The REthinking MeAsures of DivErsity (REMADE) Study: Developing New Diversity Measures to Ensure Fair Representation in Clinical Trials
Jeffrey Yu1, Adrian Kielhorn1, James Murdoch2, Marcus Martin2, Eddilisa Martin2, Kelly McNeil-Posey1, Barbara Mungin1, Yiyi Xia1, Wendy Erler1, Nuwan Kurukulasuriya1
1Alexion, AstraZeneca Rare Disease, 2M&B Sciences
Objective:
Develop and test questions that more accurately capture patient diversity via socioeconomic, cultural, and ethnic parameters versus the standard set of demographic questions used in clinical trials.
Background:
The U.S. Food and Drug Administration has issued several guidance documents aimed at increasing patient diversity in clinical trials. The standard questions on age, sex, race, and ethnicity are limited and contain too few categories to capture diversity or to measure the improvement of diversity. A more comprehensive diversity measure is needed.
Design/Methods:
REMADE was a focus group and survey research study of US adults from underrepresented populations. Qualitative data collected from focus groups were utilized to develop a web-based survey to assess race, ethnicity/culture, socioeconomic status, disability/mobility, and transportation issues. Respondents could select >1 option from each of 7 racial and 17 cultural/heritage/ethnicity categories. Survey results were compared with data collected with a presurvey intake form (PSIF) utilizing standard race and ethnicity/cultural categories.
Results:
Of 219 survey respondents, 60% were assigned female sex at birth; 51% were aged ≥18y to <30y; 53% had health insurance; 66% had mobility issues; and 71% had transportation issues. Most PSIF respondents (n=211) self-reported as Black (77%), but when survey respondents assigned percentages across multiple racial categories, the population averaged 60% Black. By PSIF, the ethnicity distribution was 47% Hispanic/Latino; however, when offered a broad range of regions to define cultural identity, 24.2% selected Hispanic/Latino. Most survey respondents (40.2%) identified with North America. Up to 20.6% total identified with different regions in Africa (multiple choices possible). Self-assessment of skin tone better captured diversity than the current census categories of White and Black/African American.
Conclusions:
The REMADE survey results suggest that race and cultural identity are multidimensional. Broader measures, along with those capturing economic, disability, or transportation issues, will guide clinical trial initiatives to ensure fair and equitable representation and access.
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