Equitable inclusion of diverse populations in oncology clinical trials: deterrents and drivers

Abstract

The burden of cancer exerts a disproportionate impact across different regions and population subsets. Disease-specific attributes, coupled with genetic and socioeconomic factors, significantly influence cancer treatment outcomes. Precision oncology promises the development of safe and effective options for specific ethnic phenotypes and clinicodemographic profiles. Currently, clinical trials are concentrated in resource-rich geographies with younger, healthier, white, educated, and empowered populations. Vulnerable and marginalized people are often deprived of opportunities to participate in clinical trials. Despite consistent endeavors by regulators, industry, and other stakeholders, factors including diversity in trial regulations and patient and provider-related cultural, logistic, and operational barriers limit the inclusiveness of clinical trials. Understanding and addressing these constraints by collaborative actions involving regulatory initiatives, industry, patient advocacy groups, community engagement in a culturally sensitive manner, and designing and promoting decentralized clinical trials are vital to establishing a clinical research ecosystem that promotes equity in the representation of population subgroups.

Keywords: clinical trials; diversity; equity; inclusion; regulators.

Figure 1

Oncology trial-specific diversity and inclusion guidance documents issued by the FDA. CNS, central nervous system; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; US FDA, United States Food and Drug Administration.

Figure 2

Barriers to inclusive participation in cancer clinical trials and facilitators of diversity and inclusion.