Sex and Race Reporting and Representation in Noncancerous Voice Clinical Trials: A Meta-Analysis of National Institutes of Health-Registered Research Between 1988 and 2021.

Abstract

The purpose of this meta-analysis was to assess the frequency of sex, race, and ethnicity reporting and proportional representation in funded, noncancerous voice clinical trials to determine the state of compliance with National Institutes of Health (NIH) guidelines for inclusivity in clinical research. Clinical trials registered with the NIH/U.S. National Library of Medicine between January 1988 and September 2021 were analyzed. Primary reports of the trials were obtained from clinicaltrials.gov and PubMed. Outcomes included the proportion of trials reporting sex, race, and ethnicity and the proportion of participants by sex, race, and ethnicity in the trials. Descriptive statistics and chi-square tests were used to analyze the data with 95% confidence intervals (CIs) reported. The search yielded 46 research studies. After inclusion and exclusion criteria were applied and attempts to locate studies were conducted, 11 total articles were ultimately evaluated. Descriptively, there were more female subjects, yet overall, no significant difference in sex distribution (χ2 = 0.07, p = .75, 95% CI [-0.25, -0.19]). Race and ethnicity were only reported in two clinical trials. Black participants were underrepresented in one clinical trial (χ2 = 4.93, p = .02, 95% CI [-0.11, -0.02]), whereas Hispanic participants were underrepresented in a second trial (χ2 = 11.27, p < .00, 95% CI [-0.20, - 0.13]). This preliminary analysis highlights the disparities in race and ethnicity recruitment and reporting in noncancerous voice clinical trials. There is a need for strategic recruitment strategies and improved reporting practices to adhere to the NIH inclusivity directives.