Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa.
Hum Vaccin Immunother. 2024 Dec 31;20(1):2393481. doi: 10.1080/21645515.2024.2393481. Epub 2024 Aug 28.
Every clinical trial must be registered in a publicly accessible trial registry before enrollment of the first participant. Prospectively registering clinical trials before enrolling participants helps to prevent unethical research misconduct from occurring, duplication of research and increases transparency in research. The aim of this study was to provide cross-sectional survey analysis of planned, ongoing and completed human papillomavirus (HPV) clinical trials conducted worldwide. We searched the International Clinical Trials Registry Platform (ICTR) for registered HPV trials on 5 March 2023. Two authors independently extracted data including name of the clinical trial registry, location of the trial, recruitment status of the trial, gender of participants, phase of the trial, and type of trial sponsor. We used Microsoft Excel to perform descriptive analysis. The search yielded 1632 trials registered between 1999 and 2023. Most of the trials were registered in ClinicalTrials.gov and were registered retrospectively. We also found that most trials were conducted in North America, in recruiting stage, and indicated "not applicable" under the phase of the trial field. Finally, most trials were sponsored by hospitals. Our study found that there are many HPV clinical trials registered in different clinical trial primary registries around the world. However, many of the trials were registered retrospectively instead of the required prospectively and some had missing fields. Therefore, there is a need for registries to promote prospective trial registration and completion of all fields during the registration process.
每个临床试验都必须在招募第一个参与者之前在一个公开可访问的试验注册处进行注册。在招募参与者之前前瞻性地注册临床试验有助于防止不道德的研究不当行为发生,避免研究重复,并提高研究的透明度。本研究的目的是提供对全球范围内计划、进行和完成的人乳头瘤病毒(HPV)临床试验的横断面调查分析。我们于 2023 年 3 月 5 日在国际临床试验注册平台(ICTR)上搜索了已注册的 HPV 试验。两名作者独立提取了数据,包括临床试验注册名称、试验地点、试验招募情况、参与者性别、试验阶段和试验赞助商类型。我们使用 Microsoft Excel 进行描述性分析。搜索结果显示,1999 年至 2023 年间共注册了 1632 项试验。大多数试验在 ClinicalTrials.gov 注册,并且是回溯性注册的。我们还发现,大多数试验在北美进行,处于招募阶段,并且在试验阶段字段下标记为“不适用”。最后,大多数试验由医院赞助。我们的研究发现,全球许多不同的临床试验注册处都有许多 HPV 临床试验注册。然而,许多试验是回溯性注册的,而不是前瞻性注册的,并且有些字段缺失。因此,注册处需要促进前瞻性试验注册,并在注册过程中完成所有字段。