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

Summary

The current protocol aims to systematically outline the scope, current trends, and treatment focus of interventional drug clinical trials in obstetrics and gynecology at the leading tertiary hospitals in China, and to identify gaps in women's health research and guide the equitable prioritization of further trials.

Abstract

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.

Introduction

Women experience various sex-specific gynecological conditions, including endometriosis, ovarian cancer, cervical cancer, and vaginal diseases^1,2, which require consideration of disease-specific pathophysiology and therapeutic factors in clinical trial design³. The occurrence, course, and prognosis of these diseases can be quite different from those dominating in men, highlighting the historical limitations of extrapolating findings from predominantly male-based clinical research to women-specific health conditions and therapeutic responses. Such biological differences have s....

Protocol

This study involved secondary analysis of de-identified, publicly available registry data and institutional administrative records. In accordance with institutional guidelines and national regulations, the Ethics Committee of the Women's Hospital, School of Medicine, Zhejiang University, waived ethical approval, as the study did not involve human participants, identifiable personal data, or interventional procedures. A formal waiver reference number was not issued for this study.

Study design and data sources
A retrospective review of interventional drug trials registered between 2019 and 2023 was conducted. The a....

Results

Analysis of drug clinical trials conducted at Women's Hospital, School of Medicine, Zhejiang University, from January 1, 2019, to December 31, 2023, identified a total of 59 projects. These comprised 40 domestic multicenter trials (68%) and 19 international multicenter trials (32%). The hospital served mainly as a participating site (57, 97%). By December 31, 2023, 42 trials were ongoing (Table 2). Formal subgroup comparisons between ongoing and completed trials were not performed due to the limited samp.......

Discussion

This descriptive portfolio analysis summarizes 59 interventional drug clinical trials conducted at a tertiary obstetrics and gynecology hospital in China over five years. Although the limited sample size limits the strength of the inference, the results provide a validated institutional picture of women's health-oriented drug development and demonstrate how registry data, when cross-validated with institutional Clinical Trial Management Systems (CTMS), can be used to benchmark trials and strategize.

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Chinese Clinical Trial Registry (ChiCTR) – Drug Clinical Trial Registration and Information Publicity Platform	http://www.chinadrugtrials.org.cn	National Medical Products Administration (NMPA), China	Used to identify registered drug clinical trials and obtain trial registration information for data extraction
Hospital Clinical Trial Management System (CTMS)	https://gcp.womanhospital.cn	Women’s Hospital, School of Medicine, Zhejiang University	Used to retrieve clinical trial records, monitor study progress, and verify trial-related information.
IBM SPSS Statistics for Windows, Version 27.0	Version 27.0	IBM Corp., Armonk, NY, USA	Used for descriptive statistics, linear regression, and χ² analysis
Microsoft Excel	Microsoft365 Excel	Microsoft Corporation	Used for standardized data extraction, variable coding, and data organization
R Statistical Software	Version 4.3.2	R Foundation for Statistical Computing, Vienna, Austria	Used for statistical analysis and trend modeling
STROBE Statement Checklist	https://www.strobe-statement.org/	EQUATOR Network	Reporting guideline for cross-sectional observational studies