Progress Report Shows Work Still Needed to Address Health Disparities in Clinical Trials

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  • September 28, 2021

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In 1993, the NIH Revitalization Act was signed into law, directing the NIH to establish guidelines for inclusion of women and minorities in clinical research. Nearly three decades later, on the heels of 2020’s strident calls for health equity, a look at cancer clinical trials shows that underrepresentation persists for both women and minorities.

A recent study published in JAMA Oncology that looked specifically at the participation of women in oncology clinical trials in six cancer types (lung, colon, thyroid, kidney and pancreatic cancers, and melanoma) concluded that sex inequalities persist and that men nearly always outnumbered women, regardless of trial phase, cancer type, time period, or cancer incidence in the female population. Overall, 40% of trial participants were women, who were underrepresented for all of the cancer types except pancreatic cancer. In addition, the differences in enrollment between the sexes were significant for all trial phases.

The 2020 Drug Trials Snapshots Summary Report from the U.S. Food and Drug Administration also shows that a significant imbalance persists in representation of minorities in oncology clinical trials, with Black Americans representing 5% of trial participants and Hispanic Americans representing 6%, while their proportion of the U.S. population is 13.4% and 18.1%, respectively.

The 1993 NIH Revitalization Act says: “The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design or contract proposal appropriate to the scientific objectives of the study/contract. The research plan/proposal should describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan/proposal should contain a description of the proposed outreach programs for recruiting women and minorities as participants.It also says that “…cost is not an acceptable reason for exclusion of women and minorities from clinical trials.”

These days, a renewed interest in fulfilling the original intentions of the Revitalization Act is showing up in new approaches to clinical trial recruitment: exploration of nontraditional partnerships, local activation in communities, and development of resources geared to specific populations. But the most important aspect of expanding the clinical trial universe begins with companies and institutions understanding the needs and barriers that are unique to each community and making meaningful commitments to address those obstacles.

Nearly 30 years after the NIH Revitalization Act was signed into law, it’s clear that there is still work to be done and that to meaningfully help our entire population, we must strive for research that represents everyone. Learn more about health disparities and clinical trials and what you can do to help address them.