COVID-19 disparities: An urgent call for race reporting and representation in clinical research

Background: Racial/ethnic disparities in disease burden have gained the spotlight in the United States with the spread of SARS-CoV-2 and surge of COVID-19 cases. The problem of underrepresentation in clinical research persists today. In light of the considerable COVID-19 disparities observed, this study sought to assess the race reporting and representation among COVID-19 therapeutic studies published to date.

Methods: All published COVID-19 treatment-related clinical research studies with study participants in the United States were identified. For each study, the date published, treatment investigated, study design, race/ethnicity of participants, sample size and study site were recorded. For each study site, the race/ethnicity demographics of confirmed COVID-19 positive cases were identified utilizing online publicly available department of public health data.

Results: Six studies (n = 3, observational; n = 3, randomized clinical trial) have been published to date with participants in the United States. A subset (n = 4) reported race/ethnicity data in the publication. Black patients were underrepresented in all studies relative to the affected population in the cities in which the studies took place.

Conclusions: Given that racial/ethnic disparities in COVID-19 disease burden and outcomes have emerged in the United States, it is essential that all investigators uniformly report race/ethnicity data as well as attempt, in earnest, to obtain representativeness among study participants in order to ensure that we do not develop a further widening of the treatment gap during this pandemic.