Gender disparities in coronavirus disease 2019 clinical trial leadership

Abstract

\n Objectives\n We aimed to compare the gender distribution of clinical trial leadership in COVID-19 clinical trials.\n \n Methods\n We searched https://clinicaltrials.gov/and retrieved all clinical trials on COVID-19 from January 1, 2020 to June 26, 2020. As a comparator group, we have chosen two fields that are not related to emerging infections and infectious diseases: and considered not directly affected by the pandemic: breast cancer and type 2 diabetes mellitus (T2DM) and included studies within the aforementioned study period as well as those registered in the preceding year (pre-study period: January 1, 2019 and December 31, 2019). Gender of the investigator was predicted using the genderize.io API (application programming interface). The repository of the datasets used to collect and analyse the data available at https://osf.io/k2r57/.\n \n Results\n Only 27.8% (430/1548) of principal investigators (PIs) among COVID-19-related studies were women, which is significantly different compared to 54.9% (156/284) and 42.1% (56/133) for breast cancer (p<0.005) and T2DM (p<0.005) trials over the same period, respectively. During this “pre-study” period, the proportion of PIs who were predicted to be women were 49.7% (245/493) and 44.4% (148/333) for breast cancer and T2DM trials, respectively and the difference was not statistically significant when compared to results from the study period (p>0.05).\n \n Conclusion\n We demonstrate that less than one-third of COVID-19-related clinical trials are led by women PIs, half the proportion observed in non-COVID-19 trials over the same period which remained similar to the pre-study period. These gender disparities during the pandemic may indicate not only a lack of women s leadership in international clinical trials and involvement in new projects but also may reveal imbalances in women s access to research activities and funding during health emergencies.\n