OBJECTIVES: Racial and ethnic minority groups are underrepresented in clinical research, and disparities in health outcomes between minority and non-minority groups are well documented. The FDA released guidance in 2022 to improve enrollment from underrepresented groups in clinical trials, and similar issues of representative inclusion exist in patient-centered research. The objective of this conceptual piece is to reflect on barriers and strategies for achieving a racially/ethnically representative sample in COA research as an aspect of clinical research.

METHODS: Researchers from a health outcomes research consultancy convened to identify current strategies and barriers to adequate representation of racial and ethnic minorities in COA research.

RESULTS: Recruitment methods, demographic data collection, reporting in scientific literature, and researcher bias emerged as barriers to inclusion in COA research. Typical recruitment methods are susceptible to participant self-selection bias and may exclude harder-to-reach individuals. Researchers should pre-specify recruitment targets that reflect the general population or appropriate representation from all racial/ethnic categories and engage directly with members of minority groups and recruitment groups to develop and achieve targets. In addition, demographic data collection forms may not encompass all possible race/ethnicity responses. These forms should be revised to ensure accurate race and ethnicity data collection. Similarly, race and ethnicity data of COA research participants are not consistently reported in scientific literature. Researchers should ensure complete demographic data are reported when disseminating results and sub-group analyses conducted when possible so that differences based on race or ethnicity can be documented. Further, researcher biases can inadvertently limit inclusive recruitment efforts. Research staff should undergo training on topics such as unconscious bias and approaches to ensuring geographic representation to support recruitment of diverse samples.

CONCLUSIONS: Underrepresentation of racial and ethnic minorities in COA research inhibits applicability of results to these groups. Intentional efforts to overcome barriers to inclusion should remain a priority in COA research.