Do Federal Regulations Affect Gender, Racial, and Ethnic Disparities in Chronic Rhinosinusitis Research?

Abstract

Objective The Food and Drug Administration and the National Institutes of Health (NIH) have asserted that diverse demographic representation in clinical trials is essential. In light of these federal guidelines, the objective of this study is to assess the racial, ethnic, and gender demographics of patients enrolled in clinical trials registered with the NIH that evaluate chronic rhinosinusitis with nasal polyposis (CRSwNP) relative to the demographics of the US population. Study Design Cross-sectional study. Setting Not applicable. Methods ClinicalTrials.gov was queried to identify all prospective clinical trials for CRSwNP. Individual study and pooled data were compared with national US census data. Results Eighteen studies were included comprising 4125 patients and evaluating dupilumab, mepolizumab, omalizumab, fluticasone/OptiNose, MediHoney, mometasone, and SINUVA. Women constituted 42.7% of clinical trial participants. Of the 4125 participants, 69.6% identified as White, 6.6% as Black, 20.8% as Asian, 0.1% as Pacific Islander, 0.4% as American Indian, 8.0% as Hispanic, and 2.4% as other. The racial, ethnic, and gender composition of the pooled study population differs significantly from national US census data, with underrepresentation of Black, Hispanic, Pacific Island, and American Indian individuals, as well as females ( P < .05). Conclusion The racial, ethnic, and gender demographics of patients enrolled in CRSwNP clinical trials registered with the NIH differ significantly from the demographics of the US population, despite federal guidelines advising demographically representative participation. Proactive efforts to enroll participants that better represent anticipated treatment populations should be emphasized by researchers, institutions, and editorial boards.

Avoiding bias in artificial intelligence

“…A systematic review of prospective chronic rhinosinusitis (CRS) studies in the United States, encompassing over 12,000 patients, demonstrated that every demographic and ethnic minority was significantly underrepresented relative to its portion of the population (and probably relative to its share of CRS patients) 5 . Separate analyses of prospective clinical trials studying CRS and rhinitis through the National Institute of Health and the US Food and Drug Administration have also found that women and minorities are routinely underrepresented 6–8 . It is not hard to imagine a scenario where insurance companies utilize input from these biased data sets to create an algorithm to determine risk of disease progression, for example, and disproportionately deny sinus surgery coverage for women or minorities based on a skewed interpretation of responses to nonsurgical therapy.…”

“…5 Separate analyses of prospective clinical trials studying CRS and rhinitis through the National Institute of Health and the US Food and Drug Administration have also found that women and minorities are routinely underrepresented. [6][7][8] It is not hard to imagine a scenario where insurance companies utilize input from these biased data sets to create an algorithm to determine risk of disease progression, for example, and disproportionately deny sinus surgery coverage for women or minorities based on a skewed interpretation of responses to nonsurgical therapy.…”