Analysis of Drug Clinical Trials in Obstetrics and Gynecology: A Five-Year Retrospective Study from a Public Tertiary Specialty Hospital in China

Women remain underrepresented in clinical drug development despite their unique biological characteristics and growing disease burden. In China, this disparity is particularly concerning given the rising incidence of gynecologic conditions such as uterine cancer. This study examined the profile and trends of obstetrics and gynecology (OBGYN) drug trials conducted at a large tertiary specialty hospital in China. A retrospective review of interventional drug trials registered between 2019 and 2023 was conducted using data from the Chinese Clinical Trial Registry (ChiCTR) and the hospital's Clinical Trial Management System. All eligible trials conducted at the Women's Hospital, School of Medicine, and Zhejiang University were included. Information on trial design, year of initiation, clinical specialty, drug category, and primary indication was extracted and analyzed descriptively. A total of 59 interventional drug trials were identified. The trial volume increased from 4 studies in 2019 to 11 in 2023, representing 176% growth. Most trials were domestic multicenter studies (68%), and 71% remained ongoing at the end of 2023. Gynecologic oncology accounted for the largest proportion of trials (44%), followed by gynecology (29%). Ovarian cancer was the leading oncologic indication, while endometriosis and assisted reproduction were the most common benign conditions studied. Antibody-drug conjugates, poly(ADP-ribose) polymerase (PARP) inhibitors, and programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors predominated in oncology trials, whereas hormonal and microbial therapies were more common in non-oncologic studies. OBGYN drug research in China has expanded substantially, with a strong focus on gynecologic cancers and chronic gynecologic conditions. However, maternal health-related drug development remains limited. Continued and systematic monitoring of ChiCTR data may help support more balanced and equitable research priorities across women's health.