Mavundza Edison Johannes, Mmotsa Tshiamo Moshading, Ndwandwe Duduzile
Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa.
Hum Vaccin Immunother. 2025 Dec;21(1):2478702. doi: 10.1080/21645515.2025.2478702. Epub 2025 Mar 18.
Clinical trials remain the gold standard for evaluating the effectiveness and safety of health interventions. Every clinical trial is mandated to be registered prospectively in a publicly accessible trial registry before the enrollment of the first participant. The aim of the current study was to provide a cross-sectional analysis of registered HPV vaccine clinical trials listed in the International Clinical Trials Registry Platform (ICTRP). On 05 March 2023, we searched the ICTRP for registered HPV vaccine clinical trials using the term "human papillomavirus vaccine." Two authors independently extracted data including the name of the clinical trial registry, location, recruitment status, gender of participants, phase, primary outcome, and type of sponsor. Our search of the ICTRP resulted in 437 HPV vaccine clinical trials registered between 1999 and 2022. Most of the trials were: registered retrospectively (61.3%, = 268), registered in ClinicalTrials.gov registry (66.8%, = 292), conducted in Europe (26.0%, = 112), not recruiting (80.5%, = 352), in phase 3 (37.3%, = 163), conducted among female participants (64.3%, = 281), studying immune responses (46.7%, = 204), and sponsored by pharmaceutical companies (50.3%, = 220). To increase research transparency, prevent duplication of research, and prevent publication bias, there is an urgent need for all primary registries to make prospective registration mandatory and remain the only type of registration available to trial sponsors. All clinical trial primary registries should also make the completion of all fields compulsory when registering a trial to improve transparency.
临床试验仍然是评估健康干预措施有效性和安全性的金标准。每项临床试验都必须在招募第一名参与者之前，在可公开访问的试验注册库中进行前瞻性注册。本研究的目的是对国际临床试验注册平台（ICTRP）中列出的已注册HPV疫苗临床试验进行横断面分析。2023年3月5日，我们在ICTRP中使用“人乳头瘤病毒疫苗”一词搜索已注册的HPV疫苗临床试验。两位作者独立提取了包括临床试验注册库名称、地点、招募状态、参与者性别、阶段、主要结局和申办者类型等数据。我们对ICTRP的搜索结果显示，在1999年至2022年期间有437项HPV疫苗临床试验注册。大多数试验为：回顾性注册（61.3%，n = 268）、在ClinicalTrials.gov注册库中注册（66.8%，n = 292）、在欧洲进行（26.0%，n = 112）、未招募（80.5%，n = 352）、处于3期（37.3%，n = 163）、在女性参与者中进行（64.3%，n = 281）、研究免疫反应（46.7%，n = 204）以及由制药公司申办（50.3%，n = 220）。为了提高研究透明度、防止研究重复以及防止发表偏倚，所有一级注册库迫切需要强制进行前瞻性注册，并使其成为试验申办者唯一可用的注册类型。所有临床试验一级注册库在注册试验时还应强制要求填写所有字段，以提高透明度。
