Representative study populations

Representative study populations include participants from the different subgroup in a defined population in the same or nearly same proportion as found in that defined population in the real world. Relevant to clinical trials or patient registries, the defined population would be the disease community. In this context, a representative study population accurately reflects the whole disease community, including for example different genetic pathogenic variants that cause the disease.

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.

Sourced From
NIH Grants and Funding Acronym and Glossary List
U.S. Food and Drug Administration (FDA): Diversity in Clinical Trial Participation
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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