Abstract Details

Title The REthinking MeAsures of DivErsity (REMADE) Study: Developing New Diversity Measures to Ensure Fair Representation in Clinical Trials

Topic Practice, Policy, and Ethics

Presentation(s) P1 - Poster Session 1 (11:45 AM-12:45 PM)

Poster/Presentation
Number 1-011

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.

Authors/Disclosures
Kelly McNeil-Posey, RN (Alexion, Astra Zeneca) PRESENTER	Mrs. McNeil-Posey has received personal compensation for serving as an employee of Alexion Pharma.
Jeffrey Yu, PhD (Alexion)	Dr. Yu has received personal compensation for serving as an employee of Alexion. Dr. Yu has stock in AstraZeneca.
Adrian Kielhorn	Adrian Kielhorn has received personal compensation for serving as an employee of Alexion. Adrian Kielhorn has stock in Alexion.
Jim C. Murdoch, PhD	Dr. Murdoch has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for M&B Sciences. Dr. Murdoch has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for XOME.
Marcus M. Martin, PhD	Dr. Martin has nothing to disclose.
Eddilisa Martin, PHARMD	Dr. Martin has nothing to disclose.
Barbara Mungin, PhD (Alexion)	Dr. Mungin has nothing to disclose.
Yiyi Xia	Ms. Xia has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Ms. Xia has stock in Astrazeneca.
Wendy Erler, MBA	Mrs. Erler has received personal compensation for serving as an employee of Alexion Astra Zeneca. Mrs. Erler has stock in Alexion Astra Zeneca.
Nuwan Kurukulasuriya	Dr. Kurukulasuriya has received personal compensation for serving as an employee of AstaZeneca/Alexion. Dr. Kurukulasuriya has received personal compensation for serving as an employee of AstraZeneca/Alexion. Dr. Kurukulasuriya has stock in AstraZeneca/Alexion. Dr. Kurukulasuriya has stock in AstraZeneca/Alexion.

��ɫ��

��ɫ��