An underrepresented population refers to a subgroup of the population whose representation is disproportionately low relative to their numbers in the general population, or in the case of clinical trials or patient registries, disease population. The subgroup may be identified by race, ethnicity, age, sex, gender, socioeconomic status, etc. For example, in biomedical, clinical, behavioral, and social science identified underrepresented populations include people with disabilities, people from disadvantaged backgrounds, and underrepresented racial and ethnic groups such as blacks or African Americans, Hispanics or Latinos, American Indians or Alaskan Natives, and Native Hawaiians and other Pacific Islanders.
The U.S. Food and Drug Administration (FDA) recognizes underrepresented populations to include both demographic populations (e.g., sex, race, ethnicity, age) and non-demographic populations (e.g., patients with organ dysfunction, comorbid conditions, and those at the extremes of the weight range) and that therapies are safer and more effective for everyone when clinical research includes diverse populations.
NIH Grants and Funding Acronym and Glossary List
U.S. Food and Drug Administration (FDA): Diversity in Clinical Trial Participation
U.S. Food and Drug Administration (FDA) Encourages More Participation, Diversity in Clinical Trials
U.S. Food and Drug Administration (FDA): Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry