For a study, researchers sought to compare gynecology subspecialties and examine variables related to early discontinuation, results reporting, and publishing of gynecology clinical trials throughout time. They performed a cross-sectional study of all gynecological studies registered on ClinicalTrials.gov between 2007 and 2020, as well as the publications that resulted from them. Descriptive, multivariable logistic, and Cox regression analyses were used to examine the trials. Trial funding and specialization were the primary exposure factors. Early termination, results reporting to ClinicalTrials.gov, and publication in a peer-reviewed journal indexed on PubMed were the three key objectives.
Only 3.7% of the 223,690 studies registered on ClinicalTrials.gov between October 2007 and March 2020 focused on gynecology (n=8,174, or about 3,759,086 people). Reproductive endocrinology and infertility (n=1,428, 17.5%), gynecologic oncology (n=2,063, 25.2%), urogynecology (n=1,118, 13.7%), family planning (n=648, 7.9%), and other benign gynecology (n=2,917, 35.7%) were among the subspecialties. Only 42.0% of completed studies communicated their findings via results reporting and publishing. Industry-funded studies had the highest rate of early termination (P<.001). Academic-funded trials were the least likely to disclose findings (aOR 0.38, 95% CI 0.30–0.50), but the most likely to publish (aOR 1.62, 95% CI 1.24–2.12). Between 2007 and 2020, the number of trials in reproductive endocrinology and infertility rose the greatest of any subspecialty (6.4% growth rate). Trials in reproductive endocrinology and infertility and family planning were the most likely to be terminated prematurely (reproductive endocrinology and infertility: aHR 2.08, 95% CI 1.59–2.71; family planning: aHR 1.55, 95% CI 1.06–2.25). Reproductive endocrinology and infertility studies were the least likely to disclose findings when completed (aOR 0.58, 95% CI 0.38–0.88). In terms of publishing, there were no notable disparities across subspecialties.
Gynecology studies accounted for just 3.7% of all clinical trials. The lack of gynecological clinical trials corresponded to decades of female underrepresentation in research. Gynecology trials were poorly disseminated once they were done. The findings highlighted concerns regarding bias in gynecological clinical trial performance, reporting, and publishing.
