Axes of social inequities in COVID-19 clinical trials: A systematic review.

ABSTRACT

Objective: The representativeness of participants is crucial to ensure external validity of clinical trials. We focused on the randomized clinical trials which assessed COVID-19 vaccines to assess the reporting of age, sex, gender identity, race, ethnicity, obesity, sexual orientation, and socioeconomic status in the results (description of the participants' characteristics, loss of follow-up, stratification of efficacy and safety results). Methods: We searched the following databases for randomized clinical trials published before 1st February 2022 PubMed, Scopus, Web of Science, and Excerpta Medica. We included peer-reviewed articles written in English or Spanish. Four researchers used the Rayyan platform to filter citations, first reading the title and abstract, and then accessing the full text. Articles were excluded if both reviewers agreed, or if a third reviewer decided to discard them. Results: Sixty three articles were included, which assessed 20 different vaccines, mainly in phase 2 or 3. When describing the participants' characteristics, all the studies reported sex or gender, 73.0% race, ethnicity, 68.9% age groups, and 22.2% obesity. Only one article described the age of participants lost to follow-up. Efficacy results were stratified by age in 61.9%, sex or gender in 26.9%, race and/or, ethnicity in 9.5%, and obesity in 4.8% of the articles. Safety results were stratified by age in 41.0%, and by sex or gender in 7.9% of the analysis. Reporting of gender identity, sexual orientation or socioeconomic status of participants was rare. Parity was reached in 49.2% of the studies, and sex-specific outcomes were mentioned in 22.9% of the analysis, most of the latter were related to females' health. Conclusions: Axes of social inequity other than age and sex were hardly reported in randomized clinical trials that assessed COVID-19 vaccines. This undermines their representativeness and external validity and sustains health inequities.