Department of Obstetrics and Gynecology, Northwestern Feinberg School of Medicine, Chicago, Illinois; the Division of Urological Surgery, Brigham and Women's Hospital, Harvard Medical School, the Harvard Radiation Oncology Program, and the Brigham and Women's Hospital/Mass General Hospital Integrated Residency Program in Obstetrics and Gynecology, Boston, Massachusetts; the Department of Obstetrics and Gynecology, University of Tennessee Health Science Center, Memphis, Tennessee; the Department of Obstetrics and Gynecology, University of California, Los Angeles, Los Angeles, the UCSF School of Medicine, San Francisco, and the Stanford University School of Medicine, Stanford, California; the Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; and the Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Washington, Seattle, Washington.
Obstet Gynecol. 2022 May 1;139(5):821-831. doi: 10.1097/AOG.0000000000004735. Epub 2022 Apr 5.
To characterize gynecology clinical trials over time, compare gynecology subspecialties, and analyze factors associated with early discontinuation, results reporting, and publication.
We conducted a cross-sectional analysis of all gynecology trials registered on ClinicalTrials.gov between 2007 and 2020 and their resulting publications. Trials were analyzed with descriptive, multivariable logistic, and Cox regression analyses. Primary exposure variables were trial funding and subspecialty. The three primary outcomes included early discontinuation, results reporting to ClinicalTrials.gov, and publication in a peer-reviewed journal indexed on PubMed.
Of 223,690 trials registered on ClinicalTrials.gov between October 2007 and March 2020, only 3.7% focused on gynecology (n=8,174, approximately 3,759,086 participants). Subspecialties included 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%). Only 42.0% of completed trials disseminated results through results reporting and publication. Of all funding types, industry-funded trials were the most likely to be discontinued early (P<.001). Academic-funded trials were the least likely to report results (adjusted odds ratio [aOR] 0.38, 95% CI 0.30-0.50) but the most likely to publish (aOR 1.62, 95% CI 1.24-2.12). The number of reproductive endocrinology and infertility trials increased the most of any subspecialty between 2007 and 2020 (6.4% growth rate). Reproductive endocrinology and infertility and family planning trials were the most likely to be stopped early (reproductive endocrinology and infertility: adjusted hazard ratio [aHR] 2.08, 95% CI 1.59-2.71; family planning: aHR 1.55 95% CI 1.06-2.25). When completed, reproductive endocrinology and infertility trials were the least likely to report results (aOR 0.58, 95% CI 0.38-0.88). No significant differences were seen between subspecialties with respect to publication.
Gynecology trials comprise only 3.7% of all clinical trials. The paucity of gynecology clinical trials aligns with decades of female underrepresentation in research. When completed, gynecology trials have poor dissemination. Our findings raise concern about bias in the performance, reporting, and publication of gynecology clinical trials.
描述妇产科临床试验随时间的变化情况，比较妇产科各亚专业，并分析与提前终止、结果报告和发表相关的因素。
我们对 2007 年至 2020 年期间在 ClinicalTrials.gov 上注册的所有妇产科试验及其相关出版物进行了横断面分析。采用描述性、多变量逻辑和 Cox 回归分析对试验进行分析。主要暴露变量为试验资助和亚专业。三个主要结局包括提前终止、向 ClinicalTrials.gov 报告结果和在 PubMed 索引的同行评审期刊上发表。
在 2007 年 10 月至 2020 年 3 月期间在 ClinicalTrials.gov 上注册的 223690 项试验中，只有 3.7%（n=8174，约 3759086 名参与者）专注于妇产科。亚专业包括生殖内分泌和不孕（n=1428，17.5%）、妇科肿瘤学（n=2063，25.2%）、尿失禁（n=1118，13.7%）、计划生育（n=648，7.9%）和其他良性妇科（n=2917，35.7%）。只有 42.0%的完成试验通过结果报告和发表传播了结果。在所有资助类型中，工业资助的试验最有可能提前终止（P<.001）。学术资助的试验最不可能报告结果（调整后的优势比[aOR]0.38，95%CI0.30-0.50），但最有可能发表（aOR1.62，95%CI1.24-2.12）。生殖内分泌和不孕试验是所有亚专业中在 2007 年至 2020 年期间增长最多的（增长率为 6.4%）。生殖内分泌和不孕以及计划生育试验最有可能提前终止（生殖内分泌和不孕：调整后的危险比[aHR]2.08，95%CI1.59-2.71；计划生育：aHR1.55，95%CI1.06-2.25）。当完成时，生殖内分泌和不孕试验最不可能报告结果（aOR0.58，95%CI0.38-0.88）。在发表方面，各亚专业之间没有显著差异。
妇产科试验仅占所有临床试验的 3.7%。妇产科临床试验的缺乏与几十年来女性在研究中的代表性不足相吻合。当完成时，妇产科试验的传播效果不佳。我们的研究结果引发了对妇产科临床试验的执行、报告和发表中存在偏见的担忧。
