Race and ethnicity do not impact eligibility for remdesivir: A single-center experience

Abstract

As the Coronavirus-2019 (COVID-19) pandemic continues, multiple therapies are rapidly being evaluated for efficacy in clinical trials. Clinical trials should be racially and ethnically representative of the population that will eventually benefit from these medications. There are multiple potential barriers to racial and ethnic minority enrollment in clinical trials, one of which could be that inclusion and exclusion criteria select for certain racial or ethnic groups disproportionately. In this observational cohort study at a single health care system, we examined if there were differences in eligibility for treatment with remdesivir based on clinical trial criteria for racial and ethnic minorities compared to non-Hispanic Whites. 201 electronic medical record charts were reviewed manually. Self-identified Whites were older than other racial or ethnic groups. At the time of presentation, Black, Latinx, and White participants met inclusion criteria for remdesivir at similar rates (72%, 80%, and 73% respectively), and exclusion criteria at similar rates (43%, 38% and 49% for Black, Latinx and White participants respectively). In this study, there was no difference in eligibility for remdesivir based on race or ethnicity alone.

Demographic Diversity of Clinical Trials for Therapeutic Drug Products: A Systematic Review of Recently Published Articles, 2017‐2022

“…It is important to address historical, ethical, environmental, and cultural biases at the institutional, community, and patient levels to increase diversity in clinical trial enrollment. 7,10,13,20,33 There is considerable variability in the trial participation of certain ethnic or racial populations even when trials are conducted by the same sponsor. For example, in an analysis of Pfizer trials, Rottas et al 16 found that Black patient participation was variable across different therapeutic areas.…”

“…Additional studies to substantiate conclusions made by authors of the selected articles are needed for identifying the context in which low enrollment occurred (eg, lack of eligibility or inadequate enrollment techniques for underrepresented groups). 33 For example, only 1 study in our review mentioned racial and ethnic differences between Phase 1 and Phase 3 trials. 27 Differences between Phase 1 and Phase 3 trial participation (eg, age, race, ethnicity, household income) may be related to variations in recruitment practices (eg, location of clinics, physician involvement, financial compensation).…”

“…To increase CT participation among diverse populations, studies reviewed suggested strengthening federal collaboration (eg, National Institutes of Health and FDA with other interested parties, such as clinicians) 7,13,28 ; conducting targeted studies to identify barriers to minority representation 28 ; optimizing CT eligibility criteria to eliminate arbitrary exclusions 33 ; increasing diversity among the trial investigation team 17 ; oversampling certain groups to better estimate group attributes when necessary 46 ; and supporting legislation, regulations, and policies that endorse demographic data collection and reporting. 31 The FDA has also provided recommendations for improving CT diversity and published several guidance documents for the industry to facilitate the enrollment and retention of a diverse trial population, including enrichment strategies, flexible modifications in trial practices, and more inclusive methodological approaches and designs.…”

“…Additionally, some trials in our analysis had small sample sizes and undefined or unclear methods for ascertainment of exposure or disease outcomes, and differed in study design, quality, or outcomes measured. 19,20,25,29,33 Thus, we could not pool or quantify results across all studies or perform a meta-analysis. Further exploration of the methods used to evaluate CT diversity may inform best practices to promote consistency across trials.…”

“…Thirteen articles found that historically underrepresented racial and ethnic minority populations were not adequately represented in CTs. 7,9,10,[14][15][16][17]25,28,[30][31][32][33] Lolic et al 14,15 reported that Asian, American Indian or Alaska Native, and Hispanic or Latino participants in trials were consistently underrepresented in CTs compared to the US census levels. Ajewole et al 32 found that Black populations were underrepresented in CTs leading to FDA approval of oral chemotherapy drugs and in the CTs of the cancer types with the highest mortality rates (lung, breast, and prostate cancers; racial demographics were not reported for colorectal cancer trials and, hence, were excluded from the authors' analyses).…”