Principal investigator sex and trial success: an analysis of early discontinuation, results reporting, and publication

To characterize United States (US) obstetric clinical trials by principal investigator (PI) sex and analyze the association between PI features of trial success. This is a cross-sectional study all US-based registered on ClinicalTrials.gov (2007-2020). We examined associations three primary outcomes: early discontinuation, results reporting complete to ClinicalTrials.gov, publication PubMed.gov, controlling for number sites, PIs, funding source, year. conducted exploratory analyses other features. Of 1287 trials, 1046 (81.2%) listed information. Trials included female (F:627 59.9%), male (M:375, 35.9%), or both PIs (B:44, 4.2%). Most (946, 90.4%) reported one PI. The distribution was largely unchanged over period (Figure 1A). A lower proportion were discontinued (F:5.7%, M:12.0%, B:9.1%; p=0.002), whereas frequencies did not differ significantly (p >0.05, Figure 1B). In multivariable analysis, had odds discontinuation than (adjusted ratio 0.43, 95% confidence interval 0.27-0.69), but demonstrated no differences in 2). Female similar randomization, blinding, use an active comparator industry-funded (F:1.0%, M:2.4%, B:4.5%; p=0.05), oversight data monitoring committee (F:35.1%, M:41.6%, B:54.5%; multiple sites (F:16.7%, M:22.1.6%, B:36.4%; p=0.002). recent years, majority led although remained obstetricians. Female-led less likely discontinue with regard characteristics success, such as publication.View Large Image ViewerDownload Hi-res image Download (PPT)