toward [underrepresented groups] in biomedical research remain fresh in people’s minds,” Nembhard noted.
She highlighted the Tuskegee Syphilis Study, in which researchers observed Black men living with syphilis without offering them effective treatments such as penicillin – without their consent – from 1942 until 1972 when an advisory panel determined it to be unethical.
Nembhard identified several barriers, such as language, cultural competency and limited funding and personnel as barriers for multilingual studies. She noted how most studies use questionnaires only validated with English or mostly white populations for questionnaire validation purposes; making sure culturally appropriate versions exist that translate surveys to multiple languages may prove challenging and costly; hiring multilingual staff who can administer study protocols can also prove cost effective solutions.
What needs to be done
Addressing disparate barriers to participation requires finding unique solutions; Greenberger mentioned telehealth as being considered for clinical trials where applicable.
Studies that address common barriers such as transportation, childcare and clinic hours typically show an increase in participation from minority populations,” Nembhard stated.
Addressing distrust can be more of a challenging endeavor; yet Nembhard sees opportunities there as well.
“Partnering with communities of color to design research studies or conduct the study has proven extremely successful at increasing minority participation in clinical trials,” according to Ms. Devereux.
Nembhard noted that focus groups and community boards, which convene local leaders as advisers for research teams, can help direct design of research initiatives to address specific community concerns.
“Many researchers have worked tirelessly to build trust within communities and partner with members to conduct research that benefits both them and science,” according to her.